BDI Pharma, LLC 2018 Product Reference Charts

Transcription

1 BDI Pharma, LLC 2018 Product Reference Charts Protein Therapies

2 Intravenous Immune Globulin (10%) BIVIGAM NF ADMA Biologics Flebogamma 10% DIF GAMMAGARD LIQUID Gammaked Kedrion BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI) Primary Immune Deficiency (PID), Chronic Primary Immune Thrombocytopenia (ITP) in patients 2 years of age and older. Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy [MMN]. Gammaked is an immune globulin injection (human), 10% liquid indicated for treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic Purpura (ITP) in adults and children, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults. Gammaked may also be administered subcutaneously for the treatment of PI. BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. BIVIGAM is contraindicated in IgA deficiency patients with antibodies to IgA and a history of hypersensitivity. Individuals who have had a history of anaphylactic or severe systemic reactions to the administration of human immune globulin and IgA deficient patients with antibodies to IgA and a history of hypersensitivity. 1. In patients who have had a history of anaphylactic or severe systemic hypersensitivity reaction to the administration of human immune globulin. 2. In IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous use. Gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Gammaked is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. IgA Content 200 mcg/ml Flebogamma 10% DIF contains trace amounts of IgA (typically less than 100 μg/ml) Average: 3.1 μg/ml The average immunoglobulin A (IgA) concentration is 37 mcg/ml (in a 10% solution). Average 46 mcg/ml Osmolality mosm/kg mosm/kg mosmol/kg 258 mosmol/kg Sugar Content BIVIGAM does not contain sucrose 5% D-sorbitol (polyol) No sugar added Gammaked does not contain sucrose Sodium Content M sodium chloride Trace (< 3.2 mmol/l) No sodium added Trace amounts ph of Product The ph of the solution ranges from 5 to 6. Average: 5.5 ± Product Half Life The median terminal half-life of BIVIGAM was 30 days 3-week dosing interval: 34 ± 10 days; 4-week dosing interval: 37 ± 13 days days for Intravenous use Approximately 35 days Process Precipitation and removal of fraction III removes both enveloped and nonenveloped viruses, solvent/detergent treatment represents a virus inactivation step for enveloped viruses, and 35 nm virus filtration removes both enveloped and nonenveloped viruses by size exclusion Pasteurization at 60 ºC, 10 hours, solvent-detergent treatment for 6 hours and nanofiltration down to 20 nm Planova filters. Fraction I precipitation, Fraction II+III precipitation, 4% PEG precipitation and ph treatment for 4 hours at 37 ºC). Solvent Detergent, 35 nm filtration, incubation (elevated temp) at low ph Gammaked is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. Gammaked is incubated in the final container (at the low ph of ). Route of Administration Intravenous (IV) Intravenous (IV) Intravenous (IV) or Subcutaneous (SC) Intravenous (IV): CIDP, PI, ITP. Check prescribing information for initial and maintenance infusion rates. Subcutaneous (SC): PI. Initial rate 20 ml/hr/site. Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. Formulation & Concentration 10% Liquid 10% Liquid 10% Liquid 10% Liquid Refrigerate between 2 to 8 C (36 to 46 F) Do not freeze or heat. Do not use any solutions that have been frozen or heated. Allow refrigerated product to come to room temperature before use. Do not use after expiration date. Room temperature storage: + 2 to + 25 C (36 F to 77 F). Do not freeze. Do not freeze. Store GAMMAGARD LIQUID in the refrigerator or at room temperature. Refrigeration: 2 to 8 C [36 to 46 F] for up to 36 months. Room Temperature: up to 25 C [77 F] for up to 24 months. Expiration dates for both storage conditions are printed on the outer carton and vial label. Do not use past the applicable expiration date. 36 months at refrigerated temperature 2-8 C (36-46 F). Do not freeze. 6 months at temperatures not to exceed 25 (77 F) anytime during the 36-month shelf life. Shelf Life from Date of Manufacture 24 months 24 months 24 months at room temperature, 36 months when refrigerated, or until expiration date. 36 months. Do not use after the labeled expiration date. How Supplied 5 g protein in (50 ml) single-use, tamper-evident vial 10 g protein in (100 ml) single-use, tamper-evident vial 5 g (50 ml), 10 g (100 ml), and 20 g (200 ml) 1.0 g, 2.5 g, 5 g, 10 g, 20 g, 30 g 1 g (10 ml), 2.5 g (25 ml), 5 g (50 ml), 10 g (100 ml), 20 g (200 ml)

3 Intravenous Immune Globulin (10%) Continued Gammaplex 10% BPL Gamunex-C Octagam 10% Octapharma Privigen Primary Humoral Immunodeficiency (PI) in adults, Chronic Immune Thrombocytopenic Purpura (ITP) in adults GAMUNEX-C is an immune globulin injection (human), 10% liquid indicated for treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic Purpura (ITP) in adults and children, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults. GAMUNEX-C may also be administered subcutaneously for the treatment of PI. Chronic immune thrombocytopenic purpura (ITP) in adults. Primary Humoral Immunodeficiency (PI), Chronic Immune Thrombocytopenic Purpura (ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients who have a history of anaphylactic or severe systemic reactions to human immune globulin and IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. GAMUNEX-C is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies against IgA and a history of hypersensitivity. Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Patients with hyperprolinemia. Patients with selective IgA deficiency with antibodies to IgA and a history of hypersensitivity. IgA Content < 20 mcg/ml Average 46 mcg/ml Trace amounts (average 106 μg/ml in a 10% solution). 25 mcg/ml Osmolality Typically 280 mosmol/kg 258 mosmol/kg mosmol/kg. Approximately 320 mosmol/kg (range: ) Sugar Content No sugar GAMUNEX-C does not contain sucrose Maltose (90 mg/ml), no sucrose. None. L-Proline, a nonessential amino acid, is used as a stabilizer. Sodium Content < 5 mm Trace amounts Not more than 30 mmol/l. Trace ph of Product (range is ) Product Half Life 4-week dosing: 34.8 days Approximately 35 days Not tested in primary humoral immunodeficiency (PI) patients Mean 3-week dosing interval = 27.6 ± 5.9 days Mean 4-week dosing interval = 45.4 ± 18.5 days Process Solvent detergent, nanofiltration, terminal low ph incubation GAMUNEX-C is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anionexchange chromatography. Isotonicity is achieved by the addition of glycine. GAMUNEX-C is incubated in the final container (at the low ph of ). Cold-ethanol fractionation, S/D treatment, and ph 4 treatment. ph 4 incubation, 20nm virus filtration, depth filtration; TSE validation and removal Route of Administration Intravenous (IV) Intravenous (IV): CIDP, PI, ITP. Check prescribing information for initial and maintenance infusion rates. Subcutaneous (SC): PI. Initial rate 20 ml/hr/ site. Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. Intravenous (IV) Intravenous (IV) Formulation & Concentration 10% Liquid 10% Liquid 10% Liquid 10% Liquid When stored between 2 C [35.6 F] and 25 C [77 F]), GAMMAPLEX 10% has a shelf life of 36 months. Do not freeze. Keep GAMMAPLEX 10% in its original carton to protect it from light. 36 months at refrigerated temperature 2-8 C (36-46 F). Do not freeze. 6 months at temperatures not to exceed 25 (77 F) anytime during the 36-month shelf life. Do not freeze. Frozen product should not be used. Do not use after expiration date. Store at room temperature up to 25 C (77 F) for up to 36 months, as indicated by the expiration date printed on the outer carton and vial label. Do not freeze. Protect from light. Shelf Life from Date of Manufacture 36 months 36 months. Do not use after the labeled expiration date. 24 months at +2 C to + 8 C (36 F to 46 F) from the date of manufacture. Within the first 12 months of this shelf-life, the product may be stored up to 9 months at +25 C (77 F). 36 months How Supplied 5 g (50 ml), 10 g (100 ml), 20 g (200 ml) 1 g (10 ml), 2.5 g (25 ml), 5 g (50 ml), 10 g (100 ml), 20 g (200 ml), 40 g (400 ml) Supplied in 2 g, 5 g, 10 g or 20 g single use bottles. 5 g (50 ml), 10 g (100 ml), 20 g (200 ml), 40 g (400 ml) DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

4 Intravenous Immune Globulin (5% & Lyophilized) Carimune NF Flebogamma 5% DIF Gammagard S/D (IgA > 1 μg/ml) Gammaplex 5% BPL Octagam 5% Octapharma Primary Immune Deficiency (PID) Acute ITP, Chronic ITP The treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. Treatment of Primary Immunodeficiency (PI) in adults and pediatric patients two years of age or older. Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL). Prevention and/ or control of bleeding in adult Chronic Idiopathic Thrombocytopenic Purpura (ITP) patients. Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. Primary Humoral Immunodeficiency in adults and pediatric patients 2 years of age and older, Chronic Immune Thrombocytopenic Purpura (ITP) Primary humoral immunodeficiency (PI). Contraindicated in patients with selective IgA deficiency, who possess antibody to IgA or hypersensitivity to immunoglobulins. It is contraindicated in patients who have had anaphylactic or severe systemic reactions to human immune globulin. Individuals who have had a history of anaphylactic or severe systemic reactions to the administration of human immune globulin and IgA deficient patients with antibodies to IgA and a history of hypersensitivity. History of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D <1μg/mL IgA in a 5 % solution. History of anaphylactic or severe systemic reactions to human immunoglobulin; IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hereditary intolerance to fructose, also in infants and neonates for whom sucrose or fructose tolerance has not been established. Anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies against IgA and a history of hypersensitivity. Patients with acute hypersensitivity reaction to corn. IgA Content Specification limit for IgA in Carimune NF is 2.4 g/l Contains trace amounts of IgA (typically less than 50 μg/ml). Average: 2.9 μg/ml IgA concentration less than 1 μg/ml IgA content less than 10 mcg/ml Trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). Osmolality In sterile water: 3% mosm/kg; 6% mosm/ kg; 9% mosm/kg; 12% mosm/kg. In 0.9% NaCl: 3% mosm/kg 6% mosm/kg; 9% mosm/kg; 12% mosm/kg. In 5% Dextrose: 3% mosm/kg 6% mosm/kg; 9% mosm/kg; 12% mosm/kg mosm/kg Information not provided Not less than 240 (typically mosmol/kg) mosmol/kg. Sugar Content 1.67 g sucrose per gram of protein 5% D-sorbitol (polyol) 20 mg/ml glucose in a 5% solution D-sorbitol and glycine Maltose (100 mg/ml), no sucrose. Sodium Content <20mg NaCl per gram of protein Trace (< 3.2 mmol/l) The product, after reconstituted to 5% solution, contains a physiological concentration of sodium chloride (approximately 8.5 mg/ml) mmol/l Not more than 30 mmol/l. ph of Product After reconstitution with a neutral unbuffered diluent, the ph is The ph of the solution ranges from 5 to 6. Average: 5.6 ± ± 0.4 in a 5% solution Product Half Life 21 days 3-week dosing interval: 30 ± 9 days; 4-week dosing interval: 32 ± 5 days 37.7 ± 15 days 4-week dosing: 41 ± 14 days 40.7 days in immunodeficient patients. Process ph trace pepsin, nanofiltration, fractionation, depth filtration, TSE reduction The purification process includes cold ethanol fractionation, polyethylene glycol precipitation, ion exchange chromatography, low ph treatment, pasteurization, solvent detergent treatment, and Planova nanofiltration using 20 nanometer (nm) filters. Solvent Detergent Cohn-Oncley cold ethanol fractionation process Cation and anion exchange chromatography Solvent detergent, 20nm filtration, terminal low ph incubation Cold-ethanol fractionation, S/D treatment, and ph 4 treatment. Route of Administration Intravenous (IV) Intravenous (IV) Intravenous (IV) Intravenous (IV) Intravenous (IV) Formulation & Concentration Lyophilized powder 5% Liquid Lyophilized powder 5% Liquid 5% Liquid Store at room temperature not exceeding 30 C (86 F). Room temperature storage: + 2 to + 25 C (36 F to 77 F) Do not freeze. Store at a temperature not to exceed 25 C (77 F) Store between 2-25 C (35-77 F). Do not freeze. Keep GAMMAPLEX 5% in its original carton to protect it from light. Do not freeze. Frozen product should not be used. Do not use after expiration date. Shelf Life from Date of Manufacture 36 months 24 months 24 months 36 months at room temperature as indicated by expiration date printed on label. 24 months at +2 C to + 25 C (36 F to 77 F) from the date of manufacture. How Supplied 6 g, and 12 g vials 0.5 g (10 ml), 2.5 g (50 ml), 5 g (100 ml) 10 g (200 ml) and 20 g (400 ml) 5 g and 10 g 5 g (100mL), 10 g (200mL), 20 g (400mL) 1 g, 2.5 g, 5 g, 10 g or 25 g single use bottles.

5 Subcutaneous Immune Globulin CUVITRU GAMMAGARD LIQUID Gammaked Kedrion Gamunex-C Hizentra HYQVIA Recombinant Human Hyaluronidase Immune Globulin Infusion (Human) 10% CUVITRU is an Immune Globulin Subcutaneous (Human), 20% solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy [MMN]. Gammaked is an immune globulin injection GAMUNEX-C is an immune globulin injection (human), 10% liquid indicated for Intravenous (human), 10% liquid indicated for Intravenous (IV) treatment of: Primary Humoral (IV) treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years of Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic age and older, Idiopathic Thrombocytopenic Purpura (ITP) in adults and children, Chronic Purpura (ITP) in adults and children, Chronic Inflammatory Demyelinating Polyneuropathy Inflammatory Demyelinating Polyneuropathy (CIDP) in adults. Gammaked may also (CIDP) in adults. GAMUNEX-C may also be administered subcutaneously for the be administered subcutaneously for the treatment of PI. treatment of PI. Replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott- Aldrich syndrome, and severe combined immunodeficiencies. HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults Anaphylactic or severe systemic hypersensitivity reactions to subcutaneous administration of Immune Globulin (Human) IgA deficient patients with antibodies against IgA and a history of hypersensitivity. 1. In patients who have had a history of anaphylactic or severe systemic hypersensitivity reaction to the administration of human immune globulin. 2. In IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous use. Gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Gammaked is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. GAMUNEX-C is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Individuals who have had an anaphylactic or severe systemic reactions to human immune globulin or components of Hizentra, such as polysorbate 80. Individuals with hyperprolinemia. IgA-deficient patients with antibodies against IgA and a history of hypersensitivity. History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). IgA deficient patients with antibodies against IgA and a history of hypersensitivity. Known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA. IgA Content Contains trace amounts of IgA (average concentration of 80 mcg/ml). The average immunoglobulin A (IgA) concentration is 37mcg/mL (in a 10% solution). Average 46 mcg/ml Average 46 mcg/ml The IgA concentration in a 20% solution is < 50 mcg/ml N/A The average immunoglobulin A (IgA) concentration is 37 mcg/ml (in a 10% solution). Osmolality milli-osmoles per kilogram mosmol/kg 258 mosmol/kg 258 mosmol/kg 380mOsm/kg 290 to 350 mosm/kg mosmol/kg Sugar Content No added sugars No sugar added Gammaked does not contain sucrose GAMUNEX-C does not contain sucrose No added sugars No added sugars No added sugars Sodium Content No sodium added No sodium added Trace amounts Trace amounts Trace amounts 8.5 mg/ml No sodium added ph of Product 4.6 to Processes Solvent/detergent (S/D) treatment, 35 nm nanofiltration, and a low ph incubation at elevated temperature (30 C to 32 C). Solvent Detergent, 35 nm filtration, incubation (elevated temp) at low ph Gammaked is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anionexchange chromatography. Isotonicity is achieved by the addition of glycine. Gammaked is incubated in the final container (at the low ph of ). GAMUNEX-C is made from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration, and anion-exchange chromatography. Isotonicity is achieved by the addition of glycine. GAMUNEX-C is incubated in the final container (at the low ph of ). ph 4.0 incubation; 20nm virus filtration, depth filtration; TSE validation and removal Comprehensive virus testing at the Master Cell Bank, Working Cell Bank, and bulk harvest stage Effective virus reduction during the purification process Use of pharmaceutical grade human albumin S/D treatment 35 nm filtration Incubation at low ph Formulation & Concentration 20% Liquid 10% Liquid 10% Liquid 10% Liquid 20% Liquid 10% Liquid Store at 2 C to 8 C [36 F to 46 F] for up to 36 months or Room temperature (not to exceed 25 C [77 F]) for up to 12 months. Do not return CUVITRU to the refrigerator if you take it out to room temperature. Do not freeze. Do not shake. Keep the vials in the carton in order to protect from light. Discard any unused product. Do not use past the expiration date Do not freeze. Store GAMMAGARD LIQUID in the refrigerator or at room temperature Refrigeration: 2 to 8 C [36 to 46 F] for up to 36 months. Room Temperature: up to 25 C [77 F] for up to 24 months. Expiration dates for both storage conditions are printed on the outer carton and vial label. Do not use past the applicable expiration date. 36 months at refrigerated temperature 2-8 C (36-46 F). Do not freeze. 6 months at temperatures not to exceed 25 C (77 F) anytime during the 36-month shelf life. 36 months at refrigerated temperature 2-8 C (36-46 F). Do not freeze. 6 months at temperatures not to exceed 25 C (77 F) anytime during the 36-month shelf life. Stable when stored up at room temperature up to 25 C (77 F) for 30 months. Do not freeze. Protect from light. Do not freeze. Keep the vials in the carton in order to protect from light. Refrigeration: 2 to 8 C [36 to 46 F] for up to 36 months. Room Temperature: up to 25 C [77 F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg. date) printed on the carton. HYQVIA must be used within 3 months after removal to room temperature but within the expiration date on the carton and vial label. Do not return HYQVIA to the refrigerator after it has been stored at room temperature. Shelf Life from Date of Manufacture Up to 36 months when refrigerated. Up to 12 months at room temperature. 24 months at room temperature, 36 months when refrigerated, or until expiration date 36 months. Do not use after the labeled expiration date. 36 months. Do not use after the labeled expiration date. 30 months room temperature Refrigeration: 2 to 8 C [36 to 46 F] for up to 36 months. Room Temperature: up to 25 C [77 F] for up to 3 months during the first 24 months from the date of manufacturing. How Supplied Single use vials 1 g (5mL), 2 g (10mL), 4 g (20mL), 8 g (40mL) Vial 1.0 g, 2.5 g, 5 g, 10 g, 20 g, 30 g Vial 1 g (10 ml), 2.5 g (25 ml), 5 g (50 ml), 10 g (100 ml), 20 g (200 ml) Vial 1 g (10 ml), 2.5 g (25 ml), 5 g (50 ml), 10 g (100 ml), 20 g (200 ml) 40 g (400 ml) Single use, tamper evident vial 1 g (5 ml), 2 g (10 ml), 4 g (20 ml) and 10 g (50 ml) 1.25 ml (200 units), 2.5 ml (400 units), 5.0 ml (800 units), 10.0 ml (1600 units), 15.0 ml (2400 units) Dual vial unit of two single use vials 25 ml (2.5 g), 50 ml (5.0 g), 100 ml (10.0 g), 200 ml (20.0 g), 300 ml (30 g) DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

6 What could simplified dosing mean for your patients on ELOCTATE? Potential to dose with a single vial* Same reconstitution process, fewer vials Less space needed for storage 10 dosage strengths available Now with 4000-, 5000-, and 6000-IU-strength vials, ELOCTATE offers the potential for single-vial dosing Graphic is for illustrative purposes only. *Dosing and frequency may vary based on individual patient response. and Important Safety Information ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Limitation of Use ELOCTATE is not indicated for the treatment of von Willebrand disease. CONTRAINDICATIONS: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients. WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained. ADVERSE REACTIONS: The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash. Please see enclosed Full Prescribing Information. Visit ELOCTATEpro.com for more information 2018 Bioverativ. All rights reserved. ELO-US /18

7 Recombinant Factor VIII (Page 1 of 2) ADVATE ADYNOVATE AFSTYLA TM ELOCTATE TM Bioverativ Helixate FS Indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: Control and prevention of bleeding episodes. Perioperative management. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ADVATE is not indicated for the treatment of von Willebrand disease. ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for: On-demand treatment and control of bleeding episodes Routine prophylaxis to reduce the frequency of bleeding episodes ADYNOVATE is not indicated for the treatment of von Willebrand disease AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes Routine prophylaxis to reduce the frequency of bleeding episodes Perioperative management of bleeding. AFSTYLA is not indicated for the treatment of von Willebrand disease. In adults and children with Hemophilia A (congenital Factor VIII deficiency) for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease. On-demand treatment and control of bleeding episodes in adults and children with hemophilia A; Perioperative management of bleeding episodes in adults and children with hemophilia A; and Routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hemophilia A and reduce the risk of joint damage in children without pre-existing joint damage. Helixate FS is not indicated for the treatment of von Willebrand disease. ADVATE is contraindicated in patients who have lifethreatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80). Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins. Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE or excipients of ELOCTATE (sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20). Do not use in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product. Nutrient in Cell Culture ADVATE is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but does not contain plasma or albumin. The CHO cell line employed in the production of ADVATE is derived from that used in the biosynthesis of RECOMBINATE. The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins. No human or animal derived proteins are used in the purification or formulation processes. BDD-rFVIIIFc is produced by recombinant DNA technology from a human embryonic kidney (HEK) cell line, which has been extensively characterized. The HEK cell line expresses BDDrFVIIIFc into a defined, cell culture medium that does not contain any proteins derived from animal or human sources. The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Stabilizer in Final Formulation Mannitol, trehalose, sodium, histidine, Tris, calcium chloride, polysorbate-80, glutathione Tris (hydroxymethyl) aminomethane, Calcium Chloride, Mannitol, Sodium Chloride, Trehalose Dihydrate, Glutathione, Histidine, Polysorbate. There are no additives of human or animal origin. The reconstituted product contains the excipients: L-Histidine, polysorbate 80, calcium chloride, sodium chloride, sucrose, water for injection. The reconstituted product contains the excipients: sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20. Sucrose ( %), Glycine (21-25 mg/ml), and Histidine (18-23 mm/l) in 250 IU, 500 IU, 1,000 IU Sucrose ( %), Glycine (20-24 mg/ml and Histidine (17-22 mm/l) in 2000 IU, 3000 IU Processes Immunoaffinity chromatography. Solvent/Detergent Treatment. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues. AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. BDD-rFVIIIFc is purified using a series of chromatography steps, including affinity capture with a recombinant, single chain antibody fragment produced in a yeast expression system. No human or animal derived proteins are used in the purification or formulation processes. The production process also incorporates two dedicated viral clearance steps - a detergent treatment step for inactivation and a 15 nm filtration step for removal of viruses. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Product Half Life Adults >16 years: 12.0 ± 4.2, infants 8.7 ± 1.4, 2 to < 5 year olds: 9.5 ± 1.8, 5 to <12 year olds ± 3.5, 12 to <16 year olds 12.0 ± to <18 years; ± years; ± to <6 years: 10.4 (28.7) 6 to <12 years: 10.2 (19.4) 12 to <18 years: 14.3 (33.3) 18 years: 14.2 (26.0) Adults: 19.7 (17.4, 22.0) years: 16.4 (14.1, 18.6) 6-11 years: 14.9 (12.0, 17.8) 1-5 years: 12.7 (11.2, 14.1) Adults: ± 1.82 hours Children: 10.7 hours ( ) Product Recovery Percentage Recovery IU/dL/IU/kg in vivo adults: 2.6 ± 0.5, IU/dL/IU/kg infants: 2.1 ± to <5 years 1.8 ± 0.4, 5 to <12 years 2.1 ± 0.6, 12 to <16 years 2.1 ± to <18 years; 2.12 ± years; 2.66 ± to <6 years: 1.6 (21.1) 6 to <12 years: 1.66 (19.7) 12 to <18 years: 1.69 (24.8) 18 years: 2.00 (20.8) Adults: 2.26 (2.13, 2.40) IU/dL per IU/kg years: 1.85 (1.58, 2.12) IU/dL per IU/kg 6-11 years: 2.44 (2.07, 2.80) IU/dL per IU/kg 1-5 years: 1.92 (1.80, 2.04) IU/dL per IU/kg Adults: 2.20 ± 0.34 IU/dL/IU/kg Children: 1.9 ( ) IU/dL/IU/kg 2-8 C (36-46 F). May be stored at room temperature, up to 30 C (86 F) for up to 6 months not to exceed the expiration date. Do not freeze. Store ADYNOVATE in powder form at 2 to 8 C (36 to 46 F). Do not freeze. ADYNOVATE may be stored at room temperature not to exceed 30 C (86 F) for a period of up to 1 month not to exceed the expiration date. If stored at room temperature, write the date on the carton when ADYNOVATE is removed from refrigeration. After storage at room temperature, do not return the product to the refrigerator. Do not use beyond expiration date printed on the carton or housing. Store ADYNOVATE in the original box and protect from extreme exposure to light. Administer ADYNOVATE as soon as possible, but no later than 3 hours after reconstitution. Do not refrigerate after reconstitution Store AFSTYLA in the original package to protect the AFSTYLA vials from light. Store AFSTYLA in powder form at 2 C to 8 C (36 F to 46 F). Do not freeze to avoid damage to the diluent vial. AFSTYLA can be stored at room temperature, not to exceed 25 C (77 F), for a single period of up to 3 months, within the expiration date printed on the carton and vial labels. Record the starting date of room temperature on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 3 months, or after the expiration date on the product vial, whichever is earlier. Do not use AFSTYLA after the expiration date indicated on the vial. The reconstituted product (after mixing dry product with diluent) can be stored at2 C to 8 C (36 F to 46 F), or at room temperature, not to exceed 25 C (77 F), for up to 4 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 4 hours, it must be discarded. Do not use AFSTYLA if the reconstituted solution is cloudy or has particulate matter. Discard any unused AFSTYLA. Prior to Reconstitution: Store ELOCTATE in the original package to protect the ELOCTATE vials from light. Store ELOCTATE in powder form at 2 C to 8 C (36 F to 46 F). Do not freeze to avoid damage to the pre-filled diluent syringe. ELOCTATE may be stored at room temperature, not to exceed 30 C (86 F), for a single period of up to 6 months, within the expiration date printed on the label. If stored at room temperature, record the date that ELOCTATE is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator. Do not use beyond the expiration date printed on the vial or 6 months after the date that was written on the carton, whichever is earlier. After Reconstitution: The reconstituted product may be stored at room temperature, not to exceed 30 C (86 F), for up to 3 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 3 hours, it must be discarded. Do not use ELOCTATE if the reconstituted solution is cloudy or has particulate matter. Discard any unused ELOCTATE. Store in refrigerator at 2-8 C (36-46 F) for up to 30 months from the date of manufacture. Within this period, Helixate FS may be stored for a period of up to 12 months at temperatures up to +25 C (77 F). Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Do not use Helixate FS after the expiration date indicated on the vial. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use. Shelf Life from Date of Manufacture 24 months 24 months 36 months 36 months from date of manufacture 30 months under refrigeration, shelf-life expires after storage at room temperature, or after the expiration date on the vial, whichever is earlier. How Supplied / Diluent Volume 2 ml, 5 ml 5 ml 250, 500, 1000 IU in 2.5mL or 2000 IU, 3000 IU in 5mL 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 and 6000 IU - all sizes in 3mL 250 IU ml, 500 IU ml, 1,000 IU ml, 2,000 IU - 5 ml, 3,000 IU - 5mL DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

8

9 Recombinant Factor VIII (Page 2 of 2) Kogenate FS Bayer KOVALTRY Bayer Novoeight Novo Nordisk NUWIQ Octapharma Recombinate XYNTHA Pfizer On demand treatment and control of bleeding episodes in adults and children with hemophilia A. Peri-operative management in adults and children with hemophilia A. Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage. Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A. Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. KOVALTRY is not indicated for the treatment of von Willebrand disease Indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for: Control and Prevention of bleeding Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Novoeight is not indicated for the treatment of von Willebrand disease. NUWIQ is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes NUWIQ is not indicated for the treatment of von Willebrand Disease. RECOMBINATE is indicated in Hemophilia A for the prevention and control of hemorrhagic episodes. Also indicated in the perioperative management of patients with Hemophilia A. XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes and for perioperative management. XYNTHA does not contain von Willebrand factor, and therefore is not indicated in von Willebrand's disease. Do not use in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product Do not use in patients who have history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight or its components (including traces of hamster proteins) NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components. In patients who have manifested lifethreatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse, or hamster proteins. Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. Nutrient in Cell Culture The cell culture medium contains human plasma protein solution and recombinant insulin, but does not contain any proteins derived from animal sources. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS Human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes Novoeight is produced using a defined cell culture medium which does not contain any proteins derived from human or animal sources BDD-rFVIII is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) cells with no animal or human derived materials added during the manufacturing process or to the final product. Bovine serum albumin and aprotinin The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources. Stabilizer in Final Formulation Sucrose: % (250 IU, 500 IU, 1,000 IU); % (2,000 IU, 3,000 IU) Glycine: mg/ml (250 IU, 500 IU, 1,000 IU); mg/ml (2,000 IU, 3,000 IU) Histidine: mmol/l(250 IU, 500 IU, 1,000 IU); mmol/l (2,000 IU, 3,000 IU) 2.2% glycine, 1% sucrose, 30 mm sodium chloride, 2.5 mm calcium chloride, 20 mm histidine and 80 ppm polysorbate mg/ml sodium chloride, 1.5 mg/ml L-histidine, 3 mg/ ml sucrose, 0.1 mg/ml polysorbate 80, mg/ml L-methionine, 0.25 mg/ml calcium chloride dihydrate The reconstituted product contains the following excipients per ml: 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate, 1.2 mg poloxamer 188, and 1.2 mg sodium citrate dihydrate. Human albumin, calcium, polyethylene glycol, sodium, histidine, polysorbate 80. Sucrose Processes The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates. The production process includes two dedicated viral clearance steps: A detergent treatment step for inactivation A 20 nm filtration step for removal of viruses The active substance is concentrated and purified by a series of chromatography steps, which also includes two dedicated viral clearance steps: solvent/detergent (S/D) treatment for virus inactivation and 20 nm nanofiltration for removal of viruses. Immunoaffinity chromatography The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand. The process also includes a solvent-detergent viral inactivation step and a virusretaining nanofiltration step. Product Half Life ± 1.82 hours 0 to <6 yrs : 12.1 ± 2.7 hours 6 to <12 yrs: 12.0 ± 2.1 hours 12 to 17 yrs: 14.4 ± 5.5 hours 18 yrs: 14.2 ± 3.5 hours Adults/adolescents with hemophilia A: hours Children with hemophilia A: hours In adults: In children 2 to 5 years: In children 6 to 12 years: ± 4.9 hours Adults and Adolescents ( 12 years): hours (initial visit); 11.8 ± 6.2 (month 6); 16.7 ± 5.4 (pre-surgery Adolescents (14-15 years): 6.9 ± 2.4h Children (3.7 years to 5.8 years): 8.3 ± 2.7h Product Recovery Percentage 2.20 ± 0.34 Product as Packaged for Sale: Store Kogenate FS at +2 C to +8 C (36 F to 46 F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25 C or 77 F. The starting date of room temperature storage should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earlier. Do not use Kogenate FS after the expiration date indicated on the vial. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use. Product After Reconstitution: Administer Kogenate FS within 3 hours after reconstitution. It is recommended to use the administration set provided. 0 to <6 yrs; 1.6 (IU/dL)/(IU/kg) 6 to 12 yrs; 1.7 (IU/dL)/(IU/kg) 12 yrs; 2.3 (IU/dL)/(IU/kg) Store KOVALTRY at +2 C to +8 C (36 F to 46 F) for up to 30 months from the date of manufacture. Do not freeze. Within this period, KOVALTRY may be stored for a single period of up to 12 months at temperatures up to +25 C or 77 FRecord the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Do not use KOVALTRY after the expiration date indicated on the vial. Protect KOVALTRY from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use. Adults/adolescents with hemophilia A: (IU/mL per IU/kg) Children with hemophilia A: (IU/mL per IU/kg) Store Novoeight in the original package to protect from light. Store under refrigeration at a temperature of F (2-8 C) for up to 30 months from the date of manufacture until the expiration date stated on the label. Within the 30-month period, Novoeight may also be stored at room temperature not to exceed 86 F (30 C) for up to 12 months. When stored at room temperature, clearly record the date when product was removed from the refrigerator in the space provided on the outer carton. Total storage time at room temperature should not exceed 12 months. Do not return the product to the refrigerator. Do not use Novoeight after the end of the 12-month period at room temperature storage, or after the expiration date stated on the vial, whichever occurs earlier. Do not freeze Novoeight. Use Novoeight within 4 hours after reconstitution when stored at room temperature. Store reconstituted product in the vial. Discard any unused reconstituted product stored at room temperature for more than 4 hours. In adults: In children 2 to 5 years: In children 6 to 12 years: Store NUWIQ in the original package to protect the NUWIQ vials from light. Store in powder form at 2 8 C (35 46 F) for up to 24 months. Do not freeze. During the shelf life, the product may be kept at room temperature [up to 25 C (77 F)] for a single period not exceeding 3 months. After storage at room temperature, do not return the product to the refrigerator. Do not use after the expiration date. Keep the reconstituted solution at room temperature. Do not refrigerate after reconstitution. Use the reconstituted solution immediately or within 3 hours after reconstitution. Discard any remaining solution. Calculated ratio of actual to expected recovery; ± 48.9%. Actual baseline recovery observed was ± 47.7 IU/dL. RECOMBINATE can be refrigerated [2-8 C (36-46 F)] or stored at room temperature, not to exceed 30 C (86 F). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box. Adults and Adolescents ( 12 years): 2.15 ± 0.44 IU/dL per IU/kg (initial visit); 2.47 ± 0.84 (month 6); 2.17 ± 0.47 (pre-surgery) Adolescents (14-15 years): 1.95 ± 0.41IU/dL per IU/kg Children (3.7 years to 5.8 years): 1.52 ± 0.69 IU/dL per IU/kg XYNTHA: Store XYNTHA under refrigeration at a temperature of 2 to 8 C (36 to 46 F) for up to 36 months from the date of manufacture until the expiration date stated on the label. XYNTHA may also be stored at room temperature not to exceed 25 C (77 F) for up to 3 months. After room temperature storage, XYNTHA can be returned to the refrigerator until the expiration date. Do not store XYNTHA at room temperature and return it to the refrigerator more than once. Clearly record the starting date at room temperature storage in the space provided on the outer carton. At the end of the 3-month period, immediately use, discard, or return the product to refrigerated storage. The diluent syringe may be stored at 2 to 25 C (36 to 77 F). Do not freeze, to prevent damage to the pre-filled syringe. During storage, avoid prolonged exposure of XYNTHA to light. XYNTHA SOLOFUSE: Store XYNTHA SOLOFUSE under refrigeration at a temperature of 2 to 8 C (36 to 46 F) for up to 36 months from the date of manufacture until the expiration date stated on the label. Within the expiration date, XYNTHA SOLOFUSE also may be stored at room temperature not to exceed 25 C (77 F) for up to 3 months. Clearly record the starting date at room temperature storage in the space provided on the outer carton. At the end of the 3-month period, immediately use or discard the product. Do not put the product back into the refrigerator. Shelf Life from Date of Manufacture 30 months 30 months 30 months under refrigeration (may also be stored at room temperature not to exceed 86 F (30 C) for up to twelve (12) months) 24 months 36 months Shelf life for both vial and Dual Chamber Syringe presentations are 36 months at the recommended storage conditions. How Supplied / Diluent Volume 250 IU ml, 500 IU ml, 1,000 IU ml, 2,000 IU - 5 ml, 3,000 IU - 5 ml 250 IU - 2.5mL, 500 IU - 2.5mL, 1000 IU - 2.5mL, 2000 IU - 5mL, 3000 IU - 5mL 4mL (250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU vials) The diluent for reconstitution of Novoeight is 0.9% sodium chloride solution and is supplied as a clear colorless solution in a pre-filled diluent syringe. 250, 500, 1000, 2000, 2500, 3000, 4000 IU; Pre-filled syringe with 2.5mL diluent (WFI) 5 ml 250 IU - 4 ml, 500 IU - 4 ml, 1,000 IU - 4 ml, 2,000 IU - 4 ml, 3,000 IU - 4 ml DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

10 All rights reserved December 2017 US/A8/1215/0122(1)

11 Plasma-Derived Factor VIII Alphanate HEMOFIL M Humate-P KOATE Kedrion Monoclate-P Alphanate is indicated for: Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. The use of HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand s disease. Prevention and treatment of bleeding in adult patients with Hemophilia A. Also indicated for adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced bleeding episodes and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis treatment of spontaneous bleeding episodes in VWD. KOĀTE is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A. Treatment of hemophilia A Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components. HEMOFIL M is contraindicated in patients with a known hypersensitivity to the active substance, to excipients, or to mouse proteins. Individuals who have had an anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Do not use in patients who have known hypersensitivity reactions, including anaphylaxis, to KOĀTE or its components. Known hypersensitivity to mouse protein Source Plasma Alphanate is manufactured using source plasma from qualified adult donors who are thoroughly screened and tested. Using the National Donor Deferral Registry (NDDR), previously rejected applicants will not be allowed to donate. Each source plasma donation undergoes a minimum 60- day inventory hold. When the inventory hold period is over, each donation is computer verified. Plasma is then pooled for production and tested again for HIV, HAV, HBV, HCV and PVB19. Repeating the viral testing for both individual donations and the production pools guarantees that each plasma donation has met all safety controls. Human Cold insoluble fraction of pooled human plasma KOĀTE is made from human plasma donated at centers within the US. Pooled human plasma Processes Affinity Chromatography, 3.5% PEG precipitation, salt/glycine precipitation, and lyophilization. Solvent/Detergent Treatment and Heat Treatment at 80 for 72 hrs. Manufacturing process includes steps that provide a reasonable assurance that low levels of a vcjd model agent, if present in the starting material, would be removed. Immunoaffinity Chromatography, Ion Exchange Chromatography, Nanofiltration. Solvent/Detergent Treatment Cryoprecipitation and Al(OH)3 adsorption, glycine precipitation and NaCl precipitation, studied in combination. Heat treatment in aqueous solution at 60 C for 10 hours. Lyophilization The KOĀTE manufacturing process includes two dedicated steps with virus inactivation capacity. The solvent/detergent treatment step has the capacity to inactivate enveloped viruses (such as HIV, HCV, HBV, and WNV). Heat treatment at 80 C for 72 hours has the capacity to inactivate enveloped viruses (such as HIV and HCV) as well as nonenveloped viruses (such as HAV and B19V). The polyethylene glycol (PEG) precipitation/depth filtration step has the capacity to remove both enveloped and nonenveloped viruses. The manufacturing process has been shown to decrease TSE infectivity of that experimental model agent (a total of 5.1 log10 reduction), providing reasonable assurance that low levels of vcjd/cjd agent infectivity, if present in the starting material, would be removed. Monoclonal Antibody Immunoaffinity Chromatography. Pasteurization by heating at 60 C for 10 hours in aqueous solution Product Half Life 17.9 ± 9.6 hours in hemophilia A patients 7.67 ± 3.3 hours for VWF:RCo in VWD patients 21.6 ± 7.8 hours for FVIII:C in VWD patients 14.8 ± 3.0 hours Hemophilia A: Mean half-life of 12.2 hours ( ) VWF:RCo 11 hours ( ) Mean biologic half-life was 16.1 hours. Mean half-life of 17.5 hours Product Recovery Percentage 96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients 3.3 ± 1.5 (IU/dL)/(IU/kg) for VWF:RCo in VWD patients 2.1 ± 0.6 (IU/dL)/(IU/kg) for FVIII:C in VWD patients Approximately 2.0 iu/dl per infused iu/kg body weight 2 IU/dL/IU/kg Each vial of KOĀTE is labeled with the actual Factor VIII potency in international units (IU). Calculation of the required dose of Factor VIII activity is approximately 2% 1.9 IU/dL/IU/kg Presence of von Willebrand Factor Yes No Yes, VWF:Rco to FVIII ratio: 2.4:1 Yes, but NOT indicated for Von Willebrand Disease Reduced amounts of VWF:Ag Room temperature storage for 36 months, up to expiration date printed 25 C (77 F). Do not Freeze. Refrigeration 2-8 C (36-46 F) or room temperature, not to exceed 30 C or 86 F until expiration date noted on package. When stored up to 25 C (up to 77 F), Humate-P is stable up to the expiration printed on the label. Do not freeze. Store the KOĀTE package at 2 to 8 C (36 to 46 F). KOĀTE may be stored at room temperature (up to 25 C or 77 F) for up to 6 months Store in refrigerator, 2-8 C (36-46 F) through expiration date on label. Within this period, Monoclate-P may be stored at room temperature, not to exceed 25 C (77 F), for up to 6 months. Avoid freezing which may damage container for the diluent. Shelf Life from Date of Manufacture Stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 C (77 F). 30 months 36 months Approximately 24 months. Do not use KOĀTE after the labeled expiration date. 24 months How Supplied / Diluent Volume 5mL for 250 and 500 IU 10mL for 1000, 1500, and 2000 IU 10 ml 600 IU VWF:Rco and 250 IU FVIII/vial - 5 ml, 1,200 IU VWF:Rco and 500 IU FVIII/vial - 10 ml, 2,400 IU VWF:Rco and 1000 IU FVIII/vial - 15 ml 250 IU - 5mL, 500IU - 5mL and 1000mL 10IU with Mix2Vial 250 IU ml, 500 IU - 5 ml, 1,000 IU - 10 ml, 1,500 IU - 10 ml DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

12 Rebinyn elevates factor levels above baseline levels 1,a +94 % FIX levels achieved immediately after an infusion 1,b b Based upon a 2.34% increase in factor levels per IU/kg infused in adults. 17 % after 7 days 1,a FIX levels sustained a Based upon a single initial dose of Rebinyn 40 IU/kg in 6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children ages 7 to 12 (mean FIX activity 10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using one-stage assay with product-specific standard. With a single dose of Rebinyn 40 IU/kg in adults with 2% factor levels 1,a Clayton, 34 years old, is a pilot who hikes and camps in his spare time. Clayton lives with hemophilia B. Image of hemophilia B patient shown is for illustrative purposes only. INDICATIONS AND USAGE Rebinyn, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for on demand treatment and control of bleeding episodes and perioperative management of bleeding. Limitations of Use: Rebinyn is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B. IMPORTANT SAFETY INFORMATION Rebinyn is contraindicated in patients with a known hypersensitivity to Rebinyn or its components, including hamster proteins. Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn if allergic or anaphylactic-type reactions occur and initiate appropriate treatment. Development of neutralizing antibodies (inhibitors) to Factor IX may occur. Monitor patients for development of factor IX inhibitors if bleeding is not controlled with the recommended dose of Rebinyn or if expected Factor IX activity plasma levels are not attained. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used. The use of Factor IX-containing products has been associated with thrombotic complications. Monitor for thrombotic and consumptive coagulopathy when administering Rebinyn to patients with liver disease, post-operatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation (DIC). Nephrotic syndrome has been reported following immune tolerance induction therapy with Factor IX products in hemophilia B patients with Factor IX inhibitors, often with a history of allergic reactions to Factor IX. The safety and efficacy of using Rebinyn for immune tolerance induction have not been established. Adverse Reactions The most common adverse reactions reported in clinical trials ( 1%) were itching and injection site reactions. Animals administered repeat doses of Rebinyn showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown. Please see the Rebinyn Prescribing Information in the pocket. Reference: 1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May Learn more at rebinynpro.com Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey U.S.A. Rebinyn is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S Novo Nordisk All rights reserved. USA17BIO04152 January 2018

13 Recombinant Factor IX ALPROLIX Bioverativ BeneFIX Pfizer IDELVION IXINITY Aptevo Rebinyn Novo Nordisk RIXUBIS ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, coagulation factor IX concentrate indicated in adults and children with Hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. ALPROLIX is not indicated for induction of immune tolerance in patients with Hemophilia B. BeneFIX, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of hemorrhagic episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including management of hemostasis in surgical settings. Children and adults with hemophilia B (congenital Factor IX deficiency) for: On-demand control and prevention of bleeding episodes Perioperative management of bleeding Routine prophylaxis to prevent or reduce the frequency of bleeding episodes IDELVION is not indicated for immune tolerance induction in patients with hemophilia B. Adults and children at least 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management Adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Limitations of Use: Rebinyn is not indicated for routine prophylaxis in the treatment of patients with hemophilia B. Rebinyn is not indicated for immune tolerance induction in patients with hemophilia B Indicated in adults and children with hemophilia B for: Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis. RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B. Do not use in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients. Because BeneFIX, Coagulation Factor IX (Recombinant), is produced in a Chinese hamster ovary cell line, it may be contraindicated in patients with a known history of hypersensitivity to hamster protein. BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components. Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins. Hypersensitivity to IXINITY or its excipients, including hamster protein Do not use in patients who have known hypersensitivity to Rebinyn or its components, including hamster proteins Do not use in patients with: Known hypersensitivity to RIXUBIS or its excipients including hamster protein. Disseminated intravascular coagulation. Signs of fibrinolysis Processes To enhance viral safety, the purification process incorporates a nanofiltration step and a column chromatography purification step that have been validated for viral clearance. The content of activated Factor IX Fc fusion protein (FIXaFc) is limited to mole percent FIXaFc/FIXFc. Purified by a chromatography purification process that does not require a monoclonal antibody step and yields a high-purity, active product. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 (such as large proteins and viral particles). The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration. Purified by a chromatography purification process that includes three validated steps for virus inactivation and removal - solvent/detergent treatment, a chromatographic step, and nanofiltration. The manufacturing process also includes a validated step to reduce the presence of CHO proteins in the final drug product. The production process includes two dedicated viral clearance steps: A detergent treatment step for inactivation A 20 nm filtration step for removal of viruses 15 nm Nanofiltration. Solvent/Detergent Treatment. Product Half Life Adults: 12 to 17 years: 6 to <12 years: <6 years: 50 IU/kg 86 (37%) 80 (15%) 72 (23%) 68 (24%) 100 IU/kg 97 (35%) 94 (24%) Adults and Adolescents (>15 years): 18.8 ± 5.4h Adolescents ( 12 years to 15 years): 21.1 ± 4.5h Children ( 2 years to <12 years): 19.8 ± 4.0h 0 to <6 years: 90 (CV 13%) hours 6 to <12 years: 93 (CV 21%) hours 12 to <18 years: 87 (CV 36%) hours 18 years: 104 (CV 25%) hours (50 IU/kg dose) Terminal Half-life (hours) 24 (± 7) 0-6 years: 69.6 hours 7-12 years: 76.3 hours years: 89.4 hours > 18 years: 83.0 hours Mean 1/2 life after 1st dose 26.7 Product Recovery Percentage Adults: 12 to 17 years: 6 to <12 years: <6 years: 50 IU/kg 1.02 (59%) 0.87 (44%) 0.74 (29%) 0.60 (20%) 100 IU/kg 1.12 (22%) 0.96 (10%) Mean increase from pre-infusion level: Adults and Adolescents (>15 years): 0.8 ± 0.2 IU/dL per IU/kg Adolescents ( 12 years to 15 years): 0.8 ± 0.3 IU/dL per IU/kg Children ( 2 years to <12 years): 0.7 ± 0.2 IU/dL per IU/kg Incremental recovery recorded 30 minutes after injection: 0 to <6 years:.95 IU/dL per IU/kg 6 to <12 years: 1.06 IU/dL per IU/kg 12 to <18 years: 1.11 IU/dL per IU/kg Mean recovery, 0.98 IU/dL per IU/kg Incremental recovery recorded 30 minutes after injection: 0-6 years: 1.51 IU/dL per IU/kg 7-12 years: 1.59 IU/dL per IU/kg years: 1.96 IU/dL per IU/kg > 18 years: 2.34 IU/dL per IU/kg Mean incremental recovery in ([IU/dL]/[IU/kg]) 0.67 (± 0.16) Store ALPROLIX in the original package in order to protect it from light. Store ALPROLIX at 2 C to 8 C (36 F to 46 F). ALPROLIX may also be stored at room temperature, not to exceed 30 C (86 F) for a single 6 month period. On the carton, record the date when the product was removed from refrigeration. Use the product before the end of this 6 month period or discard it. Do not place the product back into refrigeration after warming to room temperature. Do not freeze. Freezing will damage the pre-filled diluent syringe. Do not use product or diluent after the expiration date printed on the carton, vial or syringe. Reconstituted product may be stored at room temperature, not to exceed 30 C (86 F) for no longer than 3 hours. Protect from direct sunlight. Discard any product not used within 3 hours after reconstitution. For products labeled for Room Temperature, store at 2-30 C (not to exceed 30 C). Room Temperature labeled BeneFIX may also be stored under refrigeration (2 to 8 C or 36 to 46ºF). For products labeled for Refrigerated, store at 2-8 C, prior to expiration date. Refrigerated labeled BeneFIX may also be stored at room temperature not to exceed 30 C (86 F) for up to 6 months. Freezing should be avoided to prevent damage to the diluent syringe. Do not use BeneFIX after the expiry date on the label. If the product kit labeled for refrigerated storage has been removed from refrigeration and stored at room temperature (not to exceed 30ºC or 86ºF), the expiration period should be up to 6 months from the date of removal from refrigeration. Do not use the product once this six month period has elapsed even if the expiration date on the carton has not been exceeded. **Refrigerated product is no longer being manufactured or distributed by Pfizer Inc. The last expiration date of the last lot packaged for the US is 3/31/2014. Store IDELVION in its package to protect from light. Store the IDELVION package in the refrigerator or at room temperature 2-25 C (36 to 77 F). Do not freeze. Do not use IDELVION or the Sterilized Water for Injection diluent beyond the expiration date printed on the carton and vial labels. Store product at 2 to 25 degrees C (36 to 77 degrees F). Do not freeze. Infuse reconstituted solution immediately or within 3 hours of storage at room temperature. Do not refrigerate after reconstitution. Store Rebinyn in the original package in order to protect from light. Store Rebinyn under refrigeration at a temperature of 36 F-46 F (2 C 8 C) for up to 24 months from the date of manufacture until the expiration date stated on the label. Rebinyn may be stored at room temperature not to exceed 86 F (30 C) for up to 6 months within the 24-month time period. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator. Do not use Rebinyn after the end of the 6-month period at room temperature storage, or after the expiration date stated on the vial, whichever occurs earlier. Do not freeze Rebinyn. Use Rebinyn within 4 hours after reconstitution when stored at room temperature. Store the reconstituted product in the vial. Discard any unused reconstituted product stored at room temperature for more than 4 hours. Store at refrigerated temperature [2 C to 8 C (36 C to 46 F)] or room temperature [not to exceed 30 C (86 F)] for up to 36 months. Do not freeze. Shelf Life from Date of Manufacture 36 months from the date of manufacture For products labeled for Room Temperature, the shelf life is 24 months when stored at 2-30 C (not to exceed 30 C). For products labeled for Refrigerated, the shelf-life is 36 months when stored at 2-8 C; if stored at room temperature (2-30 C; not to exceed 30 C) prior to the expiration date, then the shelf life becomes 6 months. **Refrigerated product is no longer being manufactured or distributed by Pfizer Inc. The last expiration date of the last lot packaged for the US is 3/31/ months 24 months Under refrigeration: Up to 24 months from the date of manufacture until the expiration date as stated on the label Rebinyn may be stored at room temperature not to exceed 86 F (30 C) for up to 6 months within the 24-month time period. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator or use after the end of the 6-month period. 36 months How Supplied / Diluent Volume 250, 500, 1000, 2000, 3000 & 4000 IU - all sizes in 5mL 5 ml (nominally 250, 500, 1000, 2000, or 3000 IU vials) 2.5mL (250, 500 or 1000 IU vials) or 5mL (2000 IU vials) 5 ml of SWI supplied with each packaged kit 4mL (500 IU, 1000 IU, 2000 IU) The diluent for reconstitution of Rebinyn is histidine and is supplied as a clear colorless solution in a pre-filled diluent syringe. 5 ml DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

14 All rights reserved December 2017 US/A8/1215/0122(1)

15 FVIII / vwf Complex Concentrates (Indicated to treat von Willebrand Disease) Alphanate Humate-P VONVENDI wilate Octapharma Alphanate is indicated for: Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. Prevention and treatment of bleeding in adult patients with Hemophilia A. Also indicated for adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced bleeding episodes and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where use of desmopressin is known or suspected to be inadequate. Humate-P is not indicated for the prophylaxis treatment of spontaneous bleeding episodes in VWD. VONVENDI is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease. WILATE is indicated in children and adults with von Willebrand disease for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Limitations of Use: WILATE is not indicated for the treatment of hemophilia A. Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components. Individuals who have had an anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Do not use in patients who have had life-threatening hypersensitivity reactions to VONVENDI or its components (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and hamster or mouse proteins). WILATE is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation or components of the container Processes 1.2 average ratio. Ratio of VWF:RCo to FVIII varies by lot, so check IU VWF:RCo/vial to ensure accurate dosing. Actual FVIII and VWF:RCo potency is listed on vial label & folding carton for each lot. Cold insoluble fraction of pooled human plasma Administer VONVENDI with recombinant factor VIII if required, to control bleeding. Dosing should be at a ratio of 1.3:1 The VWF:RCo to FVIII:C ratio is 1:1. Product Half Life Affinity Chromatography, 3.5% PEG precipitation, salt/glycine precipitation, and lyophilization. Solvent/Detergent Treatment and Heat Treatment at 80 for 72 hrs. Manufacturing process includes steps that provide a reasonable assurance that low levels of a vcjd model agent, if present in the starting material, would be removed. Cryoprecipitation and Al(OH)3 adsorption, glycine precipitation and NaCl precipitation, studied in combination. Heat treatment in aqueous solution at 60 C for 10 hours Lyophilization VONVENDI is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. Ion-exchange chromatography, Solvent/detergent (S/D) treatment, and terminal dry-heat (TDH) treatment of the lyophilized product in final container [at +100 C (212 F) for 120 minutes at a specified residual moisture level of %]. Product Recovery Percentage 17.9 ± 9.6 hours in hemophilia A patients 7.67 ± 3.3 hours for VWF:RCo in VWD patients 21.6 ± 7.8 hours for FVIII:C in VWD patients Hemophilia A: Mean half-life of 12.2 hours ( ) VWF:RCo 11 hours ( ) Mean half-life of 19.3 hours when infused with ADVATE 15.8 ± 11.0 hours for VWF:RCo, and 19.6 ± 6.9 hours for FVIII:C. Manufacturing Method 96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients 3.3 ± 1.5 (IU/dL)/ (IU/kg) for VWF:RCo in VWD patients 2.1 ± 0.6 (IU/dL)/(IU/kg) for FVIII:C in VWD patients 2 IU/dL/IU/kg ± 0.4 % per IU/kg for VWF:RCo, and 2.2 ± 0.5 % per IU/kg for FVIII:C. Room temperature storage for 36 months, up to expiration date printed 25 C (77 F). Do not freeze. When stored up to 25 C (up to 77 F), Humate-P is stable up to the expiration printed on the label. Do not freeze. Store VONVENDI refrigerated at 2 C to 8 C (36 F to 46 F) in the original box and protect from extreme exposure to light. Do not freeze. May store at room temperature up to 30 C (86 F) for a period of up to 12 months not to exceed the expiration date. Record on the carton the date VONVENDI is removed from refrigeration. Do not return to refrigerated temperature after storing at room temperature. Do not use beyond the expiration date printed on the VONVENDI vial label or carton. Do not freeze. Do not use after expiration date. Shelf Life from Date of Manufacture Stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 C (77 F). 36 months Use up to the expiration date on the label may store for 12 months at room temperature not to exceed 30 C (86 F). 36 months at +2 C to +8 C (36 F to 46 F) protected from light from the date of manufacture. Within this period, Wilate may be stored for a period of up to 6 months at room temperature (maximum of +25 C or 77 F). How Supplied / Diluent Volume 5mL for 250 and 500 IU 10mL for 1000, 1500, and 2000 IU 600 IU VWF:Rco and 250 IU FVIII/vial - 5 ml, 1,200 IU VWF:Rco and 500 IU FVIII/vial - 10 ml, 2,400 IU VWF:Rco and 1000 IU FVIII/vial - 15 ml IU in 5 ml, IU in 10 ml 500 IU VWF:RCo and 500 IU FVIII:C activities in 5 ml, and 1000 IU VWF:RCo and 1000 IU FVIII:C activities in 10 ml DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

16 Plasma-Derived Factor IX AlphaNine SD Bebulin Mononine Profilnine AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII. BEBULIN is indicated for the prevention and control of bleeding episodes in adult patients with hemophilia B (congenital Factor IX deficiency or Christmas disease) BEBULIN is not indicated for use in the treatment of Factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency. Prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease. (factor IX complex) indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). Profilnine contains non-therapeutic levels of factor VII and is not indicated for use in the treatment of factor VII deficiency. None Known BEBULIN is contraindicated in patients with: Known history of hypersensitivity reactions to the product Known allergy to heparin Known history of heparin-induced thrombocytopenia Known hypersensitivity to mouse protein None Known Processes DEAE Chromatography, Dual Affinity Chromatography and Nanofiltration. Solvent/Detergent Treatment with a mixture of Tri (n-butyl) phosphate (TNBP) and Polysorbate nm nanofiltration, DEAE-Sephadex adsorption. Vapor heat treatment process [10 hours at 60 C and subsequent 1 hour at 80 C under the condition of 7-8% (w/v) residual moisture]. Monoclonal antibody immunoaffinity chromatography and nanofiltration DEAE Chromatography and nanofiltration. Solvent/Detergent Treatment with a mixture of Tri (n-butyl)phosphate (TNBP) and Polysorbate 80. Product Half Life 21 hours 19.4 ± 3.8, 24.6 ± 3.2, ± 8.24 hours hours ± 8.29 hours Product Recovery Percentage Approximately 48% 53.3 ± 9.6, 57.7 ± 21.8, ± 16.95% IU/dL/IU/kg 1.15 ± 0.16 IU/dL per IU infused per kg body weight Manufacturing Method Plasma derived Plasma Pooled human plasma Plasma derived 2-8 C (36-46 F), do not freeze diluent. Stable at room temperature not to exceed 30 C for up to 1 month. Store at refrigerated temperature (2 C-8 C, 35 F-46 F). Do not use BEBULIN past the expiration date printed on the unit carton. Do not freeze. When stored at refrigerator temperature, 2-8 C (36-46 F), Mononine is stable for the period indicated by the expiration date on its label. Within this period, Mononine may be stored at room temperature not to exceed 25 C (77 F), for up to one month. Avoid freezing, which may damage container for the diluent. Store at or below 25 C (77 F). Do not freeze. Shelf Life from Date of Manufacture 3 years, up to the date printed on the label, when stored at 2-8 C. 24 months 24 months Stable for three years at room temperature, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 C (77 F). How Supplied / Diluent Volume 10 ml for 500 IU, 1000 IU, 1500 IU 20 ml 500 IU - 5 ml, 1,000 IU - 10 ml 5 ml for 500 IU 10 ml for 1000 & 1500 IU

17 Factors X & XIII Factor X Coagadex BPL Corifact Factor XIII Tretten Novo Nordisk Indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for: On-demand treatment and control of bleeding episodes AND Perioperative management of bleeding in patients with mild hereditary Factor X deficiency. Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency has not been studied. Indicated for adults and pediatric patients with congenital factor XIII deficiency for: 1) routine prophylactic treatment 2) peri-operative management of surgical bleeding Routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency. TRETTEN is not for use in patients with congenital factor XIII B-subunit deficiency COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX or any of the components Patients with known anaphylactic or severe systemic reactions to human plasma-derived products Hypersensitivity to the active substance or to any of the excipients. Processes Solvent/detergent treatment; 15-nm filtration; Terminal dry-heat treatment Precipitation/adsorption Ion exchange chromatography Heat-treatment (+60 C for 10 hours in an aqueous solution) Virus filtration over two 20 nm filters in series Purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography. Product Half Life 30.3 hours 6.6 days ± days Product Recovery Percentage 2.08 N/A N/A Manufacturing Method Manufactured from plasma, obtained from healthy US donors, who have passed viral screening tests. Three processing steps specifically designed to remove or inactivate viruses are: Solvent/detergent treatment targeted to inactivate enveloped viruses; A 15-nm filtration step designed to remove small viruses including non-enveloped viruses; and Terminal dry-heat treatment at 80 C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses. Pooled human plasma Recombinant Coagulation Factor XIII A-Subunit manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pd16. It is subsequently isolated by homogenization of cells and purified by several chromatography steps, including hydrophobic interaction and ion exchange chromatography. Store COAGADEX in its original package to protect it from light. Store the COAGADEX package in a refrigerator or at room temperature (36 F to 86 F). Do not freeze. Use reconstituted COAGADEX within one hour of reconstitution. Refrigerate Corifact at 2-8 C (36-46 F). Keep in original carton to protect from light. Do not freeze. Corifact is stable for 36 months, up to the expiration date on the carton and vial labels. Within the expiration date, Corifact may be stored at room temperature not to exceed 25 C (77 F) for up to 6 months. Do not return the product to the refrigerator after it is stored at room temperature. Clearly mark the beginning date of room temperature storage on the carton label. Do not use beyond the expiration date on the carton and vial labels, or end of the period for room temperature storage, whichever comes first. This product does not contain a preservative and must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Store refrigerated at 2 C 8 C (36 F 46 F) prior to reconstitution. TRETTEN is stable until the expiration date on the carton and vial label. Do not freeze. Store protected from light. Use reconstituted TRETTEN within 3 hours. If the reconstituted product is not used immediately, store the solution refrigerated or at room temperature not to exceed 25 C (77 F) for up to 3 hours following reconstitution Shelf Life from Date of Manufacture 36 months Corifact is stable for 36 months, up to the expiration date on the carton and vial labels. Prior to reconstitution and under refrigeration, Tretten is stable until the expiration date on the carton and vial label. How Supplied / Diluent Volume 250 IU (2.5 ml) or 500 IU (5 ml) IU: 20 ml vial of Sterile Water for Injection The actual amount of TRETTEN in international units (IU) is stated on each carton and vial. TRETTEN and the sterile water vials provided in the package are not made with natural rubber latex. After reconstitution with 3.2 ml of sterile water for injection, each vial contains IU/mL of recombinant coagulation factor XIII A-subunit. DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

18 Peel-off labels for convenient infusion tracking For your patients who have congenital hemophilia A or B with inhibitors (CHwI), it s time to help them Spread their wings and Usage NovoSeven RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for: Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia Important Safety Information WARNING: THROMBOSIS Serious arterial and venous thrombotic events following administration of NovoSeven RT have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. Experience 30 years of research and long-term clinical experience 1,a Effectiveness proven efficacy in bleed control and surgery in 4 conditions 2 Portability room temperature stable for fast access to treatment 2 Speed fast reconstitution and infusion time leading to fast activity 2,3 Safety recombinant safety and a low rate of thrombotic adverse events 2,4,b a Compassionate use, also known as expanded access, began enrolling in 1989; FDA approval received in ,4 b In people with hemophilia A or B with inhibitors Visit NovoSevenRTpro.com today to learn more. Chase, 5 years old, lives with CHwI, and loves anything that has to do with cars, planes, or playing golf. Warnings and Precautions Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance. Exercise caution when administering NovoSeven RT to patients with an increased risk of thromboembolic complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease, post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment with apccs/pccs (activated or nonactivated prothrombin complex concentrates). Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven RT. Administer only if clearly needed in patients with known hypersensitivity to NovoSeven RT, any of its components, or mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven RT and administer appropriate treatment. Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. Laboratory coagulation parameters (PT/INR, aptt, FVII:C) have shown no direct correlation to achieving hemostasis. Adverse Reactions The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia. Drug Interactions Thrombosis may occur if NovoSeven RT is administered concomitantly with Coagulation Factor XIII. Please see the NovoSeven RT Prescribing Information in the pocket. References: 1. Hedner U. History of rfviia therapy. Thromb Res. 2010;125 (suppl 1):S4 S6. 2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Bysted BV, Scharling B, Møller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 C stable formulation. Haemophilia. 2007;13(5): Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia. 2008;14(5): Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey U.S.A. NovoSeven is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S Novo Nordisk All rights reserved. USA17BIO04265 January 2018

19 Additional Coagulation Products Feiba NF Anti-Inhibitor Anti-Inhibitor / Acquired Hemophilia Acquired Hemophilia A Desmopressin Acetate Fibrinogen Concentrate Prothrombin Complex Concentrate HEMLIBRA Genentech NovoSeven RT Novo Nordisk OBIZUR Stimate RiaSTAP Kcentra FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors Congenital Factor VII (FVII) deficiency, and Glanzmann s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets. Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia. Indicated for the treatment of bleeding episodes in adults with acquired hemophilia A Indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5% Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (warfarin reversal) therapy in adult patients with acute major bleeding or the need for an urgent surgery/invasive procedure. Kcentra has a Boxed Warning: Arterial and Venous Thromboembolic Complications History of known anaphylactic or severe hypersensitivity reactions to FEIBA or any if its components, including factors of the kinin generating system. Disseminated intravascular coagulation (DIC). Acute thrombosis or embolism (including myocardial infarction). None There are no known contraindications to NovoSeven RT Do not use in patients who have had lifethreatening hypersensitivity reactions to OBIZUR or its components, including hamster protein. None Contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products Patients with known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, FII, FVII, FIX, FX, Proteins C and S, AT III and Human albumin; patients with DIC; patients with known HIT. Kcentra contains heparin. Processes Vapor Heat Treatment and 35 nm Nanofiltration N/A Chromatographic purification process, demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). The production process includes two dedicated viral clearance steps - a solvent/detergent treatment step for viral inactivation and a nanofiltration step through a series of two 15- nm filters for removal of viruses N/A Cryoprecipitation, Heat treatment, Glycine precipitation (two subsequent steps), and lyophilization Kcentra is manufactured from cryo-depleted plasma that is adsorbed via ion exchange chromatography, heat treated in aqueous solution for 10 hours at 60 C, precipitated, adsorbed to calcium phosphate, virus filtered, and lyophilized. Product Half Life N/A; Dosing intervals: 6-12 hours by type of hemorrhage Following subcutaneous administration, the mean (± SD) absorption half-life was 1.7 ± 1 day. The mean apparent clearance (95% confidence interval [CI]) was 0.24 L/day (0.22, 0.26) and the mean elimination apparent half-life (± SD) was 27.8 ± 8.1 days. Hemophilia A or B: hours Congenital Factor VII deficiency: hours 10 hours mean; range hours hours Mean: hours; Range: hours Terminal half-life; mean (SD): Factor IX = 42.4 (41.6) hours; Factor II = 60.4 (25.5) hours; Factor VII = 5.0 (1.9) hours; Factor X = 31.8 (8.7) hours; Protein C = 49.6 (32.7) hours; Protein S = 50.4 (13.4) hours Product Recovery Percentage N/A Emicizumab-kxwh exhibited dose-proportional pharmacokinetics over a dose range of 0.3 mg/kg (0.1 times approved recommended starting dosage) to 3 mg/kg once weekly following subcutaneous administration. Following multiple subcutaneous administrations of 3 mg/kg once weekly for the first 4 weeks in hemophilia A patients, mean (± SD) trough plasma concentrations of emicizumab-kxwh increased to achieve 54.6 ± 14.3 μg/ml at Week 5. Trough plasma concentrations above 50 μg/ml were sustained thereafter with the recommended weekly dosage of 1.5 mg/kg; the mean (± SD) trough plasma concentrations of emicizumab-kxwh at steady- state was 52.8 ± 13.5 μg/ml. Hemophilia A or B patients: 45.63%. Congenital Factor VII deficiency: 18.9% and 22.2% with 15 and 30 mcg per kg doses respectively. A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours. N/A N/A In Vivo Recovery (%/units/kg bw); mean (SD): Factor IX = 1.6 (0.4); Factor II = 2.2 (0.3); Factor VII = 2.5 (0.4); Factor X = 2.2 (0.4); Protein C = 2.9 (0.3); Protein S = 2.0 (0.3) Manufacturing Method Plasma Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of kda and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. Recombinant OBIZUR is expressed in a genetically engineered baby hamster kidney (BHK) cell line which secretes rpfviii into the cell culture medium. No additives of human or animal origin are used in the formulation of OBIZUR. Synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH) Plasma Plasma Store at room temperature, not to exceed 25 C (77 F). Store in the original package in order to protect from light. Do not freeze. Store HEMLIBRA vials in a refrigerator at 2 C to 8 C (36 F to 46 F) in the original carton to protect from light. Do not freeze. Do not shake. Prior to administration, if needed, unopened vials of HEMLIBRA may be stored out of and then returned to refrigeration. The temperature and total combined time out of refrigeration should not exceed 30 C (86 F) and 7 days (at a temperature below 30 C [86 F]), respectively. Once removed from the vial, discard HEMLIBRA if not used immediately. Discard any unused HEMLIBRA. Prior to reconstitution, keep refrigerated or store between 2 25 C/36 77 F. Do not freeze. Store protected from light. Do not use past the expiration date. After reconstitution, NovoSeven RT may be stored either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven RT or store it in syringes. Store OBIZUR at refrigeration temperature of 2 to 8 C [36 to 46 F]. Do not freeze. Store vials in the original package to protect from light. Do not use beyond the expiration date printed on the carton or vial. Use OBIZUR within 3 hours after reconstitution. Discard any unused reconstituted product if not used within 3 hours after reconstitution. Do not use OBIZUR if the reconstituted solution is cloudy or has particulate matter Store at room temperature not to exceed 25 C (77 F) for the period indicated by the expiration date on the label. Discard six months after being opened. Store bottle in upright position. Store at temperatures of 2-25 C (36-77 F). Do not freeze. Protect from light. Prior to Reconstitution: Kcentra is for single use only. Contains no preservatives. Store Kcentra between 2-25 C (36-77 F), this includes room temperature, not to exceed 25 C (77 F). Do not freeze. Store the vial in the original carton to protect it from light. After Reconstitution: Kcentra must be used within 4 hours following reconstitution. Reconstituted Kcentra can be stored at 2-25 C. If cooled, the solution should be warmed to C prior to administration. Do not freeze. Discard partially used vials." Shelf Life from Date of Manufacture 24 months Patients should not use Hemlibra past the expiration date on the carton or vial label. NovoSeven RT should not be used past the expiration date as noted on the carton and vial label. 24 months Store at room temperature not to exceed 25 C (77 F) for the period indicated by the expiration date on the label. Discard six months after being opened. 60 months 36 months How Supplied / Diluent Volume 500 U, 1,000 U: 20 ml 2,500 U: 20mL or 50 ml HEMLIBRA (emicizumab-kxwh) injection is available as a sterile, preservativefree, colorless to slightly yellow solution in single-dose vials in the following dosage strengths: 30 mg per 1 ml; 30 mg/ml Concentration 60 mg per 0.4 ml; 150 mg/ml Concentration 105 mg per 0.7 ml; 150 mg/ml Concentration 150 mg per 1 ml; 150 mg/ml Concentration A NovoSeven RT with MixPro package contains: 1 vial of NovoSeven RT powder and 1 pre-filled histidine diluent syringe with vial adapter for needleless reconstitution. The specified volume of diluent corresponding to the amount of NovoSeven RT is as follows: 1 mg (1,000 micrograms) vial + 1 ml Histidine diluent in pre-filled syringe 2 mg (2,000 micrograms) vial + 2 ml Histidine diluent in pre-filled syringe 5 mg (5,000 micrograms) vial + 5 ml Histidine diluent in pre-filled syringe 8 mg (8,000 micrograms) vial + 8 ml Histidine diluent in pre-filled syringe. After reconstitution with the specified volume of diluent, each vial contains approximately 1mg/mL NovoSeven RT (1,000 micrograms/ml). 1 ml 2.5 ml bottle with spray pump capable of delivering 25 sprays of 150 mcg Each carton contains one single -use vial of RiaSTAP. The actual potency of fibrinogen concentrate in milligrams (between mg) is stated on each RiaSTAP vial label and carton. Kcentra is supplied in a single-use vial. The actual units of potency of all coagulation factors (Factors II, VII, IX and X), Proteins C and S in units are stated on each Kcentra carton. The Kcentra packaging components are not made with natural rubber latex. Each kit consists of the following: 1) Nominal potency 500 (range ) units Kcentra in a single-use vial; 20 ml vial of Sterile Water for Injection, USP; Mix2Vial filter transfer set; Alcohol swab 2) Nominal potency 1000 (range ) units Kcentra in a single-use vial; 40 ml vial of Sterile Water for Injection, USP; Mix2Vial filter transfer set; Alcohol swab DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information BDI Pharma, LLC. All rights reserved.

20 For life s sensitive moments... TREATMENT SAFETY AND RELIABILITY MATTER TO US. CHOOSE HyperRHO S/D (Rh O [D] immune globulin [human]) HyperRHO S/D Full Dose (Rh O [D] immune globulin [human]) attributes: High titers of specific antibodies for postexposure prophylaxis Mercury (thimerosal) and latex free 4-step virus removal and inactivation process The only Rh O (D) immune globulin product with FDA labeling for prion removal Convenient prefilled syringes for single-use IM injection Needle guards to protect against needle-stick injury Tamper-evident packaging IMPORTANT SAFETY INFORMATION HyperRHO S/D Full Dose (Rh O [D] immune globulin [human]) is indicated for the prevention of Rh hemolytic disease of the newborn (HDN) and the prevention of isoimmunization in Rh O (D)-negative individuals who have been transfused with Rh O (D)-positive red blood cells. Because HyperRHO S/D Full Dose is made from human plasma, it carries a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Never administer HyperRHO S/D Full Dose intravenously. Inject only intramuscularly. Never administer to the neonate. Rh O (D) immune globulin (human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA. As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders. A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive DU test result. If there is any doubt about the mother s Rh type, she should be given Rh O (D) immune globulin (human). A screening test to detect fetal red blood cells may be helpful in such cases. If more than 15 ml of D-positive red blood cells are present in the mother s circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose. Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after Rh O (D) immune globulin (human) administration. HyperRHO S/D Full Dose should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted. Reactions to Rh O (D) immune globulin (human) are infrequent in Rh O (D)-negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immunoglobulin is extremely rare, it has occurred. Elevated bilirubin levels have been reported in some individuals receiving multiple doses of Rh O (D) immune globulin (human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction. Please see full prescribing information contained within back pocket or visit You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Bowman JM. Maternal Alloimmunization and Fetal Hemolytic Disease. In: Reece EA et al (eds). Medicine of the Fetus and Mother. Philadelphia, PA: JB Lippincott; All rights reserved. Printed in USA. US/HR/0915/0009b