Immunologic Products asdhealthcare.com

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1 Immunologic Products Bivigam Carimune NF Flebogamma DIF Gammagard S/D Low IGA Gammagard Liquid Gammaked Gammaplex Gamunex -C Hizentra HyQvia Octagam Privigen

2 Immunologic Products asdhealthcare.com Product Bivigam Carimune NF Flebogamma DIF Manufacturer Biotest Pharmaceuticals (800) biotestpharma.com bivigam.com CSL Behring (877) 355-IGIQ cslbehring.com Grifols (800) grifols.com Indications PI PID, ITP PIDD Contraindications IgA deficiency with antibodies against IgA and a history of hypersensitivity; anaphylaxis to IG IgA deficiency; IgA antibodies; anaphylaxis to IG Form Liquid Lyophilized Liquid Concentration 10% 3 / 6 / 9 / 12% 5% Sizes 5 / 10 gm 6 / 12 gm 2.5 / 5 / 10 / 20 gm Labelling for Removal of Pathogenic Prions Viral Removal Method 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. N / A N / A Yes; 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 Precipitation and removal of fraction III; solvent/ detergent treatment; 35 nm virus filtration; low ph ph 4 / Pepsin; fractionation nanofiltration; TSE removal IgA Content 200 µg / ml Trace <2400 µg / ml ( µg / ml) Average: < 3.2 mcg / ml Stabilizer Glycine; polysorbate Sucrose D-sorbitol (polyol) Sugar Content No sugar 1.67 g Sucrose 5% D-sorbitol (polyol) Sodium Content mmol / L Less than 20 mg NaCL / g protein Trace (< 3.2 mmol / L) ph ± 0.2 Average: 5.6 ± 0.1 Osmolality (mosm/kg) Pasteurization (60 C, 10 h), solvent detergent, dual sequential nanofiltration (35 nm and 20 nm), Fraction I precipitation, Fraction II + III incubation, 4% PEG precipitation and acid ph 4 treatment Half-Life 30 days 23 days 3-week dosing interval: 30 ± 9 days; 4-week dosing interval: 32 ± 5 days Storage 2 8 C; do not freeze 30 C; do not freeze 2 25 C; do not freeze Shelf-Life Can be stored until expiration date at 2 8 C 36 months 24 months RT Reconstitution Fluid/Diluent Administration N / A NaCI, D5W or SW; do not shake N/A Initial infusion rate: ml / kg / min; maintenance infusion rate: 0.06 ml / kg / min (if tolerated) 3 mg / kg / min ml / kg / min Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product s manufacturer.

3 Flebogamma DIF Grifols (800) grifols.com Gammagard Liquid gammagardliquid.com Gammagard Liquid gammagardliquid.com PIDD Replacement therapy for PI in adults and children two years of age or older; maintenance therapy to improve muscle strength and disability in adult patients with MMN Replacement therapy for PI in adults and children two years of age or older; maintenance therapy to improve muscle strength and disability in adult patients with MMN 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. IgA deficiency with antibodies against IgA and a history of hypersensitivity; anaphylactic or severe hypersensitivity to IG (Human) IgA deficiency with antibodies against IgA and a history of hypersensitivity; anaphylactic or severe hypersensitivity to IG (Human) Liquid Liquid Liquid 10% 10% 10% 5 / 10 / 20 gm 1 / 2.5 / 5 / 10 / 20 / 30 gm 1 / 2.5 / 5 / 10 / 20 / 30 gm Yes; 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 Pasteurization (60 C, 10 h), solvent detergent, dual sequential nanofiltration (35 nm and 20 nm), Fraction I precipitation, Fraction II + III incubation, 4% PEG precipitation and acid ph 4 treatment N / A Solvent/detergent viral inactivation step; low ph viral inactivation step; nanofiltration Average: < 3.2 mcg / ml Average: 37 µg / ml Average: 37 µg / ml D-sorbitol (polyol) Glycine Glycine 5% D-sorbitol (polyol) No added sugars No added sugars Trace (< 3.2 mmol / L) No added sodium No added sodium Average: 5.5 ± week dosing interval: 34 ± 10 days; 4-week dosing interval: 37 ± 13 days 2 25 C; do not freeze N / A days days 2 8 C (36 46 F) refrigerate for 36 months; RT 25 C (77 F) for 12 months within first 24 months of date of manufacture; do not freeze Solvent / detergent viral inactivation step; low ph viral inactivation step; nanofiltration 2 8 C (36 46 F) refrigerate for 36 months; RT 25 C (77 F) for 12 months within first 24 months of date of manufacture; do not freeze 24 months RT 24 months RT; 36 months refrigerate 24 months RT; 36 months refrigerate N / A D5W only D5W only ml / kg / min 0.5 ml / kg / hr (0.8 mg / kg / min) for 30 mins initial, increase every 30 mins up to 5 ml / kg / hr maintenance For 40 kg BW: 30 ml / site at a rate of 20 ml / hr / site initial; 30 ml / site at a rate of 20 to 30 ml / hr / site maintenance; For <40kg BW: 20 ml / site at a rate of 15 ml / hr / site initial; 20 ml / site at a rate of 15 to 20 ml / hr / site maintenance While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information ASD Healthcare. Chart updated November 2015.

4 Immunologic Products asdhealthcare.com Product Gammagard S/D Low IGA Gammaked Gammaked Manufacturer gammagard.com Kedrion BioPharma, Inc. (855) kedrion.com gammaked.com Kedrion BioPharma, Inc. (855) kedrion.com gammaked.com Indications PI in adults and children two years of age or older; prevention of bacterial infections in hypogammaglobulinemia and / or recurrent bacterial infections associated with B-cell CLL; prevention / control of bleeding in adult ITP; prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatrics ITP; PIDD; CIDP PI Contraindications IgA deficiency with antibodies against IgA and a history of hypersensitivity; anaphylactic or severe hypersensitivity to IG (Human) IgA deficiency with antibodies against IgA; anaphylaxis to IG IgA deficiency with antibodies against IgA; anaphylaxis to IG Form Lyophilized Liquid Liquid Concentration 5% 10% 10% Sizes 5 / 10 gm 1 / 2.5 / 5 / 10 / 20 gm 1 / 2.5 / 5 / 10 / 20 gm Labelling for Removal of Pathogenic Prions Viral Removal Method N / A N / A N / A Solvent / detergent Caprylate precipitation; filtration chromatography; low ph IgA Content <1 µg / ml in a 5% solution 46 µg / ml 46 µg / ml Stabilizer Glycine Glycine Glycine Sugar Content 20 mg / ml Glucose in a 5% solution No sugar No sugar Sodium Content Sodium chloride approximately 8.5 mg / ml in a 5% solution Trace Trace ph 6.8 ± Osmolality (mosm/kg) Half-Life 37.7 ± 15 days 35 days 35 days Caprylate precipitation; filtration chromatography; low ph Storage 25 C; do not freeze 2 8 C; do not freeze 2 8 C; do not freeze Shelf-Life 24 months RT 6 months RT; 36 months refrigerate 6 months RT; 36 months refrigerate Reconstitution Fluid/Diluent Administration SW; do not shake D5W only D5W only 5% infusion rate is 0.5 ml / kg / hr, initial; maximum rate is 4 ml / kg / hr as tolerated; 10% infusion rate is 0.5 ml / kg / hr, initial, maximum rate is 8 ml / kg / hr if no adverse effects occur; recommended maximum rates in patients at risk for renal dysfunction or thrombotic complications should be: <4 ml / kg / hr in a 5% solution; <2 ml / kg / hr in a 10% solution ml / kg / min ml / kg / min Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product s manufacturer.

5 Gammaplex Bio Products Laboratory (866) bpl.co.uk gammaplex.com Gamunex -C Grifols (800) grifols.com Gamunex -C Grifols (800) grifols.com PI, ITP ITP; PIDD; CIDP PIDD IgA deficiency with antibodies against IgA; hereditary intolerance to fructose Individuals with known anaphylactic or severe systemic response to IG. Individuals with known antibodies against IgA should receive Gamunex-C with utmost cautionary measures due to risk of severe immediate hypersensitivity reactions including anaphylaxis. Liquid Liquid Liquid Individuals with known anaphylactic or severe systemic response to IG. Individuals with known antibodies against IgA should receive Gamunex-C with utmost cautionary measures due to risk of severe immediate hypersensitivity reactions including anaphylaxis. 5% 10% Immune Globulin Injection 10% Immune Globulin Injection 5 / 10 / 20 gm 1 / 2.5 / 5 / 10 / 20 / 40 gm 1 / 2.5 / 5 / 10 / 20 / 40 gm N / A Cold ethanol fractionation; ion exchange chromotography; solvent / detergent, nanofilitration (20 nm); ultrafiltration; terminal low ph Yes; 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 Caprylate precipitation/depth filtration; caprylate incubation; depth filtration; column chromatography; low ph incubation <10 µg / ml Average: 46 mcg / ml Average: 46 mcg / ml Sorbitol; glycine; polysorbate-80 Glycine Glycine No sugar No sugar No sugar mmol / L Trace Trace mosm / kg; not less than 240 mosm / kg ± 26 days Approximately 35 days Approximately 35 days 2 25 C; do not freeze 2 8 C; do not freeze 2 8 C; do not freeze Yes; 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 Caprylate precipitation/depth filtration; caprylate incubation; depth filtration; column chromatography; low ph incubation 24 months 6 months RT; 36 months refrigerate 6 months RT; 36 months refrigerate N/A D5W only D5W only 0.6 ml / kg / hr for min; increase gradually as tolerated every 15 min to 4.8 ml / kg / hr ml / kg / min ml / kg / min While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information ASD Healthcare. Chart updated November 2015.

6 Immunologic Products asdhealthcare.com Product Manufacturer Hizentra CSL Behring (877) 355-IGIQ cslbehring.com hizentra.com HyQvia hyqvia.com HyQvia Recombinant Human Hyaluronidase hyqvia.com Indications PI PI in adults PI in adults Contraindications IgA deficiency; anaphylaxis to polysorbate and IG; hyperprolinemia IgA deficiency with antibodies against IgA; anaphylaxis to IG; hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HyQvia Form Liquid Liquid Liquid Concentration 20% 10% 10% Sizes 1 / 2 / 4 / 10 gm 2.5 / 5 / 10 / 20 / 30 gm 1.25 / 2.5 / 5 / 10 / 15 gm Labelling for Removal of Pathogenic Prions Viral Removal Method N / A N / A N / A ph 4; virus and depth filtration; TSE removal Solvent/detergent viral inactivation step; low ph viral inactivation step; nanofiltration IgA Content 50 mcg / ml Average: 37 μg / ml 0 μg / ml IgA deficiency with antibodies against IgA; anaphylaxis to IG; hypersensitivity to Hyaluronidase or Recombinant Human Hyaluronidase of HyQvia 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 Stabilizer L-proline Glycine Human albumin (1.0 mg / ml) Sugar Content No sugar No added sugar No added sugar Sodium Content Trace amounts <10 mmol / L No added sodium 8.5 mg / ml ph Osmolality (mosm/kg) Half-Life N / A N / A N / A Storage 2 25 C; do not freeze; do not shake 2 8 C for up to 36 months 2 8 C for up to 36 months Shelf-Life 30 months 3 months RT; 36 months refrigerated at 2 8 C; do not freeze Reconstitution Fluid/Diluent Administration N / A N / A N / A using infusion pump; 15 ml / hour for first infusion up to 25 ml / hour on subsequent infusions as tolerated Infusion requires an infusion pump capable of infusing a patient s therapeutic dose at infusion rates up to 300 ml / hr / site; the pump must have the ability to titrate the flow rate up or down if required to improve tolerability; to ensure maximum flow rates, use a subcutaneous needle set that is 24 gauge and labeled for high flow rates 3 months RT; 36 months refrigerated at 2 8 C; do not freeze Infusion requires an infusion pump capable of infusing a patient s therapeutic dose at infusion rates up to 300 ml / hr / site; the pump must have the ability to titrate the flow rate up or down if required to improve tolerability; to ensure maximum flow rates, use a subcutaneous needle set that is 24 gauge and labeled for high flow rates Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product s manufacturer.

7 Octagam Octapharma (866) octapharma.com octagamus.net Octagam Octapharma (866) octapharma.com octagamus.net Privigen CSL Behring (877) 355-IGIQ cslbehring.com privigen.com PI ITP PI; ITP 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 History of anaphylactic or severe systemic reactions to human immunoglobulin; IgA deficient patients with antibodies against IgA and a history of hypersensitivity Liquid Liquid Liquid 5% (50 mg / ml) 10% (100 mg / ml) 10% 1 / 2.5 / 5 / 10 gm 2 / 5 / 10 / 20 gm 5 / 10 / 20 / 40 gm N / A N / A N / A IgA deficiency; anaphylaxis to polysorbate and IG; hyperprolinemia Cold ethanol fractionation, solvent / detergent treatment; ph4 treatment Cold ethanol fractionation; solvent / detergent treatment; ph4 treatment ph 4; virus and depth filtration; TSE removal 200 µg / ml Average 106 μg / ml 50 mcg / ml Maltose Maltose L-proline 10% (100 mg / ml) Maltose 9% (90 mg / ml) Maltose No sugar 30 mmol / L 30 mmol / L Trace amounts <10 mmol / L days Not tested in PI, cannot be done in ITP N / A 24 months at +2 C to +25 C (36 F to 77 F) from the date of manufacture; do not freeze 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 6 months at +25 C (77 F); after storage at +25 C (77 F) the product must be used or discarded; do not freeze 24 months 24 months 30 months N/A N / A N / A 2 25 C; do not freeze; do not shake ml / kg / min; flush with NS or D5W ml / kg / min; flush with NS or D5W ml / hr / site; max 50 ml / hr for all sites combined While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information ASD Healthcare. Chart updated November 2015.

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