Immune Globulin Comparison Table

Transcription

1 I. Formulation data Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Formulation Lyophilized Liquid Liquid Liquid Liquid Concentration 5% or 10% upon reconstitution Administration set provided? IgA content 2.2 µg/ml (In a 5% solution) Osmolality (in mosmol/kg) Physiological osmolality is approx % % 10% 16% Yes No No No No Not indicated in 46 µg/ml (average) 140 µg/ml 2.7 µg/ml (average) Not indicated in Not indicated in ph Relevant non medical ingredients In a 5% solution: 3 mg/ml Albumin (human) 22.5 mg/ml Glycine 20 mg/ml Glucose 2 mg/ml PEG 1 µg/ml Tri(n-butyl) phosphate 1 µg/ml Octoxynol9 100 µg/ml Polysorbate M Glycine (No preservative) M Glycine as a stabilizing agent (No preservative) 250 mm L-Proline (no preservative) 22.5 mg/ml Glycine 0.3% Sodium chloride (No preservative) Page 1 of 7

2 I. Formulation data Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Shelf life Not indicated in Sodium content Approximately 8.5 mg/ml (In a 5% solution) Storage Up to 25 C requirements Sugar content 20 mg/ml (2%) Glucose (in 5% solution) No sucrose 36 months 36 months Not indicated in 24 months None listed None listed 1 meq/l or less 0.3 % 2-8 C (36 months) 2-8 C (36 months) Up to 25 C (6 months) Up to 25 C (for a single period of up to 9 months within the first 24 months from date of manufacture) Can be stored at room temperature (up to 25 C) Keep in its original carton to protect it from light None listed None listed Contains no carbohydrates stabilizers (e.g.: sucrose, maltose) 2-8 C Keep vials in storage box until use None listed Page 2 of 7

3 Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Administration Intravenous Intravenous Intravenous Intravenous Subcutaneous injection Concentration Infusion rate & Dosage 5% or 10% upon reconstitution For a 5% solution: 4 ml/kg/hr maximum (3.3 mg/kg/min. For a 10% solution: 8 ml/kg/hr maximum (Calculated rate: 13.3 mg/kg/min. Up to 1000 mg/kg/day for ITP Do Not Inject Intravenously 9-11% % 10% 16% 0.14 ml/kg/min. (14 mg/kg/min. Up to 1000 mg/kg/day for ITP 8 ml/kg/hr maximum (Calculated rate: 13.3 mg/kg/min. Up to 1000 mg/kg/day for ITP Recommended initial infusion rate is 0.5 mg/kg/min. If well tolerated, the rate of administration may gradually be increased up to a maximum infusion rate of 12 mg/kg/min. Usual Dose for: PID and SID is mg/kg body weight (bw) every 3-4 weeks Usual Dose for: ITP is 1 g/kg bw for 2 consecutive days, resulting in a total dosage of 2 g/kg bw 15 ml per injection site at a rate of 20 ml/hr per site 100 to 200 mg/kg body weight (weekly) Page 3 of 7

4 Diluent, if further dilution is required Half-life (in vivo) Drug interaction Water for Injection 5% dextrose in water (for reconstitution and (D5W) - Not saline. dilution) Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin 5% dextrose in water (D5W) - Not saline ± 15 days days Approximately days. May interfere with patient responses to live vaccines. May interfere with the response to live viral vaccines. May interfere with patient responses to live vaccines. 5% dextrose in water (D5W) Median of 36.6 days in PID study May transiently impair the efficacy of live attenuated virus vaccines. None listed Not indicated in May transiently impair the efficacy of live attenuated virus vaccines. Indications 1. Primary immunodeficiency diseases 2. B-cell chronic lymphocytic leukemia (CLL) 3. Idiopathic 1. Primary and secondary immune deficiency syndromes (PID, SID) 2. Idiopathic 3. Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, 18 years of age or older 1. Primary and secondary immunodeficiency syndromes (PID, SID) 2. Idiopathic 1. Primary and secondary immuno deficiency syndromes (PID, SID) 2. Immune 1. Primary immune deficiency (PID) in adult and pediatric patients Page 4 of 7

5 Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Contraindications History of severe systemic or anaphylactic reactions to IVIG. In patients with selective IgA deficiency where it is the only abnormality of concern. Known hypersensitivity to formulation ingredients or components of container. Known anaphylactic or severe systemic response to human immuno globulins. Hypersensitivity to the active substance or to the excipient. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. Previous anaphylactic or severe systemic reaction to human immune globulin. In patients with hyperprolinemia due to the presence of L- proline as stabilizer. IgA deficiency. History of anaphylactic or severe systemic response to immune globulin preparations. In patients with selective IgA deficiency who have known antibody against IgA. Individuals with severe, selective IgA deficiencies who have known antibody against IgA (anti-iga antibody) should only receive Gamunex / IGIVnex with utmost cautionary measures. Hypersensitivity to this drug or to any ingredient in the formulation or component of the container Page 5 of 7

6 Warnings, Precautions & Adverse reactions (Please refer to the Product Monographs for a detailed listing) Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Renal dysfunction Aseptic meningitis Renal dysfunction Renal dysfunction Aseptic meningitis Acute renal failure syndrome (AMS) Acute renal failure Acute renal failure syndrome Osmotic nephrosis Thrombo-embolic Osmotic nephrosis Osmotic nephrosis Thromboembolism events Death Death Death Renal impairment Renal impairment Immediate Hemolysis Hemolysis/ anaphylactic and Death Impaired renal haemolytic anemia Hemolysis/ hypersensitivity Hemolysis/ haemolytic anemia functions Transfusion reactions haemolytic anemia Transfusion related related acute lung Transfusion Thrombotic events Transfusion acute lung injury injury (TRALI) related acute lung Aseptic meningitis related acute lung injury (TRALI) (TRALI) Thrombotic events syndrome (AMS) injury (TRALI) Allergic reactions: Thrombotic events Aseptic meningitis Impaired efficacy fall in blood Aseptic meningitis syndrome (AMS) of live attenuated pressure, dyspnea, syndrome (AMS) cutaneous virus vaccines reactions Risk of renal dysfunction Minor reactions such as: mild to moderate hypotension, headache, fatigue, chills, backache, fever, nausea, etc. Chills, fever headache, back pain, dizziness, immediate anaphylactic and hypersensitivity reactions, etc. Hypersensitivity, headache, nausea, fatigue, chills, pain, etc. Should be used with caution in patients over 65 years of age who are judged to be at increased risk of developing renal insufficiency. Chills, fever, headaches, malaise, vomiting arthralgia, back pain Cardiovascular reactions Local reaction at injection site: rash, redness, etc Page 6 of 7

7 III. Manufacturing & Safety data Gamunex /IGIVnex Gammagard Liquid Privigen Vivaglobin Manufacturing process Cohn-Oncley fractionation, ultrafiltration, ion exchange and solvent / detergent treatment Combination of cold ethanol fractionation, caprylate precipitation and filtration and anion-exchange Modified Cohn-Oncley cold alcohol fractionation procedure, ion exchange chromatographies, solvent detergent treatment, nanofiltration and low ph and elevated temperature incubation Combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange Cold alcohol fractionation Viral reduction steps (Please refer to the Product Monographs for further details) 1. Cold ethanol fractionation steps 2. Solvent / detergent treatment 1. Caprylate precipitation / incubation 2. Column 3. Final container low ph incubation 1. Solvent / detergent treatment 2. Nanofiltration (35 nm) 3. Incubation at low ph and elevated temperature of the final filled product. 1. Octanoic acid fractionation 2. ph 4 incubation 3. Depth filtration 4. Virus filtration (20 nm) 1. Partitioning (precipitation) 2. Pasteurization in aqueous solution at 60 C for 10 hours Reference Monographs Approval/Revision Dates: January 15, Gamunex October 17, 2008 Privigen July 10, 2009 Gammagard Liquid July 9, IGIVnex February 3, 2009 Vivaglobin December 7, Page 7 of 7