Uncover the GAMUNEX-C manufacturing process
THE UNIQUE GAMUNEX-C CAPRYLATE/CHROMATOGRAPHY PURIFICATION PROCESS
- Maintains IgG in liquid phase throughout to minimize the risk of denaturing proteins1*
- Requires no sugar stabilizer
GAMUNEX-C IS THE FIRST FDA-APPROVED IVIG FOR CIDP
- GAMUNEX-C is FDA approved for the treatment of CIDP to improve neuromuscular disability and impairment, and for maintenance therapy to prevent relapse
- GAMUNEX-C is formulated with the first manufacturing process that produces immune globulin products with an FDA-approved indication for CIDP
GAMUNEX-C HAS FDA-APPROVED LABELING FOR PRION REMOVAL
- Zero confirmed cases of virus or prion disease transmission, including the human form of bovine spongiform encephalopathy (mad cow disease)
- Proven pathogen safety steps
6 steps with the capacity to remove/inactivate viruses2
- Caprylate precipitation/depth filtration, caprylate incubation, column chromatography, depth filtration, nanofiltration, and low pH incubation
- 2 depth filtrations, in sequence, provide the capacity to remove prion infectivity2
- Capacity to remove/inactivate emergent pathogens (eg, West Nile virus)3
- 6 steps with the capacity to remove/inactivate viruses2
Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
ADVERSE REACTIONS ACROSS ALL INDICATIONS
In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP).
The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).
GAMUNEX-C is a proven formulation for a wide range of patients.2,4
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