Gamunex® is indicated as replacement therapy for primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP).
Gamunex® is contraindicated in individuals with known anaphylactic or severe systemic response to immune globulin (human). Individuals with severe, selective IgA deficiencies (serum IgA <0.05 g/L) who have known antibody against IgA (anti-IgA antibody) should only receive Gamunex® with cautionary measures.
 Proof of Principle
The Process is the Product.
IGIVs vary significantly as a result of different production processes. Although high biological activity is the primary objective in IGIV manufacturing, these processes result in varying product features that may affect biological activity and ultimately the efficacy of the IGIV.
The Gamunex® Process
(Caprylate/Chromatography)
The Gamunex® Process was designed from scratch to better meet the critical needs of both patients and caregivers.
Impact of production on clinical outcome
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Surprising clinical outcomes
For the first time, unprecedented head-to-head clinical trials demonstrate that not all IGIVs produce the same clinical outcomes:
Although designed as therapeutic equivalence trials demonstrating that Gamunex® is at least as effective as Gamimune® N, 10%, Immune Globulin Intravenous (Human), Gamunex® showed surprising results such as:
- a significant reduction of annual validated infection rates in PI; and
- an excellent platelet response in both acute and chronic ITP.
Gamunex® is making the difference in IGIV.
Gamunex® is produced using a completely new manufacturing process to allow greater flexibility in order to meet the critical needs of both patients and caregivers.
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