Gamunex?? is a ready-to-use 10% sterile solution of human immune globulin protein for intravenous administration.1 The Gamunex?? advanced product features and composition are rooted in a new revolutionary caprylate/chromatography-based purification process.

Gamunex provides excellent tolerability.1 The PI trial for Gamunex reported a low incidence of adverse events.3 The trial results further showed Gamunex is well tolerated even at the higher doses required for ITP therapy.1 The most common side effects noted during the clinical trials included headache, vomiting, fever, nausea, rash, and back pain. More than 90% of those adverse events were mild to moderate and transient.

Gamunex?? is indicated as replacement therapy for PI states in which severe impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.1 Gamunex?? is indicated in ITP to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.1

We conducted the first licensure-relevant randomized, double-blind, controlled, statistically powered, head-to-head therapeutic equivalence IGIV trials for PI and ITP. The trial program included 7 trials and more than 350 patients2: The size and design of the studies have provided unprecedented proof of efficacy, safety, and tolerability. Gamimune?? N, 10% was the comparator in many of these trials.2

Gamunex?? is well tolerated.1 The adverse event (A/E) profile in the PI study indicated a very low incidence: Based on the number of total infusions, the most common A/Es were increased cough (1.7%), pharyngitis (0.8%), headache (0.8%), fever (0.1%), nausea (0.5%), and urticaria (0.5%). Gamunex?? is well tolerated even at higher doses in ITP.

Antibodies in Gamunex?? may interfere with the response to live viral vaccines such as measles, mumps, and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after Gamunex?? administration.1

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 Creutzfeldt- Jakob disease (CJD) and vCJD agents. Several of the individual production steps in the Gamunex manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps included cloth filtration and depth filtration.

Consistent and reliable supply of this lifesaving therapy is of utmost importance. Talecris has addressed this issue with a variety of measures and investments: Talecris built a totally new, dedicated production facility for the manufacture of Gamunex??, a facility that meets or exceeds current Good Manufacturing Practices (cGMP) standards.

No. Caution should be exercised in patients hypersensitive or allergic to latex. As a precaution, latex-sensitive healthcare providers should use proper gloves when handling the product stopper.2

Gamunex?? offers a long shelf life. Product may be stored for 36 months at 2??C to 8??C (36??F??"46??F), and product may be stored at temperatures not to exceed 25??C (77??F) for up to 6 months anytime during the 36-month shelf life, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.1

It is recommended that Gamunex?? should initially be infused at a rate of 0.01 mL/kg/min (1 mg/kg/min) for the first 30 minutes. If welltolerated, the rate may be gradually increased to a maximum of 0.08 mL/kg/min (8 mg/kg/min). If side effects occur, the rate may be reduced, or the infusion interrupted until symptoms subside. The infusion may then be resumed at a rate that is comfortable for the patient.1

Talecris is working with third-party payers such as Medicare, Medicaid, Federal Supply Schedule (FSS), insurance carriers, and others, to minimize possible reimbursement issues. Please consult with your specific group to determine the current status of reimbursement for Gamunex??.

Before FDA approval of Gamunex, we conducted the largest clinical trials program ever performed for the licensure of an IGIV product. The results demonstrated the significant benefits of Gamunex, including its excellent efficacy, safety, and tolerability profile.

In the United States, Gamunex is indicated as replacement therapy for PI disorders in which impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, a common variable immunodeficiency; X-linked immunodeficiency with hyper IgM; Wiskott-Aldrich syndrome; and severe combined immunodeficiencies.1 Gamunex also is indicated in ITP to rapidly raise platelet counts to prevent bleeding or allow a patient with ITP to undergo surgery.1

Gamunex is not compatible with saline. If dilution is required, Gamunex may be diluted with 5% dextrose in water (D5/W).1

Its size: Most previous licensure-relevant trials were in a magnitude of 20 to 40 patients-the pivotal Gamunex?? trial included 172 patients. Its design: It was the first licensure-relevant trial in PI that was randomized, double-blind, controlled, statistically powered, and included head-to-head comparisons of 2 different IGIV products. Its endpoints: Previous licensure-relevant trials often focused on surrogate endpoints (eg, IgG level elevations).

Companies report A/Es differently, often based on trial standards originating from the 1980s/1990s and not providing the necessary details. The Gamunex?? clinical trial program was the most detailed and precise clinical program ever initiated for an IGIV???Talecris gathered and analyzed more information than others had previously. Previous reports indicate an increasing incidence (up to 5%) of serious A/Es associated with IGIV therapy.

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 utmost cautionary measures, due to the risk of severe immediate hypersensitivity reactions, including anaphylaxis.

We have introduced a new paradigm in safety evaluation to assess the virus reduction capacity of its Gamunex?? process. It has 2 cornerstones2: Robustness testing of all relevant safety steps (effectiveness validated outside normal production range)

Gamunex?? may be diluted with 5% dextrose in water (D5W). No other drug interactions or compatibilities have been evaluated.1

We started with a clean sheet to design a completely new manufacturing process, because the old processes did not provide the flexibility we needed to make the significant improvements we had in mind for Gamunex. In the past, IGIV product development was simply based on retrofitting a decades-old process. Our team identified Caprylate/Chromatography as a gentle, yet very effective and safe, process to purify Gamunex, resulting in enhanced quality and reliability of the product supply.

Patients with bronchiectasis who received Gamunex?? showed a trend toward fewer infections compared with those who received Gamimune?? N, 10% (7% vs 25%).

has demonstrated excellent clinical efficacy1 ???setting a benchmark other IGIVs have to compare with. A consistent trend in favor of Gamunex?? challenges the perception that IGIVs produced by different processes are therapeutically equivalent.1

When choosing the 'best IGIV,' one needs to consider the perspective of what is best for the individual patient."8 Clinical considerations for fluid-restricted patients (patients with cardiac impairment, or young children): Gamunex?? is a 10% concentration, which translates into half the fluid volume of standard 5% IGIV products, and contains only a trace amount of sodium.

Yes. An important precondition to gain FDA approval is to demonstrate conclusive evidence for a plasma-derived product's virus safety. Gamunex?? has a multitude of preproduction and production safety steps.2