The PROOF is in the proven effectiveness

The reason people take IGIV therapy is to feel better—and to live a healthier life. GAMUNEX has been proven effective for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), primary immunodeficiency (PI) disease, and idiopathic thrombocytopenic purpura (ITP).1-3

In clinical studies, the most common adverse reactions with GAMUNEX were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).4

The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).4

Significant improvement in CIDP patient outcomes

In a landmark GAMUNEX trial, the largest-ever CIDP study,4 disability scores maintained significant improvement through week 24 (primary endpoint) and grip strength improved in both hands.3

Also, more than 87% of patients given GAMUNEX every 3 weeks did not relapse during the extension phase.3

Fewer sinus infections

According to the Immune Deficiency Foundation, most people with primary immunodeficiency suffer from sinus infections. That's why reduced sinus infections is a great indicator that your IGIV therapy is working effectively.5

In a large study, GAMUNEX prevented validated and clinically defined acute sinus infections for the patients who received it.1

Double the platelet count

For people with ITP, it is important that their therapy increase their platelet count and keep it at a healthy level. Platelets are the cells found in the blood that control bleeding.6,7

In a study, GAMUNEX doubled patients' platelet count and maintained this increase for more than 4 weeks, without the need for additional IGIV treatment.2

Made in the United States with the unique caprylate purification process*

The antibody that comes from human plasma is fragile and can be damaged if not treated gently.4,8

Talecris has a unique technology that purifies the plasma to protect antibodies. During the manufacturing of GAMUNEX, the plasma also goes through numerous steps to remove and inactivate viruses.4,8

Gamunex is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Ask your doctor if GAMUNEX is right for you.


*GAMUNEX caprylate/chromatography process vs Gamimune® N, 10% [Immune Globulin Intravenous (Human)] solvent/detergent.

Important Safety Information for GAMUNEX

Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.

Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying GAMUNEX full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:

  1. Roifman CM, Schroeder H, Berger M, et al, and the IGIV-C in PID Study Group. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: a randomized double-blind trial. Int Immunopharmacol. 2003;3:1325-1333.

  2. Bussel JB, Eldor A, Kelton JG, et al, and the IGIV-C in ITP Study Group. IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life. Thromb Haemost. 2004;91:771-778.

  3. Hughes RAC, Donofrio P, Bril V, et al, on behalf of the ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7:136-144.

  4. GAMUNEX [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics; 2008.

  5. Immune Deficiency Foundation. Primary immune deficiency diseases in America: the first national survey of patients and specialists. http://www.primaryimmune.org/publications/surveys/First_National_Survey_of_Patients_and_Specialists_(1995).pdf. Accessed May 27, 2009.

  6. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008.

  7. Dorland's Illustrated Medical Dictionary. 27th ed. Philadelphia, PA: W.B. Saunders; 1988.

  8. Lebing W, Remington KM, Schreiner C, Paul HI. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography. Vox Sang. 2003;84:193-201.