The PROOF is in our multiple indications


If you have chronic inflammatory demyelinating polyneuropathy (CIDP), primary immunodeficiency (PI), or idiopathic thrombocytopenic purpura (ITP), ask your doctor if GAMUNEX is right for you.

GAMUNEX is an IGIV therapy manufactured using plasma from healthy donors collected in centers across the United States and is indicated for1:

  • Patients with CIDP: when the body's immune system mistakes myelin—the protective covering around nerve fibers—as foreign and attacks it,2 GAMUNEX provides healthy antibodies to block the immune and inflammatory processes that attack and destroy myelin1
  • Patients with PI: when the body lacks the healthy antibodies needed to fight off infections caused by viruses and bacteria,3 GAMUNEX provides those healthy antibodies1
  • Patients with ITP: when the body makes antibodies that destroy platelets, the cells found in the blood that control bleeding,2 GAMUNEX provides healthy antibodies to bring the platelet count back to a healthier level1

If you have CIDP, PI, or ITP and are being treated with IGIV, you will receive an infusion of IGIV on a regularly scheduled basis as determined by your doctor. It will most likely be given to you through a vein in your arm at a doctor's office, hospital, or infusion center. You may also be able to arrange to have your infusion at home.

Ask your doctor if GAMUNEX is right for you.

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

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

  3. 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.