The PROOF is in our CIDP indication

What is CIDP?

CIDP (chronic inflammatory demyelinating polyneuropathy) is a neurological disorder characterized by progressive weakness, tingling, or numbness in the legs and arms. Symptoms are caused by damage to the myelin sheath—the protective covering around nerve fibers—in the nerves of your arms and legs (peripheral nerves).1

Although the exact cause is not known, CIDP is considered an autoimmune disorder.1 In a healthy person, the body's immune system protects against disease by making antibodies to fight off infections caused by viruses and bacteria.

In people with CIDP, the body's immune system mistakes myelin as foreign and attacks it.1

GAMUNEX is the first and only medicine FDA approved for treating CIDP. GAMUNEX is a leading immune globulin intravenous (IGIV) therapy. Immunoglobulin is another name for the purified antibodies that assist the body's immune system.2

In people with CIDP, GAMUNEX provides healthy antibodies to block the immune and inflammatory processes that attack and destroy myelin.3

  • If you have CIDP and your healthcare provider recommends IGIV therapy, you will receive an infusion on a regularly scheduled basis
  • The infusion will most likely be given to you through a vein in your arm at a doctor's office, hospital, or infusion center
  • In clinical studies, the most common adverse reactions with GAMUNEX were headache, fever, chills, hypertension, rash, nausea, and asthenia3
  • The most serious adverse reaction was pulmonary embolism (PE) in one subject with a history of PE.3
  • IGIV products have been associated with kidney disease.4 If you experience decreased urination, sudden weight gain, water retention, swelling, or shortness of breath (which could be symptoms of kidney disease), contact your doctor right away.3 IGIVs containing sugar stabilizers have caused the greatest number of kidney-related side effects.4 GAMUNEX contains no sugar and no preservatives.3 Please see the Important Safety Information below
  • In all IGIV products, including GAMUNEX, serious side effects include reports of fluid in the lungs that is not caused by heart disease (sometimes referred to as transfusion-related acute lung injury [TRALI]).3 There have also been rare cases of low red blood cell count, inflammation of the membranes that surround the brain (aseptic meningitis), blood clotting, and blood vessel blockage. High protein content in the blood, thickening of the blood (increased serum viscosity), and low levels of sodium in the blood may occur in patients receiving IGIV therapy3

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

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

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

  4. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6:592-599.