Drug Approved for Rare Neurologic Disease
Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN
Monday October 27, 2008
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The U.S. Food and Drug Administration recently approved Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) to treat chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder that attacks the myelin sheaths of the peripheral nervous system. The disorder causes progressive weakness and impaired sensory function in the legs and arms. Patients with the disorder also experience numbness, tingling, and loss of deep tendon reflexes.
The drug has received “orphan drug” status, a designation providing manufacturers with financial incentives to develop treatments for rare diseases affecting fewer than 200,000 people in the United States. Without that designation, many drugs would not be investigated, manufactured, and made available. Clinical trials have demonstrated that Gamunex helps improve motor functions including walking and the ability to perform activities with the hands.
The exact mechanism of action is unknown; however, researchers attribute the motor system improvements to the ability seen with other immune globulin products to alter the body’s inflammatory response. Gamunex is administered by intravenous infusion every three to four weeks, based on individual patient response.
Adverse reactions: Monitor for headache, fever, increased blood pressure, rash, joint pain, chills, back pain, nausea, and lightheadedness. Other, more serious reactions seen with immune globulin intravenous (Human) products include renal dysfunction, acute renal failure, osmotic nephrosis, noncardiogenic pulmonary edema, hemolytic anemia, and death.
Patient teaching: Reinforce to patients that they should immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. Patients must also be informed that there are certain risks associated with Gamunex use because immune globulin (antibody) products are obtained from pooled human blood plasma. There is a small risk of virus transmission, including the virus responsible for Creutzfeldt-Jakob disease.
Caution: Review current drug information before administering and monitoring medications.
Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.
References
FDA approves treatment for rare neurologic disease. FDA Web site. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01884.html. Accessed October 15, 2008.
Gamunex product information. Talecris Biotherapeutics Web site. http://www.talecris-pi.info/inserts/Gamunex.pdf. Accessed October 15, 2008.
