Gammaplex 10% Approved for Immune Deficiencies
February 6, 2017 - The U.S. FDA approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid). It is indicated to treat adults who have primary immunodeficiency (PI) or chronic immune thrombocytopenic purpura (ITP). The manufacturer, Bio Products Laboratory, also markets Gammaplex® 5% (immune globulin intravenous [human], 5% liquid) in the United States. Intravenous immunoglobulins (IVIGs) are used as replacement for patients who have immunoglobulin deficiencies. They are dosed by weight. For treating PI, one Gammaplex 10% infusion is recommended every three to four weeks. Recommended dosing for the treatment of ITP is one infusion on each of two successive days when needed to increase platelet count. In clinical studies, the average infusion time for the 10% strength was about one hour – approximately one-half the average time for an infusion of Gammaplex 5%. Labeling for all IVIG products includes warnings that they may cause blood clots, kidney damage or kidney failure.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.