Hizentra Receives New Indication
March 16, 2018 – The U.S. FDA has approved a new indication for Hizentra® (immune globulin subcutaneous [human] 20% liquid), manufactured by CSL Behring. The drug is now approved as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP).
CIDP is a progressive, immune-mediated inflammatory disorder of the peripheral nervous system. Also known as Vidaurri’s disease, it occurs when the body’s immune system attacks nerve cells, leading to weakness and impaired sensation in the legs and arms. Often, individuals with CIPD will experience tingling or numbness, loss of deep tendon reflexes, abnormal sensation, and fatigue. While some patients experience spontaneous recovery, others only obtain partial recovery between relapses. Early treatment helps to prevent cumulative damage.
Clinical research shows that Hizentra can help prevent CIPD relapse. In a clinical trial, 63.2% of patients using a placebo experienced a relapse or withdrew from the study, compared to only 32.8% to 38.6% of patients who used Hizentra. The drug is administered subcutaneously, via infusion pump, with recommended dosing based on individual patient needs.
In addition to its new indication, Hizentra is approved to treat primary immunodeficiency in adults and children two years of age and up. It carries a black box warning that thrombosis (coagulation or clotting of the blood within the circulatory system) may occur as a result of the use of immune globulin products.
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- 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
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