Actemra Indicated for CAR-T Side Effects
August 30, 2017 – The U.S. FDA has approved Actemra® (tocilizumab), manufactured by Genentech, to treat severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. Also known as a cytokine storm, CRS is typically a mild condition that causes flu-like symptoms, such as headaches, nausea, fever, and rashes. However, severe CRS can cause acute respiratory syndrome, heart failure, multi-organ collapse, or death. Approximately half of patients treated with the CAR-T product Kymriah™ in a clinical trial developed severe CRS.
Actemra, a monoclonal antibody, works by interfering with interleukin-6 (IL-6) to reduce inflammation. Recommended dosing is 8mg/kg or 12mg/kg, delivered intravenously up to four times, each dose separated by eight hours or more. To control CRS, Actemra may need to be given concurrently with high dose steroids. The drug also carries a black box warning that it may increase the risk of serious infections, such as tuberculosis.
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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.