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Actemra Approved for Cytokine Release Syndrome
Genentech news release; 2017 Aug 30
The FDA has approved Actemra (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS).
Indications: Actemra is an interleukin-6 (IL-6) receptor antagonist indicated for treatment adult and pediatric patients 2 years of age and older with CAR T cell-induced severe or life-threatening cytokine release syndrome.
Dosage and administration:
- 12 mg/kg for patients <30 kg weight.
- 8 mg/kg for patients ≥30 kg weight.
- Do not exceed 800 mg per infusion.
Efficacy and safety: Approval is based on a retrospective analysis involving patients with blood cancers showing that 7 in every 10 treated with Actemra achieved resolution of CRS within 14 days.
Side effects/risks: The most common adverse reactions are upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.
FDA approves Genentech’s Actemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome [news release]. South San Francisco, CA: Genentech, Inc. August 30, 2017. https://www.gene.com/media/press-releases/14679/2017-08-30/fda-approves-genentechs-actemra-tocilizu. Accessed September 4, 2017.
Actemra [package insert]. South San Francisco, CA: Genentech, Inc. 2017. https://www.gene.com/download/pdf/actemra_prescribing.pdf. Accessed September 4, 2017.
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