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# FDA OKs Genentech’s ACTPen Autoinjector
- URL: https://www.fdaweb.com/fda-oks-genentechs-actpen-autoinjector/
- Published: 2018-11-26T12:00:00.000Z
- Updated: 2026-09-15T00:46:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142888

FDA has approved Genentech’s ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, and for adult patients with giant cell arteritis. The ACTPen may also be administered by caregivers to patients two years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis. FDA originally approved Actemra’s intravenous infusion formulation for adults with RA in 2010 and a pre-filled syringe formulation for subcutaneous injection in 2013.  
  
ACTPen’s approval is based on clinical data from two studies that found that a single-dose administration of 162 mg Actemra with the ACTPen was bioequivalent to administration with the currently marketed pre-filled syringe. Additionally, they found that intended users of the ACTPen were successful in performing tasks required to administer doses successfully.