New Dosage Form of Actemra Approved

November 26, 2018 – The U.S. FDA has approved the ACTPenTM 162mg/0.9mL prefilled auto-injector, a new dosage form of Genentech's Actemra® (tocilizumab). It is indicated for the treatment of certain patients who have rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), or systemic juvenile idiopathic arthritis (SJIA).

Actemra is also available in dosage forms for intravenous infusion and for subcutaneous injection with a pre-filled syringe. In clinical studies, the ACTPen auto-injector was found to offer a safe and effective option for patients. However, the ability of pediatric patients to self-inject was not tested. Caregivers, rather than the patients themselves, should be the ones to administer Actemra through the ACTPen for approved pediatric indications.

Genentech has not yet announced pricing information, but plans to launch the ACTPen in January 2019.