Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged ≥2 years. Actemra can be given alone or in combination with methotrexate (MTX) in patients with SJIA. In 2011, FDA approved the intravenous (IV) formulation of Actemra for patients aged ≥2 years with active SJIA. Genentech is headquartered in San Francisco, CA.
Dosage/administration: The recommended intravenous SJIA dosage is every 2 weeks. For patients <30 kg weight, the dosage is 12 mg per kg. For patients ≥30 kg weight, the dosage is 8 mg per kg.
Adverse effects: The most common adverse reactions (incidence of at least 5%) were upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and
injection site reactions.
FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis (SJIA), a rare form of juvenile arthritis. [news release]. San Francisco, CA: Genentech. September 13, 2018. https://www.pharmalive.com/fda-approves-subcutaneous-formulation-of-actemra-for-use-in-active-systemic-juvenile-idiopathic-arthritis-sjia-a-rare-form-of-juvenile-arthritis/. Accessed September 13, 2018.
Must Reads in FDA Actions
FDA Approves Gloperba Oral Solution for Gout Flares, FirstWord Pharma news release; 2019 Feb 26
FDA Approves Hyrimoz for Chronic Conditions, Sandoz news release; 2018 Oct 31
FDA Approves Subcutaneous Actemra for Active SJIA, PharmaLive news release; 2018 Sep 13
FDA Approves Olumiant for Rheumatoid Arthritis, Eli Lilly, Incyte news release; 2018 Jun 1
FDA Approves Consensi for Osteoarthritis Pain, FirstWord Pharma news release; 2018 May 31