Posted from: Monday, October 08, 2018 - 12:38 PM - Present

Actemra Receives Expanded Pediatric Indication

September 13, 2018 – The U.S. FDA has approved an expanded indication for Actemra® (tocilizumab) for subcutaneous injection, manufactured by Genentech. The product is now approved to treat active systemic juvenile idiopathic arthritis (SJIA) in patients who are at least two years of age.

The rarest form of juvenile idiopathic arthritis, SJIA affects an estimated 30,000 children in the United States. Signs and symptoms include joint inflammation, fevers that last two weeks or more, rashes, and enlarged internal organs. Often, patients experience flares and may have symptom-free periods between. This can lead to delayed diagnosis.

Actemra blocks the activity of interleukin-6 receptors, helping to halt inflammatory processes in the body. Recommended dosing for the new SJIA indication depends on the patient’s weight. Actemra SC comes in prefilled syringes that caregivers or patients can administer at home. Previously, pediatric SJIA patients could only receive treatment with Actemra using the intravenous (IV) form, which must be administered in a doctor’s office or other healthcare facility.

A black box warning cautions that Actemra can raise a patient’s risk of serious infection, including fungal, bacterial, and viral infections. Patients should be tested for tuberculosis before and during treatment with Actemra. If a serious infection occurs, treatment with Actemra should be discontinued until the infection is controlled.

Actemra first received FDA approval in 2010, and is indicated to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and cytokine release syndrome in addition to SJIA.

 

Last Updated Saturday, December 15, 2018 - 12:58 AM.