FDA Approves Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart - Drug Information Update

U.S. Food and Drug Administration sent this bulletin at 03/18/2021 05:30 PM EDT

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves First Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart

FDA has approved Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older.

Recurrent pericarditis is characterized by a remitting-relapsing inflammation (or symptoms that fluctuate in severity) of the pericardium, a thin tissue sac surrounding the heart. Pericarditis often causes chest pain, which can be sharp. This chest pain worsens when patients take a deep breath.

Serious, life-threatening infections have been reported in patients taking Arcalyst. Patients with active or chronic infections should not take the drug. Patients should also avoid live vaccines while taking Arcalyst.

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