New Drug Warnings - August 2021


raxibacumab

Generic only

NEW WARNING

The FDA has required prescribing information for raxibacumab to carry a boxed warning to alert health care providers and patients of the risk of hypersensitivity reactions and anaphylaxis. Hypersensitivity reactions, including anaphylaxis, have been reported during or after intravenous administration.

Administration of raxibacumab must be in a monitored setting where appropriate equipment, medication (including epinephrine), and personnel trained to manage hypersensitivity, anaphylaxis, and shock are available. Patients must be closely monitored for hypersensitivity reactions (rash, urticaria, pruritus, chills, chest and throat tightness, lip and throat swelling, hypotension) during and after administration. If signs or symptoms occur, the infusion must be stopped and the patient treated appropriately.

Patients should be told of the risk for hypersensitivity reactions and instructed to report signs and symptoms immediately.

Adverse effects from the use of raxibacumab should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: August 2021

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