Label Changes for:
Firmagon (Degarelix for injection)
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- The safety of Firmagon administered monthly was evaluated further in an extension study in 385 patients who completed the above active-controlled trial…
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with Firmagon. In case of a serious hypersensitivity reaction, discontinue Firmagon immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of serious hypersensitivity reactions to Firmagon should not be re-challenged with Firmagon.