Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)
- edited...If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation or aggressive behavior towards others is identified, discontinue treatment with INTRON A and follow the patient closely, with psychiatric intervention as appropriate. Narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until the adverse effects have resolved.
- added...INTRON A increases the risk of hepatic decompensation and death in patients with cirrhosis. Any patient developing liver function abnormalities during treatment should be monitored closely and if appropriate, treatment should be discontinued.
- added bullet...Monitor hepatic function with serum bilirubin, ALT (alanine transaminase), AST (aspartate aminotransferase), alkaline phosphatase, and LDH (lactate dehydrogenase) at 2, 8 and 12 weeks following initiation of INTRON A, then every 6 months while receiving INTRON A. Permanently discontinue INTRON A for evidence of severe (Grade 3) hepatic injury or hepatic decompensation (Child-Pugh score >6 [class B and C]).
Post Marketing Experience
Respiratory, Thoracic, and Mediastinal Disorders
- pulmonary fibrosis added
- Updated in order to make it consistent with the Boxed Warning and Neuropsychiatric Disorders subsection under Warning section of the Package Insert.