Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)
WARNINGS AND PRECAUTIONS
- Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.
- PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
- Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation or aggressive behavior towards others is identified, discontinue treatment with PegIntron and follow the patient closely, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted [see Dosage and Administration (2.3)]. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.
Respiratory, Thoracic, and Mediastinal Disorders
- added...pulmonary fibrosis
- ......are pregnant or plan to become pregnant. PegIntron may harm your unborn baby. You should use effective birth control during treatment with PegIntron. Talk to your healthcare provider about birth control choices for you during treatment with PegIntron. Tell your healthcare provider if you become pregnant during treatment with PegIntron.
- Updated in order to make it consistent with the Boxed Warning, Warnings and Precautions, and Neuropsychiatric Events subsection (section 5.2) of the Package Insert.