Peginterferon alfa-2b (Sylatron, Schering) is an interferon immunotherapeutic agent approved for the treatment of metastatic melanoma. The drug is administered as a weekly subcutaneous injection. This section outlines the common adverse reactions, warnings and precautions, drug interactions and other contraindications that are associated with peginterferon alfa-2b.
Topics Covered:
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Peginterferon alfa-2b common adverse reactions
Adverse reactions reported by at least 60% of clinical trial patients included fatigue, fever, headache, anorexia, myalgia, nausea, chills, injection site reaction and elevated liver enzymes (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]).
Peginterferon alfa-2b warnings and precautions
Life-threatening and fatal neuropsychiatric reactions may occur with peginterferon alfa-2b use, including suicide, suicidal ideation, homicidal ideation and depression.
Depression was reported by 59% of patients in clinical trials. Post-marketing neuropsychiatric reactions have also been reported, including hallucinations, psychosis, aggression, bipolar mania and encephalopathy. Patients taking peginterferon alfa-2b should be advised to report any of these symptoms to their health care provider, and providers should monitor their patients for these symptoms. Suicidal or homicidal ideation should result in immediate discontinuation of peginterferon alfa-2b.)
Additional serious adverse events associated with peginterferon alfa-2b treatment include:
- cardiovascular reactions, including myocardial infarction and arrhythmias;
- decreased visual acuity and blindness;
- liver failure; and
- hyperthyroidism, hypothyroidism and diabetes mellitus.
Peginterferon alfa-2b drug interactions and other contraindications
Patients taking drugs with a narrow therapeutic range that are metabolized by cytochrome P450 should be closely monitored while on peginterferon alfa-2b therapy. Because of the risk for liver toxicity, liver function should be monitored throughout treatment, and peginterferon alfa-2b should be discontinued in patients showing signs of liver toxicity or failure.
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