"The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.
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There is limited experience with overdosage. Postmarketing surveillance includes reports of patients receiving a single dose as great as 10 times the recommended dose. In general, the primary effects of an overdose are consistent with the effects seen with therapeutic doses of interferon alfa-2b. Hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with single administration overdoses and/or with longer durations of treatment than prescribed (see ADVERSE REACTIONS). Toxic effects after ingestion of interferon alfa-2b are not expected because interferons are poorly absorbed orally. Consultation with a poison center is recommended.
INTRON® A is contraindicated in patients with:
- Hypersensitivity to interferon alpha or any component of the product
- Autoimmune hepatitis
- Decompensated liver disease
INTRON A and REBETOL® combination therapy is additionally contraindicated in:
- Patients with hypersensitivity to ribavirin or any other component of the product
- Women who are pregnant
- Men whose female partners are pregnant
- Patients with hemoglobinopathies (e.g., thalassemia major, sickle cell anemia)
- Patients with creatinine clearance less than 50 mL/min. See REBETOL prescribing information for additional information.
Last reviewed on RxList: 9/25/2014
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