"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2016
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