"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
There is limited experience with overdosage. Acute ingestion of up to 20 g of REBETOL capsules, INTRON A ingestion of up to 120 million units, and subcutaneous doses of INTRON A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse reactions related to the therapeutic use of INTRON A and REBETOL. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of INTRON A that exceed dosing recommendations.
REBETOL combination therapy is contraindicated in:
- women who are pregnant. REBETOL may cause fetal harm when administered to a pregnant woman. REBETOL is contraindicated in women who are or may become pregnant. If REBETOL is used during pregnancy, or if the patient becomes pregnant while taking REBETOL, the patient should be apprised of the potential hazard to her fetus [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and PATIENT INFORMATION]
- men whose female partners are pregnant
- patients with known hypersensitivity reactions such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product
- patients with autoimmune hepatitis
- patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
- patients with creatinine clearance less than 50 mL/min. [see Use in Specific Populations and CLINICAL PHARMACOLOGY]
- Coadministration of REBETOL and didanosine is contraindicated because exposure to the active metabolite of didanosine (dideoxyadenosine 5'-triphosphate) is increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving didanosine in combination with ribavirin [see DRUG INTERACTIONS].
Last reviewed on RxList: 6/3/2015
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