There is limited experience with overdosage. Acute ingestion of up to 20 grams 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 events 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.

There is no specific antidote for INTRON A or REBETOL overdose, and hemodialysis and peritoneal dialysis are not effective treatment of overdose of either agent.

Pregnancy

REBETOL Capsules and Oral Solution may cause birth defects and/or death of the exposed fetus. REBETOL therapy is contraindicated for use in women who are pregnant or in men whose female partners are pregnant. (See WARNINGS, PRECAUTIONS-Information for Patients and Pregnancy Category X.)

REBETOL Capsules and Oral Solution are contraindicated in patients with a history of hypersensitivity to ribavirin or any component of the capsule.

Patients with autoimmune hepatitis must not be treated with combination REBETOL/INTRON A therapy because using these medicines can make the hepatitis worse.

Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) should not be treated with REBETOL Capsules or Oral Solution.

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