• Ribavirin monotherapy is not effective for treatment of chronic hepatitis C virus (HCV) infection and should not be used alone for this indication.
• The principal toxicity of oral ribavirin is hemolytic anemia which may result in worsening of cardiac disease and has resulted in fatal and nonfatal MI. Patients with a history of substantial or unstable cardiac disease should not be given ribavirin.
• Teratogenic and/or embryocidal effects demonstrated. Ribavirin has a long half-life and may persist in nonplasma compartments for as long as 6 months. Contraindicated in pregnant women and in male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during and for 6 months following ribavirin therapy in female patients and in female partners of male patients receiving ribavirin. At least 2 reliable forms of contraception must be used during and for 6 months following completion of treatment.
• Initiation of aerosolized ribavirin (given by nasal or oral inhalation) in infants has resulted in sudden deterioration of respiratory function. Monitor respiratory function carefully. If sudden deterioration of respiratory function occurs, discontinue therapy. Reinstitute with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.
• Ribavirin for nasal or oral inhalation is not indicated in adults.
• Administer aerosolized ribavirin under the supervision of and by qualified clinicians and support staff experienced with the specific ventilator and mode of administration. Attention must be directed to procedures that minimize accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressure.

REMS:

FDA approved a REMS for ribavirin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).