Patients receiving PEG-Intron alone or in combination with REBETOL should be directed in its appropriate use, informed of the benefits and risks associated with treatment, and referred to the MEDICATION GUIDES for PEG-Intron and, if applicable, REBETOL (ribavirin, USP).

Patients must be informed that REBETOL may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during treatment with combination PEG-Intron/REBETOL therapy and for 6 months post-therapy. Combination PEG-Intron/ REBETOL therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. It is recommended that patients undergo monthly pregnancy tests during therapy and for 6 months post-therapy. (See CONTRAINDICATIONS and REBETOL package insert.)

Patients should be informed that there are no data regarding whether PEG-Intron therapy will prevent transmission of HCV infection to others. Also, it is not known if treatment with PEG-Intron will cure hepatitis C or prevent cirrhosis, liver failure, or liver cancer that may be the result of infection with the hepatitis C virus.

Patients should be advised that laboratory evaluations are required before starting therapy and periodically thereafter (see Laboratory Tests). It is advised that patients be well hydrated, especially during the initial stages of treatment. "Flu-like" symptoms associated with administration of PEG-Intron may be minimized by bedtime administration of PEG-Intron or by use of antipyretics.

Patients should be advised to use a puncture-resistant container for the disposal of used syringes, needles, and the Redipen^Ò . The full container should be disposed of in accordance with state and local laws. Patients should be thoroughly instructed in the importance of proper disposal. Patients should also be cautioned against reusing or sharing needles, syringes, or the Redipen^Ò .

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