Dosage and Administration

Safety and efficacy data are only available for treatment periods of up to 1 year. A patient should self-inject PEG-INTRON® (Peginterferon alfa-2b) Powder for Injection only if the physician determines that it is appropriate and the patient agrees to medical follow-up as necessary and training in proper injection technique has been given to him/her. (See illustrated MEDICATION GUIDE for instructions.)

It is recommended that patients receiving PEG-INTRON®, alone or in combination with ribavirin, be discontinued from therapy if HCV viral levels remain high after 6 months of therapy.

PEG-INTRON Monotherapy

The recommended dose of PEG-INTRON regimen is 1.0 µg/kg/week subcutaneously for 1 year. The dose should be administered on the same day of the week. The volume of PEG-INTRON® to be injected depends on the patient weight (see Table 4 in PEG-INTRON Prescribing Information).

PEG-INTRON/REBETOL® (Ribavirin, USP) Capsules Combination Therapy

When administered in combination with REBETOL®, the recommended dose of PEG-INTRON® is 1.5 µg/kg/week. The volume of PEG-INTRON® to be injected depends on the strength of PEG-INTRON® and patient's body weight (see Table 5 in PEG-INTRON Prescribing Information).

The recommended dose of REBETOL® is 800 mg/day in 2 divided doses: two capsules (400 mg) with breakfast and two capsules (400 mg) with dinner. REBETOL® should not be used in patients with creatinine clearance <50mL/min (see REBETOL Prescribing Information).

Dose Reduction

If a serious adverse reaction develops during the course of treatment (see WARNINGS in PEG-INTRON Prescribing Information), discontinue or modify the dosage of PEG-INTRON® and/or REBETOL® until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. For guidelines for dose modifications and discontinuation based on laboratory parameters, see Tables 6 and 7 in PEG-INTRON Prescribing Information. In the combination therapy trial dose reductions occurred among 42% of patients receiving PEG-INTRON® 1.5 µg/kg/REBETOL® 800 mg daily including 57% of those patients weighing 60 kg or less (see ADVERSE REACTIONS in PEG-INTRON Prescribing Information).

IMPORTANT: PEG-INTRON® is packaged as either the PEG-INTRON REDIPEN® Single-Dose Delivery System comprised of a pen body containing one dual-chamber cartridge-one with PEG-INTRON powder and the other containing sterile water diluent; or PEG-INTRON vials comprised of one vial of PEG-INTRON Powder for Injection and one vial of sterile water diluent. The supplied diluent contains no preservative, is for single use only, and any remaining diluent should be discarded. Both forms are for subcutaneous injection. The reconstituted solution in both forms has no preservative and should be used immediately, but may be stored up to 24 hours at 2º to 8ºC (36º to 46ºF).

For more on dosage and administration, and other prescription information, see PEG-INTRON Prescribing Information.