PEG-Intron, peginterferon alfa-2b, is indicated for use alone or in combination with REBETOL (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

There are no safety and efficacy data on treatment for longer than 1 year. A patient should self-inject PEG-Intron only if it has been determined 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.

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.

The recommended dose of PEG-Intron regimen is 1.0 mg/kg/week subcutaneously for one 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 below).

Table 4 Recommended PEG-Intron Monotherapy Dosing

* When reconstituted as directed

When administered in combination with REBETOL, the recommended dose of PEG-Intron is 1.5 micrograms/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.)

Table 5. Recommended PEG-Intron Combination Therapy Dosing

* When reconstituted as directed

The recommended dose of REBETOL is 800 mg/day in 2 divided doses: two capsules (400 mg) with break-fast and two capsules (400 mg) with dinner. REBETOL should not be used in patients with creatinine clear-ance <50 mL/min.

If a serious adverse reaction develops during the course of treatment (see WARNINGS) 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. Dose reduction of PEG-Intron may be accomplished by utilizing a lower dose strength as shown in Table 8 or 9. For vials, 50% dose reduction may also be accomplished by reducing the volume administered by one-half without changing the dose strength.

In the combination therapy trial dose reductions occurred among 42% of patients receiving PEG-Intron 1.5 mg/kg/REBETOL 800 mg daily including 57% of those patients weighing 60 kg or less (see ADVERSE REACTIONS).

^{Table 6: Guidelines for Modification or Discontinuation of PEG-Intron or PEG-Intron/REBETOL and for Scheduling Visits for Patients with Depression}

¹See DSM-IV for definitions

^{Table 7. Guidelines for Dose Modification and Discontinuation of PEG-Intron or PEG-Intron/REBETOL for Hematologic Toxicity}

* For patients with a history of stable cardiac disease receiving PEG-Intron in combination with ribavirin, the PEG-Intron dose should be reduced by half and the ribavirin dose by 200 mg/day if a >2 g/dL decrease in hemoglobin is observed during any 4-week period. Both PEG-Intron and ribavirin should be permanently discontinued if patients have hemoglobin levels <12 g/dL after this ribavirin dose reduction.

^{Table 8: Reduced PEG-Intron Dose (0.5 mg /kg) for (1.0 mg /kg) Monotherapy}

* Must use vial. Minimum delivery for Redipen 0.3 mL
** When reconstituted as directed

^{Table 9. Reduced PEG-Intron Dose (0.75 mg/kg) for (1.5 mg/kg) Combination Therapy}

* Must use vial. Minimum delivery for Redipen 0.3 mL
** When reconstituted as directed

In patients with moderate renal dysfunction (creatinine clearance 30-50 mL/min), the PEG-Intron dose should be reduced by 25%. Patients with severe renal dysfunction (creatinine clearance 10-29 mL/min) including those on hemodialysis, should have the PEG-Intron dose reduced by 50%. If renal function decreases during treatment, PEG-Intron therapy should be discontinued.

PEG-Intron Redipen^Ò consists of a dual-chamber glass cartridge with sterile, lyophilized peginterferon alfa-2b in the active chamber and Sterile Water for Injection, USP in the diluent chamber. The PEG-Intron in the glass cartridge should appear as a white to off-white tablet-shaped solid that is whole or in pieces, or powder. To reconstitute the lyophilized peginterferon alfa-2b in the Redipen^Ò , hold the Redipen^Ò upright (dose button down) and press the two halves of the pen together until there is an audible click. Gently invert the pen to mix the solution. DO NOT SHAKE. The reconstituted solution has a concentration of either 50 mg per 0.5 mL, 80 mg per 0.5 mL, 120 mg per 0.5 mL, or 150 mg per 0.5 mL for a single subcutaneous injection. Visually inspect the solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless. Do not use if the solution is discolored or cloudy, or if particulates are present.

Keeping the pen upright, attach the supplied needle and select the appropriate PEG-Intron dose by pulling back on the dosing button until the dark bands are visible and turning the button until the dark band is aligned with the correct dose. The prepared PEG-Intron solution is to be injected subcutaneously.

The PEG-Intron Redipen^Ò is a single use pen and does not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2° -8° C (see Storage). DO NOT REUSE THE REDIPEN^Ò. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

Two B-D Safety-LokÒ syringes are provided in the package; one syringe is for the reconstitution steps and one for the patient injection. There is a plastic safety sleeve to be pulled over the needle after use. The syringe locks with an audible click when the green stripe on the safety sleeve covers the red stripe on the needle. Instructions for the preparation and administration of PEG-Intron Powder for Injection are provided below.

Reconstitute the PEG-Intron lyophilized product with only 0.7 mL of 1.25 mL of supplied diluent (Sterile Water for Injection, USP). The diluent vial is for single use only. The remaining diluent should be discarded. No other medications should be added to solutions containing PEG-Intron, and PEG-Intron should not be reconstituted with other diluents. Swirl gently to hasten complete dissolution of the powder. The reconstituted solution should be clear and colorless. Visually inspect the solution for particulate matter and discoloration prior to administration. The solution should not be used if discolored or cloudy, or if particulates are present.

The appropriate PEG-Intron dose should be withdrawn and injected subcutaneously. PEG-Intron vials are for single use only and do not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2-8° C (see Storage). DO NOT REUSE THE VIAL. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

After preparation and administration of the PEG-Intron for injection, it is essential to follow the state and/or local procedures for proper disposal of syringes, needles, and the Redipen^Ò . A puncture-resistant container should be used for disposal. Patients should be instructed in how to properly dispose of used syringes, needles, or the Redipen^Ò and be cautioned against the reuse of these items.

PEG-Intron Redipen^Ò should be stored at 2°C to 8°C (36° to 46°F).

After reconstitution, the solution should be used immediately, but may be stored up to 24 hours at 2° to 8°C (36° to 46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE.

PEG-Intron should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. After reconstitution with supplied Diluent the solution should be used immediately, but may be stored up to 24 hours at 2° to 8° C (36° to 46°F). The reconstituted solution contains no preservative, is clear and colorless. DO NOT FREEZE.

PEG-Intron Vials

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