PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

There are no safety and efficacy data on treatment of chronic hepatitis C or hepatitis B for longer than 48 weeks. For patients with hepatitis C, consideration should be given to discontinuing therapy after 12 to 24 weeks of therapy if the patient has failed to demonstrate an early virologic response defined as undetectable HCV RNA or at least a 2log¹⁰ reduction from baseline in HCV RNA titer by 12 weeks of therapy (see CLINICAL STUDIES).

A patient should self-inject PEGASYS 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 provided to him/her (see illustrated PEGASYS MEDICATION GUIDE for directions on injection site preparation and injection instructions).

PEGASYS should be inspected visually for particulate matter and discoloration before administration, and not used if particulate matter is visible or product is discolored.Vials and prefilled syringes with particulate matter or discoloration should be returned to the pharmacist.

The recommended dose of PEGASYS monotherapy for chronic hepatitis C is 180 mg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.

The recommended dose of PEGASYS when used in combination with ribavirin for chronic hepatitis C is 180 mg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly. The recommended dose of COPEGUS and duration for PEGASYS/COPEGUS therapy is based on viral genotype (see Table 7).

The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen.

Since COPEGUS absorption increases when administered with a meal, patients are advised to take COPEGUS with food.

Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 3).
Data on genotypes 5 and 6 are insufficient for dosing recommendations.

The recommended dose of PEGASYS monotherapy for chronic hepatitis C in patients coinfected with HIV is 180 mg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.

The recommended dose when used in combination with ribavirin is PEGASYS 180 mg sc once weekly and COPEGUS 800 mg po daily given in two divided doses for a total of 48 weeks, regardless of genotype.

Since COPEGUS absorption increases when administered with a meal, patients are advised to take COPEGUS with food.

The recommended dose of PEGASYS monotherapy for hepatitis B is 180 mg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.

General

When dose modification is required for moderate to severe adverse reactions (clinical and/or laboratory), initial dose reduction to 135 mg (which is 0.75 mL for the vials or adjustment to the corresponding graduation mark for the syringes) is generally adequate. However, in some cases,dose reduction to 90 mg (which is 0.5 mL for the vials or adjustment to the corresponding graduation mark for the syringes) may be needed.

Following improvement of the adverse reaction, re-escalation of the dose may be considered (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).

Hematological

Psychiatric: Depression

Renal Function

In patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

Liver Function

If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be immediately discontinued.

In chronic hepatitis C patients with progressive ALT increases above baseline values, the dose of PEGASYS should be reduced to 135 mg and more frequent monitoring of liver function should be performed. After PEGASYS dose reduction or withholding, therapy can be resumed after ALT flares subside.

In chronic hepatitis B patients with elevations in ALT (>5 x ULN), more frequent monitoring of liver function should be performed and consideration should be given to either reducing the dose of PEGASYS to 135 mg or temporarily discontinuing treatment. After PEGASYS dose reduction or withholding, therapy can be resumed after ALT flares subside.

In patients with persistent, severe (ALT >10 times above the upper limit of normal) hepatitis B flares, consideration should be given to discontinuation of treatment.

*One 200 mg tablet in the morning and two 200 mg tablets in the evening.

Once COPEGUS has been withheld due to a laboratory abnormality or clinical manifestation, an attempt may be made to restart COPEGUS at 600 mg daily and further increase the dose to 800 mg daily depending upon the physicians judgment. However, it is not recommended that COPEGUS be increased to the original dose (1000 mg or 1200 mg).

Renal Impairment

COPEGUS should not be used in patients with creatinine clearance <50 mL/min (see CLINICAL PHARMACOLOGY, WARNINGS and COPEGUS Package Insert).

Single Dose Vial

Each PEGASYS (peginterferon alfa-2a) 180 mg single use, clear glass vial provides 1.0 mL containing 180 mg peginterferon alfa-2a for sc injection. Each package contains 1 vial (NDC 0004-0350-09).

Four vials of PEGASYS (peginterferon alfa-2a), 180 mg single use, clear glass vials, in a box with 4 syringes and 8 alcohol swabs (NDC 0004-0350-39). Each syringe is a 1 mL (1 cc) volume syringe supplied with a 27-gauge, ½-inch needle with needle-stick protection device.

Four prefilled syringes of PEGASYS (peginterferon alfa-2a), 180 mg single use, graduated, clear glass prefilled syringes, in a box with 4 needles and 4 alcohol swabs (NDC 0004-0352-39). Each syringe is a 0.5 mL (½ cc) volume syringe supplied with a 27-gauge, ½-inch needle with needle-stick protection device.

Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Vials and prefilled syringes are for single use only. Discard any unused portion.

REBETRON, REBETROL, and INTRON are registered trademarks of Schering Corporation, Revised: May 2005

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