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 in the complete product information).
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.
(For complete dosing information, see DOSAGE AND ADMINISTRATION in the complete product information).
Chronic Hepatitis C
PEGASYS Monotherapy
The recommended dose of PEGASYS monotherapy for chronic hepatitis C is 180 µg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
PEGASYS and COPEGUS® (Ribavirin, USP) Combination Therapy
The recommended dose of PEGASYS when used in combination with ribavirin for chronic hepatitis C is 180 µg (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.
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 (eg, 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.
Chronic Hepatitis C With HIV Coinfection
PEGASYS Monotherapy
The recommended dose of PEGASYS monotherapy for chronic hepatitis C in patients coinfected with HIV is 180 µg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
PEGASYS/COPEGUS Combination Therapy
The recommended dose when used in combination with ribavirin is PEGASYS 180 µg administered subcutaneously in the abdomen or thigh once weekly and COPEGUS 800 mg administered orally 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.
Chronic Hepatitis B
PEGASYS Monotherapy
The recommended dose of PEGASYS monotherapy for hepatitis B is 180 µg (1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
Dose Modifications
If severe adverse reactions or laboratory abnormalities develop during combination COPEGUS/PEGASYS therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, COPEGUS/PEGASYS therapy should be discontinued.
PEGASYS
General
When dose modification is required for moderate to severe adverse reactions (clinical and/or laboratory), initial dose reduction to 135 µg (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 µg (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 in the complete product information).
Hematological
PEGASYS Hematological Dose Modification Guidelines
| Laboratory Values |
Reduce PEGASYS Dose to: |
Discontinue PEGASYS if: |
| ANC ≥750/mm3 ANC <750/mm3 |
Maintain
180 µg.Reduce
to 135 µg. |
ANC <500/mm3, treatment should be suspended until ANC values return to more than 1000/mm3. Reinstitute at 90 µg and monitor ANC. |
| Platelet ≥50,000/mm3 Platelet <50,000/mm3 |
Maintain
180 µg.Reduce
to 90 µg. |
Platelet count <25,000/mm3 |
Psychiatric: Depression
Guidelines for Modification or Discontinuation of PEGASYS
and for Scheduling Visits for Patients With Depression
| Depression Severity |
Initial Management
(4-8 weeks) |
Depression |
| |
Dose modification |
Visit schedule |
Remains stable |
Improves |
Worsens |
| Mild |
No change |
Evaluate once weekly by visit and/or phone. |
Continue weekly visit schedule. |
Resume normal visit schedule. |
(See moderate or severe depression.) |
| Moderate |
Decrease PEGASYS dose to 135 µg (in some cases dose reduction to 90 µg may be needed). |
Evaluate once weekly (office visit at least every other week). |
Consider psychiatric consultation. Continue reduced dosing. |
If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced dosing or return to normal dose. |
(See severe depression.) |
| Severe |
Discontinue PEGASYS permanently. |
Obtain immediate psychiatric consultation. |
Psychiatric therapy necessary. |
Renal Function
In patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 µg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.
PEGASYS should be used with caution in patients with creatinine clearance <50 mL/min. COPEGUS should not be used in patients with creatinine clearance <50 mL/min.
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 µg 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 µg 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.
COPEGUS
COPEGUS Dosage Modification Guidelines
| Laboratory Values |
Reduce Only COPEGUS Dose to 600 mg/day* if: |
Discontinue COPEGUS if: |
| Hemoglobin in patients with no cardiac disease |
<10 g/dL |
<8.5 g/dL |
| Hemoglobin in patients with history of stable cardiac disease |
≥2 g/dL decrease in hemoglobin during any 4-week period treatment |
<12 g/dL despite 4 weeks at reduced dose |
*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 physician's judgment. However, it is not recommended that COPEGUS be increased to the original dose (1000 mg or 1200 mg).
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