DOSAGE AND ADMINISTRATION
The recommended dose of COPEGUS tablets is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.
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 (see Table 5).
In the pivotal clinical trials, patients were instructed to take COPEGUS with food; therefore, patients are advised to take COPEGUS with food.
Table 5 PEGASYS and COPEGUS Dosing Recommendations
|Genotype||PEGASYS Dose||COPEGUS Dose||Duration|
|Genotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.|
|Genotypes 1, 4||180 µg||<75 kg = 1000 mg||48 weeks|
|≥75 kg = 1200 mg||48 weeks|
|Genotypes 2, 3||180 µg||800 mg||24 weeks|
CHC with HIV Coinfection
The recommended dose for hepatitis C in HCV/HIV coinfected patients is PEGASYS 180 µg sc once weekly and COPEGUS 800 mg po daily for a total of 48 weeks, regardless of genotype.
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.
COPEGUS should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).
Table 6 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|
Once COPEGUS has been withheld due to either 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 its original assigned dose (1000 mg to 1200 mg).
COPEGUS should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and CLINICAL PHARMACOLOGY: Special Populations).