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Copegus

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Copegus

Indications
Dosage
How Supplied

INDICATIONS

COPEGUS in combination with PEGASYS (peginterferon alfa-2a) is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

The following points should be considered when initiating COPEGUS combination therapy with PEGASYS:

  • This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm³.
  • This indication is based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose.
  • Safety and efficacy data are not available for treatment longer than 48 weeks.
  • The safety and efficacy of COPEGUS and PEGASYS therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy.
  • The safety and efficacy of COPEGUS therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. COPEGUS should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered.

DOSAGE AND ADMINISTRATION

COPEGUS should be taken with food. COPEGUS should be given in combination with PEGASYS; it is important to note that COPEGUS should never be given as monotherapy. See PEGASYS Package Insert for all instructions regarding PEGASYS dosing and administration.

Chronic Hepatitis C Monoinfection

Adult Patients

The recommended dose of COPEGUS tablets is provided in Table 1. 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 1).

Table 1 : PEGASYS and COPEGUS Dosing Recommendations

Hepatitis C Virus (HCV) Genotype PEGASYS Dose* (once weekly) COPEGUS Dose (daily) Duration
Genotypes 1, 4 180 mcg < 75 kg = 1000 mg 48 weeks
≥ 75 kg = 1200 mg 48 weeks
Genotypes 2, 3 180 mcg 800 mg 24 weeks
Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10).
Data on genotypes 5 and 6 are insufficient for dosing recommendations.
*See PEGASYS Package Insert for further details on PEGASYS dosing and administration, including dose modification in patients with renal impairment.

Pediatric Patients

PEGASYS is administered as 180 mcg/1.73m² x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.

COPEGUS should be given in combination with PEGASYS. COPEGUS is available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for COPEGUS are provided in Table 2. Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through the completion of therapy.

Table 2 : COPEGUS Dosing Recommendations for Pediatric Patients

Body Weight in kilograms (kg) COPEGUS Daily Dose* COPEGUS Number of Tablets
23 – 33 400 mg/day 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M.
34 – 46 600 mg/day 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M.
47 – 59 800 mg/day 2 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
60 – 74 1000 mg/day 2 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
≥ 75 1200 mg/day 3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
*approximately 15 mg/kg/day

Chronic Hepatitis C with HIV Coinfection

Adult Patients

The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is PEGASYS 180 mcg subcutaneous once weekly and COPEGUS 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

Dose Modifications

Adult and Pediatric Patients

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 or decrease in severity. If intolerance persists after dose adjustment, COPEGUS/PEGASYS therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.

COPEGUS should be administered with caution to patients with pre-existing cardiac disease. 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 AND PRECAUTIONS].

Table 3 : COPEGUS Dose Modification Guidelines in Adults and Pediatrics

Body weight in kilograms (kg) Laboratory Values
Hemoglobin < 10 g/dL in patients with no cardiac disease, or
Decrease in hemoglobin of ≥ 2 g/dL during any 4 week period in patients with history of stable cardiac disease
Hemoglobin < 8.5 g/dL in patients with no cardiac disease, or
Hemoglobin < 12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease
Adult Patients older than 18 years of age
  Any weight 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M. Discontinue COPEGUS
Pediatric Patients 5 to 18 years of age
  23 – 33 kg 1 x 200 mg tablet A.M. Discontinue COPEGUS
  34 – 46 kg 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M.
  47 – 59 kg 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M.
  60 – 74 kg 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M.
   ≥ 75 kg 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M.

The guidelines for COPEGUS dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.

Adult Patients

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

Pediatric Patients

Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in COPEGUS dose to the original dose may be attempted depending upon the physician's judgment. If COPEGUS has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart COPEGUS at one-half the full dose.

Renal Impairment

The total daily dose of COPEGUS should be reduced for patients with creatinine clearance less than or equal to 50 mL/min; and the weekly dose of PEGASYS should be reduced for creatinine clearance less than 30 mL/min as follows in Table 4 [see Use In Specific Populations, Pharmacokinetics, and PEGASYS Package Insert].

Table 4 : Dosage Modification for Renal Impairment

Creatinine Clearance PEGASYS Dose (once weekly) COPEGUS Dose (daily)
30 to 50 mL/min 180 mcg Alternating doses, 200 mg and 400 mg every other day
Less than 30 mL/min 135 mcg 200 mg daily
Hemodialysis 135 mcg 200 mg daily

The dose of COPEGUS should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, COPEGUS should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting COPEGUS, COPEGUS/PEGASYS therapy should be discontinued.

No data are available for pediatric subjects with renal impairment.

Discontinuation of Dosing

Discontinuation of PEGASYS/COPEGUS therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

PEGASYS/COPEGUS therapy should be discontinued in patients who develop hepatic decompensation during treatment [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

COPEGUS (ribavirin) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin.

COPEGUS® (ribavirin) is available as tablets for oral administration. Each tablet contains 200 mg of ribavirin and is light pink to pink colored, flat, oval-shaped, film-coated, and engraved with RIB 200 on one side and ROCHE on the other side. They are packaged as bottle of 168 tablets (NDC 0004-0086-94).

Storage and Handling

Store the COPEGUS®Tablets bottle at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F) [see WARNINGS AND PRECAUTIONS]. Keep bottle tightly closed.

Distributed by: Genentech USA, INC. A Member of the Roche Group 1 DNA Way, South San Francisco, CA 94080-4990. Revised: 02/2013

Last reviewed on RxList: 3/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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