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COPEGUS
Viral infections
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Drug Name:

COPEGUS Rx

Generic Name and Formulations:
Ribavirin 200mg; tabs.

Company:
Roche Diagnostics Corp.

Therapeutic Use:

Indications for COPEGUS:

Chronic hepatitis C, in combination with peginterferon alfa-2a (Pegasys), in patients ≥5yrs of age with compensated liver disease previously untreated with interferon alpha, including patients co-infected with HIV.

Adult:

Take with food in 2 divided doses. ≥18yrs: Genotype 1, 4: (<75kg): 1g/day for 48 weeks; (≥75kg): 1.2g/day for 48 weeks. Genotype 2, 3: 800mg/day for 24 weeks. HIV co-infection: 800mg/day for 48 weeks. Renal impairment (CrCl 30–50mL/min): 200mg and 400mg alternating every other day; (CrCl <30mL/min) or hemodialysis: 200mg/day. Reduce dose or discontinue if severe reactions or hematologic abnormalities occur; see full labeling.

Children:

Take with food in 2 divided doses. <5yrs: not established. ≥5yrs (23–33kg): 400mg/day; (34–46kg): 600mg/day; (47–59kg): 800mg/day; (60–74kg): 1g/day; (≥75kg): 1.2g/day. Treat for 48 weeks (Genotype 1, 4) or 24 weeks (Genotype 2, 3). Reduce dose or discontinue if severe reactions or hematologic abnormalities occur; see full labeling.

Contraindications:

Hemoglobinopathies (eg, thalassemia, sickle-cell anemia). Pregnancy (Cat.X). Male partners of pregnant women. Concomitant didanosine. With Pegasys: autoimmune hepatitis, hepatic decompensation in cirrhotic patients before therapy.

Warnings/Precautions:

Not for use as monotherapy. Risk of severe hemolytic anemia. Significant or unstable cardiac disease: not recommended. Assess for underlying cardiac disease prior to initiation. Pre-existing cardiac disease: do ECG prior to therapy and monitor. Women of childbearing potential: obtain negative pregnancy test immediately before starting therapy. Women of childbearing potential and men: use 2 forms of effective contraception during and for 6 months following treatment. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, renal function, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Monitor hepatic function during therapy. Discontinue if cardiovascular status deteriorates, hepatic decompensation, pulmonary disorders, severe hypersensitivity or skin reactions, or pancreatitis occurs. Psychiatric disorders. Autoimmune disorders. Organ transplant. Nonresponders to interferon. Co-infection with hepatitis B virus. Maintain adequate hydration. Nursing mothers: not recommended.

Interactions:

Caution with NRTIs (eg, lamivudine, stavudine, zidovudine); monitor for toxicities. Concomitant azathioprine; may induce severe pancytopenia and increase risk of myelotoxicity (monitor CBCs). Avoid alcohol.

Pharmacological Class:

Nucleoside analogue.

Adverse Reactions:

Fatigue/asthenia, pyrexia, nausea, vomiting, myalgia, headache; hemolytic anemia, bone marrow suppression, cardiac events, pulmonary events, psychiatric effects, skin disorders, hepatic failure, pancreatitis, growth inhibition (children).

Note:

Register pregnant women exposed to Copegus by calling (800) 593–2214 (see Contraindications).

How Supplied:

Tabs—168

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