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COPEGUS
Viral infections
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Drug Name:

COPEGUS Rx

Generic Name and Formulations:
Ribavirin 200mg; tabs.

Company:
Roche Laboratories



Therapeutic Use:

Indications for COPEGUS:

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

Adult Dose for COPEGUS:

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 patients: 800mg/day for 48 weeks. Reduce dose or discontinue if severe reactions or hematologic abnormalities occur. Cardiac disease: discontinue if cardiovascular status deteriorates; reduce dose or discontinue if hemoglobin levels decrease; see literature. Renal impairment (CrCl<50mL/min): not recommended.

Children's Dose for COPEGUS:

≤18yrs: not recommended.

Pharmacological Class:

Nucleoside analogue.

Contraindications:

Autoimmune hepatitis. Significant or unstable cardiac disease, hemoglobinopathies (eg, thalassemia, sickle-cell anemia): not recommended. Renal dysfunction (CrCl <50mL/min). Hepatic decompensation before or during therapy. Male partners of pregnant women. Pregnancy (Cat. X).

Warnings/Precautions:

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), white counts with differential, platelet counts, blood chemistry, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Suspend or discontinue if cardiovascular status deteriorates. Psychiatric disorders. Autoimmune disorders. Organ transplant. Pancreatitis. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus. Maintain adequate hydration. Nursing mothers: not recommended.

Interactions:

Avoid alcohol. May antagonize stavudine, zidovudine. Caution with NRTIs; monitor for toxicities. Concomitant didanosine: not recommended.

Adverse Reactions:

Anemia and other hematological disorders, flu-like symptoms, cardiac events, pulmonary events, psychiatric effects, dizziness, GI upset, weight loss, alopecia, rash, pruritus, diabetes, pancreatitis.

Note:

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

How Supplied:

Tabs—168

COPEGUS

  • 200mg tablets (Qty:6)
  • appx. price $119.00
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