Monograph Details
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Infections & Infestations
> Viral infections
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REBETRON |
| Manufacturer |
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Schering Corporation |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Combination therapy (nucleoside analogue + interferon). |
| Generic Name |
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Ribavirin 200mg oral caps + interferon alfa-2b, recombinant, for SC inj (contains m-cresol) 3million IU/vial, 18 million IU/vial, or 18 million IU/pen. |
| Indications |
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Chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed after interferon alpha therapy. |
| Children |
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<18 yrs: not recommended. |
| Adults |
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Interferon-naive: treat for 24–48 weeks. Relapse: Treat for 24 weeks. ≥18yrs (≤75kg): interferon alfa-2b 3million IU three times weekly SC + ribavirin 400mg daily in AM and 600mg daily in PM. >75kg: interferon alfa-2b 3million IU three times weekly SC + ribavirin 600mg twice daily (AM & PM). 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). Temporarily reduce dose if mild depression occurs; discontinue if severe depression or suicidal ideation/attempt occurs. |
| Contraindications |
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Autoimmune hepatitis. Significant or unstable cardiac disease, hemoglobinopathies (e.g., thalassemia, sickle-cell anemia): not recommended. Male partners of pregnant women. Pregnancy (Cat.X). |
| Precautions |
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Severe renal impairment: not recommended. 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. Monitor for depression and for pulmonary symptoms (e.g., pulmonary infiltrates or pulmonary function impairment); discontinue if severe. Diabetes. Do pretreatment visual exam in diabetics and hypertensives. Discontinue if resistant thyroid abnormalities occur. Autoimmune disorders. Psoriasis. Organ transplant. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus or HIV infection. Maintain adequate hydration. Nursing mothers: not recommended. |
| Interactions |
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Caution with myelosuppressives. Ribavirin absorption reduced by antacids. |
| Adverse Reactions |
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Anemia and other hematological disorders, flu-like symptoms (headache, fatigue, myalgia, fever), cardiac events, pulmonary events (e.g., dyspnea, sinusitis), psychiatric effects (insomnia, depression, irritability, suicidal behavior), ocular events, dizziness, GI upset, alopecia, rash, pruritus, thyroid abnormalities, elevated bilirubin and uric acid levels. |
| Extra Text |
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Note: Report pregnancy in patient or partner by calling (800) 727-7064. |
| How Supplied |
Combination packs: Intron A 3million IU (6 vials) + Rebetol 200mg (70, 84, or 42 capsules)—1
Intron A 18million IU (1 multidose vial) + Rebetol 200mg (70, 84, or 42 capsules)—1
Intron A 18million IU (1 multidose pen) + Rebetol 200mg (70, 84, or 42 capsules)—1 |
| Additional Resources |
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• Related Prescribing Note |
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