Rebetol

/ MSD

The dose of Rebetol is based on patient body weight. Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Adult patients: The dose of Rebetol is based on patient body weight (See prescribing information for full details). Rebetol must be used in combination with either peginterferon alfa-2b (1.5 micrograms/kg/week) or interferon alfa-2b (3 million international units [MIU] three times a week). The choice of combination regimen is based on the characteristics of the patient. The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient.
See prescribing information for full details.
Use in renal impairment: The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients. Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol. Patients with creatinine clearance < 50 ml/minute must not be treated with Rebetol. Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia. If serum creatinine rises to > 2.0 mg/dl, Rebetol and
peginterferon alfa-2b/interferon alfa-2b must be discontinued.
Use in hepatic impairment: No pharmacokinetic interaction appears between ribavirin and hepatic function. Therefore, no dose adjustment of Rebetol is required in patients with hepatic impairment. The use of ribavirin is contraindicated in patients with severe hepatic impairment or decompensated cirrhosis.
Use in the elderly (≥ 65 years of age): There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin. However, as in younger patients, renal function must be determined prior to administration of Rebetol.
Patients co-infected with HCV/HIV: Patients taking nucleoside reverse transcriptase inhibitor (NRTI) treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation. Please refer also to the relevant product information for antiretroviral medicinal products.
See prescribing information for full details.

In combination with interferon Alfa-2b comb. (intron A) inject. for chronic hepatitis C in 18 years or older with compensated liver disease previously untreated with Alfa interferon or following relapse after treatment with Alfa interferon.

Pregnancy and lactation, hypersensitivity, pre-existing cardiac disease, haemoglobinopathies, severe, debilitating medicdbal conditions, history of severe psychiatric condition, severe hepatic dysfunction, autoimmune hepatitis, pre-existing thyroid disease.

Ribavirin as monotherapy is not effective. Use Rebetol together with interferon alfa-2b solution for injection. Teratogenic risk. Male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment and for 7 months after treatment has been concluded. Men whose partners are pregnant must be instructed to use a condom. A history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored. Liver function must be monitored closely.

Rebetol + interferon alfa-2b. Injection site inflammation. Dry mouth, sweating, asthenia, chest pain, fatigue, fever, headache, influenza-like symptoms, malaise, rigors, right upper quadrant pain, weight decrease, dizziness, abdominal pain, anorexia, diarrhea, dyspepsia, nausea, arthralgia, musculo-skeletal pain, myalgia, anxiety, concentration impaired, depression, insomnia, irritability, anaemia, coughing, dyspnea, pharyngitis, alopecia, pruritus, rash, dry skin.

No studies have been conducted with other medicdbinal products except for interferon alfa-2b and antacids. Inhibition of phosphorylation of zidovudine, stavudine. It is recommended that plasma HIV-RNA levels be closely monitored in patients concurrently treated with either of these two agents.