Rebetol
Rebetol Information
Genric Name: Ribavirin
Indications and Uses
Rebetol (ribavirin, USP) Capsules is indicated in combination with Introl A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.
Rebetol Ingredients and Composition
How Does Rebetol Work?
Mechanism of action
Ribavirin/Interferon alfa-2b, recombinant - The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy with Rebetol and Intron A has not been established.
How To Take Rebetol and Rebetol Dosage and Administration
Intron A Injection should be administered subcutaneously and Rebetol Capsules should be administered orally.
The recommended dose of Rebetol Capsules depends on the patient's body weight.
The recommended duration of Rebetol treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen. After 24 weeks of treatment virologic response should be assessed. Rebetol Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on Rebetol treatment for longer than 48 weeks in the previously untreated patient population.
In patients who relapse following interferon therapy, the recommended duration of Rebetol treatment is 24 weeks. There are no safety and efficacy data on Rebetol treatment for longer than 24 weeks in the relapse patient populations.
If you suspect a Rebetol Overdose
There is limited experience with Rebetol overdose.
Acute ingestion of up to 20 grams of Rebetol Capsules, Intron A ingestion of up to 120 million units, and subcutaneous doses of Intron A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse events related to the therapeutic use of Intron A and Rebetol. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of Intron A that exceed dosing recommendations.
There is no specific antidote for Intron A or Rebetol, and hemodialysis and peritoneal dialysis are not effective treatment of Rebetol overdose.
Rebetol Side Effects
Rebetol Precautions and Contraindications
Exacerbation of autoimmune disease has been reported in patients receiving alpha interferon therapy (including Intron A therapy). Rebetol/Intron A therapy should be used with caution in patients with other autoimmune disorders.
There have been reports of interferon, including Intron A (interferon alfa-2b, recombinant) exacerbating pre-existing psoriasis; therefore, combination Rebeton-Intron A therapy should be used in these patients only if the potential benefit justifies the potential risk.
The safety and efficacy of Rebetol/Intron A therapy has not been established in liver or other organ transplant patients, decompensated hepatitis C patients, patients who are nonresponders to interferon therapy, or patients coinfected with HBV or HIV.
The safety and efficacy of Rebetol Capsule monotherapy for the treatment of HIV infection, adenovirus, early RSV infection, parainfluenza, or influenza have not been established and Rebetol Capsules should not be used for these indications.
There is no information regarding the use of Rebetol Capsules with other interferons.
Contraindications to Rebetol
Combination Rebetol/Intron A therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking combination Rebetol/Intron A therapy. Combination Rebetol/Intron A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of rebetol Capsules. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
Rebetol Capsules in combination with INTRON A Injection is contraindicated in patients with a history of hypersensitivity to ribavirin and/or alpha interferon or any component of the capsule and/or injection.
Patients with autoimmune hepatitis must not be treated with combination Rebetol/Intron A therapy.
Taking Rebetol during Pregnancy or Breast-feeding
Combination Rebetol and Intron A therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during Rebetol therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination Rebetol and Intron A therapy. Women of childbearing potential and men must use two reliable forms of effective contraception during Rebetol treatment and during the 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species studied.
If pregnancy does occur during Rebetol treatment or during 6 months posttherapy, the patient must be advised of the significant teratogenic risk of REBETOL therapy to the fetus. Patients, or partners of patients, should immediately report any pregnancy that occurs during treatment or within 6 months after treatment cessation to their physician. Physicians are encouraged to report such cases by calling (800) 727-7064.
Storing Rebetol
Store the Rrebetol Capsules plus Introl A Injection combination package refrigerated between 2° and 8°C (36° and 46°F).
When separated, the individual bottle of Rebetol Capsules should be stored refrigerated between 2° and 8°C (36° and 46°F) or at 25° (77°F); excursions are permitted between 15° and 30°C (59° and 86°F).
When separated, the individuals vials of Intron A Injection and the Intron A multidose pen should be stored refrigerated between 2° and 8°C (36° and 46°F).
