"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
REBETRON™ (rebetol and intron a combination therapy)
Combination Therapy containing
REBETOL® (ribavirin, USP) Capsules and INTRON® A (interferon alfa-2b, recombinant) Injection
CONTRAINDICATIONS AND WARNINGS
Combination REBETOL/INTRON A therapy is contraindicated in females who are pregnant and in the male partners of females who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination REBETOL/INTRON A therapy. Females of childbearing potential and males must use two reliable forms of effective contraception during 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. See CONTRAINDICATIONS and WARNINGS. REBETOL monotherapy is not effective for the treatment of chronic hepatitis C and should not be used for this indication. See WARNINGS.
Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. See WARNINGS, and ADVERSE REACTIONS.
REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:
Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The empirical formula is C8H12N4O5 and the molecular weight is 244.21.
REBETOL Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
INTRON A is Schering Corporation's brand name for interferon alfa-2b, recombinant, a purified, sterile, recombinant interferon product.
Interferon alfa-2b, recombinant has been classified as an alpha interferon and is a water-soluble protein composed of 165 amino acids with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. The fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride at a concentration of 5 to 10 mg/L; the presence of this antibiotic is not detectable in the final product.
INTRON A Injection is a clear, colorless solution. The 3 million IU vial of INTRON A Injection contains 3 million IU of interferon alfa-2b, recombinant per 0.5 mL. The 18 million IU multidose vial of INTRON A Injection contains a total of 22.8 million IU of interferon alfa-2b, recombinant per 3.8 mL (3 million IU/0.5 mL) in order to provide the delivery of six 0.5 mL doses, each containing 3 million IU of INTRON A (for a label strength of 18 million IU). The 18 million IU INTRON A Injection multidose pen contains a total of 22.5 million IU of interferon alfa-2b, recombinant per 1.5 mL (3 million IU/0.2 mL) in order to provide the delivery of six 0.2-mL doses, each containing 3 million IU of INTRON A (for a label strength of 18 million IU). Each mL also contains 7.5 mg sodium chloride, 1.8 mg sodium phosphate dibasic, 1.3 mg sodium phosphate monobasic, 0.1 mg edetate disodium, 0.1 mg polysorbate 80, and 1.5 mg m-cresol as a preservative.
Based on the specific activity of approximately 2.6 x 108 IU/mg protein as measured by HPLC assay, the corresponding quantities of interferon alfa-2b, recombinant in the vials and pen described above are approximately 0.012 mg, 0.088 mg, and 0.087 mg protein, respectively.
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.
What are the possible side effects of interferon alfa-2b and ribavirin (Rebetron)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- pale or yellowed skin, dark colored urine;
- fever, chills, body aches, flu symptoms, easy bruising or bleeding, unusual weakness;
- confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;
- vision problems;
- high fever with...
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Rebetron Information
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