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Pegintron and Rebetol

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PegIntron and Rebetol Combo Pack

Peglntron™/REBETOL® Combo Pack

Peglntron™ REDIPEN® Single-dose Delivery System
(peginterferon alfa-2b)

REBETOL®
(ribavirin, USP) Capsules

Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multipledose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, REBETOL® 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 therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking REBETOL® therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS - Pregnancy Category X and PATIENT INFORMATION.)

The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with REBETOL® therapy may result in a worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL®. (See WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION.)

Alpha interferons, including Peglntron™, may cause or aggravate fatal or lifethreatening 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 Peglntron™ therapy. (See WARNINGS, ADVERSE REACTIONS.)

DRUG DESCRIPTION

Peglntron™/REBETOL® Combo Pack contains Peglntron™ REDIPEN® Single-dose Delivery System (peginterferon alfa-2b) and REBETOL® (ribavirin) capsules.

Peglntron™

Peglntron™, peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant human alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the Peglntron™ molecule is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b is approximately 0.7 x 108 Ill/mg protein.

Interferon alfa-2b, is a water-soluble protein 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 gene from human leukocytes.

REDIPEN®

REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™ as a white to off-white tablet or powder that is whole or in pieces in the sterile active chamber and a second chamber containing Sterile Water for Injection, USP. Each Peglntron™ REDIPEN® contains either 67.5 meg, 108 meg, 162 meg, or 202.5 meg of Peglntron™, and 1.013 mg dibasic sodium phosphate anhydrous, 1.013 mg

monobasic sodium phosphate dihydrate, 54 mg sucrose and 0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration of up to 0.5 mL of solution. Following reconstitution, each REDIPEN® contains Peglntron™ at strengths of either 50 meg per 0.5 mL, 80 meg per 0.5 mL, 120 meg per 0.5 mL or 150 meg per 0.5 mL for a single use. Because a small volume of reconstituted solution is lost during preparation of Peglntron™, each REDIPEN® contains an excess amount of Peglntron™ powder and diluent to ensure delivery of the labeled dose.

REBETOL®

REBETOL® is Schering Corporation's brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3- carboxamide and has the following structural formula:

Ribavirin Structural Formula Illustration

Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The empirical formula is C8H12N405 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, sodium lauryl sulfate, silicon dioxide, 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.

Last reviewed on RxList: 6/24/2013
This monograph has been modified to include the generic and brand name in many instances.

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