Product
PegIntron/REBETOL
Approval Date
December 11, 2008
Release Date
Currently available
Company
Schering-Plough
Class
PegIntron: interferon alpha
REBETOL: nucleoside analogue
Indication
A combination therapy for use in previously untreated patients3 years of age and older with chronic hepatitis C.
Active Ingredient
PegIntron: Peginterferon alfa-2b
REBETOL: Ribavirin
Agency Roster
PegIntron: Agency Rx LLC
REBETOL: Project Basis Only
Marketing Strategy/Execution
This represents the first and only approved peginterferon incombination with ribavirin for treating pediatric hepatitis C. It is estimatedthat approximately 130,000 children in the United States are infected with thehepatitis C virus (HCV). The most common mode of HCV infection for pediatricpatients today is maternal-infant transmission.
Also in the Pipeline(courtesy of Adis R&D Insight)
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Drug: Talpha 1
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Active Ingredient: Thymalfasin
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Source: Wolters Kluwer Health
Adverse Reactions
Flu-like symptoms (fever, headache, myalgia, fatigue); hepatic, hematologic, respiratory, skin, genitourinary system, CNS, cardiovascular, endocrine (esp thyroid), GI, or visual disorders; hemorrhagic colitis, hypertriglyceridemia, pancreatitis, antibody formation, infections, injection site reactions; Others (see literature). Children: weight loss, growth inhibition.
Adults
Give SC once weekly (same day each week ). ≥18yrs: Monotherapy: initially 1microgram/kg per week. Treat for 1 year; consider discontinuing if inadequate response after 6 months. Combination with ribavirin: 1.5mcg/kg per week. Genotype 1: treat for 48 weeks. Genotype 2/3: treat for 24 weeks. Reduce dose if serious adverse reaction develops; discontinue if persists. Neutropenia, thrombocytopenia, depression: see literature. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%.
Children
<3yrs: not recommended. Give by SC inj. Combination w. ribavirin: ≥3yrs: 60mcg/m2/week. Discontinue therapy at 12 weeks if treatment week 12 HCV-RNA drops <2 log10 compared to pretreatment or at 24 weeks if HCV-RNA are detectable. Reduce dose if serious adverse reaction develops; discontinue if persists. Neutropenia, thrombocytopenia, depression: see literature. Renal impairment: CrCl 30–50mL/min: reduce dose by 25%; CrCl 10–29mL/min, hemodialysis: reduce dose by 50%.
Contraindications
Hepatic decompensation before or during treatment. Autoimmune hepatitis.
Precautions
May cause or exacerbate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Severe psychiatric disorders (esp. depression). Cardiovascular or pulmonary disease. Severe myelosuppression, colitis, pancreatitis: discontinue if occurs. Uncontrolled thyroid abnormalities. Diabetes. Coagulation disorders. Maintain adequate hydration. Monitor blood, thyroid, visual and liver function before and during therapy; EKG in cardiovascular disease. Psoriasis. Renal dysfunction (CrCl <50mL/min). Transplant recipients. Hepatitis C virus with HIV or HBV coinfection. Elderly. Debilitated. Pregnancy (Cat.C); use adequate contraception. Nursing mothers: not recommended.
Interactions
Caution with myelosuppressives, and drugs that can exacerbate depression. May potentiate theophylline (may double its levels), methadone (monitor). Caution with drugs metabolized by CYP2C8/9 (eg, warfarin, phenytoin), or CYP2D6 (eg, flecainide).