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)

Drug: ABF 656
Manufacturer: Human Genome Sciences/ Novartis
Indication: Hepatitis C

Active Ingredient: Albinterferon alfa-2b
Phase: III

 

Drug: SCH 503034
Manufacturer: Schering-Plough
Indication: Hepatitis C

Active Ingredient: Boceprevir
Phase: III

 

Drug: AdvaferonÂ
Manufacturer: Amgen/ Three Rivers Pharmaceuticals
Indication: Hepatitis C

Active Ingredient: Interferon alfacon-1
Phase: Launched

 

Drug: LY 570310
Manufacturer: Eli Lilly/ Janssen Pharmaceuticals
Indication: Hepatitis C (Combination therapy, Treatment-experienced patients: REALIZEtrial)

Active Ingredient: Telaprevir
Phase: III

 

Drug: Talpha 1
Manufacturer: University of Texas at Austin/Elvetium
Indication: Hepatitis B

Active Ingredient: Thymalfasin
Phase: Launched
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).