Manufacturer: Schering Corporation

Formulation/Price (AWP): $240 to $278 per week. 50 mcg/0.5 mL @ $240; 80 mcg/0.5 mL @ $253; 120 mcg/0.5 mL @ $265; 150 mcg/0.5 mL @ $279.

FDA Indication: PEG-interferon b monotherapy is indicated for the treatment of compensated chronic hepatitis C not previously treated with interferon alpha.

Pharmacology and Pharmacokinetics:

• Absorption: Approximately 20 hours after a subcutaneous injection
  
• C_max: 554 pg/mL after peginterferon 1mcg/kg SQ. C_max occurs between 15 to 44 hours post-dose and is sustained for up to 48 to 72 hours.
  
• C_min: 94 pg/mL at week 4 and 320 pg/mL at week 48.
  
• Volume of distribution: Approximately 1 L/kg (similar to non-pegylated interferon). PEG-interferon has approximately 10-fold greater C_max and 50-fold greater AUC compared to non-pegylated interferon 2b.
  
• Half-life: 40 hours (range 22 to 60 hours), 5-fold greater mean half-life due to decreased clearance compared to non-pegylated interferon.
  
• Renal elimination: Approximately 30%
  
• Dose reduction to 0.5 mcg/kg recommended for absolute neutrophil count (ANC) <750/mL or platelet count <80,000/mL.
  

Usual Dose: 1 mcg/kg q week

• Weight based dosage recommendation:

Dosage in Renal Failure: Consider reducing dose to 0.5 mcg/kg in patients with creatinine clearance less than 50 mL/min (Recommendation based on pharmacokinetic studies with limited clinical data).

Drug Interactions: None known.

Side Effects:

• Common: Flu-like symptoms, headache, dizziness, fatigue, fever, rigor, injection site inflammation, depression (29%), insomnia, alopecia, GI (abdominal pain, anorexia, nausea/vomiting/diarrhea).
  
• Occasional: Thrombocytopenia, neutropenia, hypo and hyperthyroidism, elevation of liver enzyme 2- to 5-fold above baseline.
  
• Rare: Hallucination, hyperglycemia, cardiovascular events, ulcerative and hemorrhagic colitis, pancreatitis, pneumonitis, retinal hemorrhage, cotton wool spots and hypersensitivity reaction.
  

Pregnancy Risk: Category C. Abortifacient in rhesus monkeys. No human data. Recommend that patients use an effective form of contraception during treatment with interferon. Breastfeeding: No data.

20020901
JH20020907

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