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ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HCV infections
telaprevir
J05AP02
Forms & Strengths
- Film-coated tablets: 375 mg
Adult Dosing
- 750 mg orally every 8 hours (with food, not low-fat) for 12 weeks in combination with peginterferon alfa and ribavirin
- Must be followed by 12 or 36 additional weeks of peginterferon alfa and ribavirin dual therapy depending on prior response
Pediatric Dosing
- Safety and efficacy have not been established in pediatric patients below 18 years of age
Indications
- Chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin in treatment-naive or previously treated patients with compensated liver disease
Mechanism of Action
- Hepatitis C virus (HCV) NS3/4A serine protease inhibitor that blocks viral replication
Contraindications
- Co-administration with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events
- Co-administration with potent CYP3A inducers significantly reducing telaprevir plasma concentrations
- Known hypersensitivity to telaprevir or any of its components
- Pregnancy (due to co-administration with ribavirin)
Adverse Reactions
- Rash (including serious skin reactions such as Stevens-Johnson syndrome and DRESS)
- Pruritus
- Anemia
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Anal pruritus and hemorrhoids
Drug Interactions
- Potent CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) decrease telaprevir levels
- CYP3A inhibitors may increase telaprevir levels
- Telaprevir is a potent inhibitor and substrate of CYP3A and P-glycoprotein, altering pharmacokinetics of co-administered drugs like statins, antiarrhythmics, and certain immunosuppressants
Curated Content: Needs Vetting Before Put to Clinical Use