Adult Dosing
Genotype 1 chronic hepatitis C
- Recommended dose: 1,125 mg (3 tabs) PO bid
- Administer with peginterferon alfa and ribavirin x12 wks
Notes:- Monitor HCV-RNA levels at 4 and 12 wks to determine combination treatment duration and assess for treatment futility
- Do not reduce or interrupt telaprevir dose in order to prevent treatment failure
- Discontinue treatment in patients with HCV-RNA levels
1000 IU/mL at treatment wk 4 or 12; or in case of confirmed detectable HCV-RNA levels at wk 24 - If peginterferon alfa or ribavirin is discontinued for any reason, then telaprevir should also be discontinued
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Ribavirin may cause birth defects and/or death of the exposed fetus. Hence, pregnancy should be avoided in female patients and in female partners of male patients. Prior to initiating therapy, patients must have a negative pregnancy test. Use 2 effective methods of contraception during treatment and for 6 months after stopping treatment; also, perform monthly pregnancy tests during this time
- Therapy may cause serious skin reactions, including drug rash with eosinophilia and systemic symptoms and Stevens-Johnson syndrome. Immediately suspend combination therapy if such serious skin reactions occur
- Rashes developed in a majority of patients receiving combination treatment. Patients with mild to moderate rashes should be monitored for progression of rash or development of systemic symptoms. Discontinue telaprevir if the rash becomes severe or if systemic symptoms develop. Peginterferon alfa and ribavarin may be continued; if the rashes do not show any improvement following discontinuation of telaprevir, consider sequential or simultaneous interruption or discontinuation of peginterferon alfa and ribavarin
- Anemia may occur with peginterferon alfa and ribavirin therapy. Hemoglobin levels should be measured prior to and at regular intervals during telaprevir combination therapy. For decreased hemoglobin levels, consider dose reductions of ribavirin; if anemia persists in spite of ribavirin reductions, telaprevir discontinuation should be considered. If ribavirin is permanently discontinued, telaprevir should also be discontinued permanently. Telaprevir dose should not be reduced and should not be re-administered after discontinuation
- Monitor HCV-RNA levels at weeks 4 and 12 to determine treatment duration. Consider hematology and chemistry evaluations prior to and at Weeks 2, 4, 8, and 12 and as clinically indicated
Cautions: Use cautiously in
- Hepatic impairment (Child-Pugh class B or C)
- HIV co-infection
- HBV co-infection
- Solid organ transplant
- Geriatric patients
Supplemental Patient Information
- Inform patients that the effect of treatment of hepatitis C infection on transmission is not known, and that extreme care to prevent transmission of the hepatitis C virus during treatment or in the event of treatment failure should be taken
Pregnancy Category:X (telaprevir/peginterferon alfa/ribavirin combination); B (telaprevir monotherapy)
Breastfeeding: Safety unknown. According to manufacturer's data, because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to treatment initiation.
