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Telaprevir Dosage

Applies to the following strengths: 375 mg

Usual Adult Dose for Chronic Hepatitis C

1125 mg orally twice a day (10 to 14 hours apart) with food (not low fat)

Duration of therapy: 12 weeks in combination with peginterferon alfa and ribavirin

Comments:


Approved indication: In combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in patients with compensated liver disease (including cirrhosis) who are therapy-naive or who have previously used interferon-based therapy, including prior null responders, partial responders, and relapsers

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.
End-stage renal disease: Data not available

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A, score 5 to 6): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C, score 7 or greater) or decompensated liver disease: Not recommended.

Dose Adjustments

To prevent treatment failure, telaprevir dosage must not be reduced or interrupted. The prescribing information for peginterferon alfa and/or ribavirin should be consulted for appropriate dose adjustments. If peginterferon alfa or ribavirin is stopped for any reason, telaprevir must also be discontinued.

Recommended therapy duration in therapy-naive and prior relapse patients:
HCV-RNA undetectable at weeks 4 and 12:
Triple therapy (telaprevir, peginterferon alfa, and ribavirin): First 12 weeks
Dual therapy (peginterferon alfa and ribavirin): Additional 12 weeks
Total therapy duration: 24 weeks

HCV-RNA detectable (1000 international units/mL or less) at weeks 4 and/or 12:
Triple therapy: First 12 weeks
Dual therapy: Additional 36 weeks
Total therapy duration: 48 weeks

Recommended therapy duration in prior partial and null responder patients:
Triple therapy: First 12 weeks
Dual therapy: Additional 36 weeks
Total therapy duration: 48 weeks

Therapy discontinuation is recommended in all patients if HCV-RNA levels are greater than 1000 international units/mL at 4 or 12 weeks of therapy (telaprevir therapy complete at 12 weeks), or if HCV-RNA levels remain detectable at 24 weeks of therapy.

Precautions

US BOXED WARNING:


Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:


General:

Monitoring:

Patient advice:

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.