Telaprevir Dosage

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Usual Adult Dose for:

Additional dosage information:

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:
-HCV-RNA levels should be monitored at weeks 4 and 12 to determine combination therapy duration and assess for treatment futility.

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

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Must use in combination with peginterferon alfa and ribavirin.
-Always take each dose within 30 minutes after eating food containing about 20 g of fat.
-Swallow tablets whole; do not chew, crush, break, cut, or dissolve tablets before swallowing.
-Adequate fluid intake during therapy is important.
-The manufacturer's product information should be consulted regarding missed doses.

General:
-The prescribing information for peginterferon alfa and ribavirin should be consulted for additional information.

Monitoring:
-Endocrine: Chemistry evaluations, including TSH (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
-General: HCV-RNA levels (at weeks 4 and 12 and as clinically indicated); monthly pregnancy tests (immediately prior to, during, and for 6 months after stopping ribavirin therapy)
-Hematologic: Hematology evaluations, including hemoglobin, white cell differential, and platelet count (prior to and at weeks 2, 4, 8, and 12 and as clinically appropriate; earlier and more frequent monitoring of hemoglobin for some patients)
-Hepatic: Chemistry evaluations, including hepatic enzymes and bilirubin (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
-Metabolic: Chemistry evaluations, including electrolytes and uric acid (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
-Renal: Chemistry evaluations, including serum creatinine (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)

Patient advice:
-Hydration and fluid intake during telaprevir combination therapy are important; learn to recognize signs and symptoms of dehydration (e.g., thirst, dry mouth, decreased urine output, more concentrated urine); contact healthcare provider if oral fluid intake is poor or if severe vomiting and/or diarrhea occur.

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