FULL PRESCRIBING INFORMATION
WARNING: SERIOUS SKIN REACTIONS
Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVO-(INCIVEK) combination treatment [see Warnings and Precautions (5.1)]. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO-(INCIVEK) combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVO-(INCIVEK), peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.
1 INDICATIONS AND USAGE
1.1 Chronic Hepatitis C
INCIVO-(INCIVEK)™ (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers [seeClinical Studies (14.2 and14.3), including definitions of these terms].
The following points should be considered when initiating treatment with INCIVO-(INCIVEK):
INCIVO-(INCIVEK)must notbe administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin [seeWarnings and Precautions (5.6)].
A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVO-(INCIVEK) combination treatment [seeMicrobiology (12.4) andClinical Studies (14.3)].
INCIVO-(INCIVEK) efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVO-(INCIVEK) or other HCV NS3/4A protease inhibitors [seeMicrobiology (12.4)].
The recommended dose of INCIVO-(INCIVEK) tablets is 750 mg (two 375-mg tablets) taken orally 3 times a day (7-9 hours apart) with food (not low fat) [seeClinical Pharmacology (12.3) andPatient Counseling Information (17.4)].
For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information.
Duration of Treatment
The recommended duration of treatment with INCIVO-(INCIVEK) is 12 weeks in combination with peginterferon alfa and ribavirin. HCV RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).
In clinical trials, HCV RNA in plasma was measured using a COBAS®TaqMan®assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. SeeLaboratory Tests (5.5)for a description of HCV RNA assay recommendations.
Treatment-Naïve and Prior Relapse Patients
HCV RNA*
Triple Therapy
Dual Therapy
Total Treatment Duration
INCIVO-(INCIVEK), peginterferon alfa and ribavirin
peginterferon alfa and ribavirin
Undetectable (Target Not Detected) at Weeks 4 and 12
First 12 weeks
Additional 12 weeks
24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12
