HIGHLIGHTS OF PRESCRIBING INFORMATION
Indications And Usage
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers. (1)
•INCIVEK must not be used as monotherapy and must only be used in combination with peginterferon alfa and ribavirin. (5.7)
•A high proportion of previous null responders (particularly those with cirrhosis) did not achieve Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK. (12.4, 14.3)
•INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors. (12.4)
Dosage And Administration
•750 mg taken 3 times a day (7-9 hours apart) with food (not low fat). (2, 12.3, 17.4)
•INCIVEK must be administered with both peginterferon alfa and ribavirin for all patients for 12 weeks, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response and prior response status. (2)
•For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information. (2)
Dosage And Administration 2
•375 mg tablets (3)
Contraindications
•All contraindications to peginterferon alfa and ribavirin also apply since INCIVEK must be administered with peginterferon alfa and ribavirin. (4)
•Pregnant women and men whose female partners are pregnant: Because ribavirin may cause birth defects and fetal death, telaprevir in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4, 5.1, 8.1, 17.1)
•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. (4)
•strongly induce CYP3A which may lead to lower exposure and loss of efficacy of INCIVEK. (4)
Warnings And Precautions
•Pregnancy: Use with Ribavirin and Peginterferon alfa: Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception, and undergo monthly pregnancy tests. (5.1, 8.1)
•Serious Skin Reactions: Serious skin reactions including Drug Rash with Eosinophilia and Systemic Symptoms and Stevens-Johnson Syndrome have been reported. For serious skin reactions, all components of INCIVEK combination treatment should be discontinued immediately. (5.2)
•Rash: Patients with mild to moderate rash should be monitored for progression. If rash progresses and becomes severe, INCIVEK should be discontinued. (5.3)
•Anemia: Monitor hemoglobin prior to and at regular intervals during INCIVEK combination treatment. Follow dose modifications for ribavirin; discontinue INCIVEK if required. (5.4)
