hods) prior to initiating treatment. Patients (both male and female) should be advised to notify their health care provider immediately in the event of a pregnancy [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].
Patients should also be advised that hormonal contraceptives may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see Drug Interactions (7)]. During this time, female patients of childbearing potential should use 2 non-hormonal methods of effective birth control. Examples of non-hormonal methods of contraception include a male condom with spermicidal jelly OR female condom with spermicidal jelly (a combination of a male condom and a female condom is not suitable), a diaphragm with spermicidal jelly, a cervical cap with spermicidal jelly, or an intrauterine device (IUD).
17.2Serious Skin Reactions/Rash
Patients should be informed that INCIVEK combination treatment may cause rash. The rash can be severe and may be accompanied by fever and skin breakdown. Patients should promptly report any skin changes or itching to their healthcare provider. Patients should not stop INCIVEK due to rash unless instructed by their healthcare provider.
17.3Hepatitis C Virus Transmission
Patients should be informed that the effect of treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of the hepatitis C virus during treatment or in the event of treatment failure should be taken.
17.4Administration
Patients should be advised INCIVEK must be administered in combination with both peginterferon alfa and ribavirin. If peginterferon alfa and/or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.
Patients should be advised that the dose of INCIVEK must not be reduced or interrupted, as it may increase the possibility of treatment failure.
The recommended dose of INCIVEK tablets is 750 mg (two 375-mg tablets) taken orally 3 times a day (7-9 hours apart) with food containing approximately 20 grams of fat. Patients should be advised that the fat content of the meal or snack is critical for the absorption of telaprevir. Food that is taken with INCIVEK should be ingested within 30 minutes prior to each INCIVEK dose. Examples of some foods that could be taken with INCIVEK include: a bagel with cream cheese, ½ cup nuts, 3 tablespoons peanut butter, 1 cup ice cream, 2 ounces American or cheddar cheese, 2 ounces potato chips, or ½ cup trail mix.
Patients should be informed about what to do in the event they miss a dose of INCIVEK:
In case a dose of INCIVEK is missed within 4 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVEK with food as soon as possible.
If more than 4 hours has passed since INCIVEK is usually taken, the missed dose should NOT be taken and the patient should resume the usual dosing schedule.
Patients should be advised to contact their health care provider if they have questions.
Patients should be advised that they can contact the local Poison Control Center in the event of an overdose.
VERTEX™
Manufactured for
Vertex Pharmaceuticals Incorporated
Cambridge, MA 02139
U.S. Patent No. 7,820,671
©2011 Vertex Pharmaceuticals Incorporated
All rights reserved.
INCIVEK and the Blue Arrow logo are trademarks of Vertex Pharmaceuticals Inc
