instructed by their healthcare provider.
17.3 Hepatitis 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.
17.4 Administration
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 Incorporated. VERTEX and the VERTEX triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated.
The brands listed are the registered trademarks of their respective owners and are not trademarks of Vertex Pharmaceuticals Incorporated.
MEDICATION GUIDE
INCIVEK (in-SEE-veck)
(telaprevir)
Film-Coated Tablets
Read this Medication Guide before you start taking INCIVEK™ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
INCIVEK is taken along with peginterferon alfa and ribavirin. You should also read those Medication Guides.
What is the most important information I should know about INCIVEK?
INCIVEK combination treatment may cause serious side effects including:
1.
Birth defects or death of your unborn baby. INCIVEK in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking INCIVEK with peginterfe |
