It is not known if treatment with INCIVEK will prevent you from infecting another person with the hepatitis C virus during treatment or if you do not respond to treatment.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use INCIVEK for a condition for which it was not prescribed. Do not give INCIVEK to other people, even if they have the same symptoms or condition you have. It may harm them.

This Medication Guide summarizes the most important information about INCIVEK. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about INCIVEK that is written for healthcare professionals.

For more information, go to www.incivek.com or call 1-877-824-4281.

What are the ingredients in INCIVEK?

Active ingredient: telaprevir

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 40, dibasic calcium phosphate (anhydrous), FD&C Blue No. 2, hypromellose acetate succinate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for
Vertex Pharmaceuticals Incorporated
Cambridge, MA 02139

Issued May 2011

©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 trademarks of their respective owners. They are not trademarks of Vertex Pharmaceuticals Incorporated. The makers of these brands are not affiliated with and do not endorse Vertex Pharmaceuticals Incorporated or its products.

PRINCIPAL DISPLAY PANEL - 375 mg Tablet Carton

168 TABLETS
NDC 51167-100-01

INCIVEK™
(telaprevir)
Tablets
375 mg

Rx only

ATTENTION PHARMACIST: Dispense the enclosed Medication Guide to each patient.

INCIVEK
telaprevir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-100
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
telaprevir (telaprevir)  telaprevir 375mg
 
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
SODIUM STEARYL FUMARATE 
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) 
SODIUM LAURYL SULFATE 
POLYVINYL ALCOHOL 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 3350 
TALC 
FD&C Blue No. 2 
FD&C Red No. 40 
 
Product Characteristics
Color PURPLE Score no score 
Shape OVAL Size 20mm
Flavor  Imprint Code V;375 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-100-01 4 BOX ( BOX) in 1 CARTON contains a BOX
1  7 BLISTER PACK ( BLISTER PACK) in 1 BOX This package is contained within the CARTON(51167-100-01) andcont