e effects of INCIVEK?
INCIVEK may cause serious side effects including:
•See "What is the most important information I should know about INCIVEK?"
•Low red blood cell count (anemia), which can be severe. Tell your healthcare provider if you have any of these symptoms of anemia:
•dizziness
•shortness of breath
•tiredness
•weakness
Your healthcare provider will do blood tests regularly to check your red blood cell count during treatment. If your anemia is severe, your healthcare provider may tell you to stop taking INCIVEK. If INCIVEK is stopped for this reason, do not start taking it again.
Common side effects of INCIVEK in combination with peginterferon alfa and ribavirin include:
•itching
•nausea
•diarrhea
•vomiting
•anal or rectal problems, including:
◦hemorrhoids
◦discomfort or burning around or near the anus
◦itching around or near the anus
•taste changes
•tiredness
Tell your healthcare provider about any side effect that bothers you or does not go away.
These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Vertex Pharmaceuticals Incorporated at 1-877-824-4281.
How should I store INCIVEK?
•Store INCIVEK tablets at room temperature between 59ºF to 86ºF (15°C to 30°C).
Keep INCIVEK and all medicines out of the reach of children.
General information about INCIVEK
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 Incorpor |
