Your healthcare provider may need to monitor your therapy more closely if you take INCIVEK with the following medicines. Talk to your healthcare provider if you are taking or starting to take medicines that contain:
alprazolam (Xanax® Pacerone®
), amlodipine (Norvasc®
atazanavir and ritonavir (Reyataz® bepridil hydrochloride (Vascor® bosentan (Tracleer® (Carbatrol®
, Equetro® Sandimmune®
clarithromycin (Biaxin® (Colcrys®
, Atripla® , Prevpac® , Dilacor XR® ), cyclosporine (Gengraf®
), amiodarone (Cordarone® ),
, Norvir®
), carbamazepine , Tegretol®
dexamethasone, digoxin (Lanoxin® (Cardizem® (Sustiva® Eryc®
, Ery-Tab® Stearate® , Erythrocin® ), felodipine (Plendil®
, Bepadin), ),
), colchicine , Neoral®
,
), desipramine (Norpramin® , Tiazac®
), erythromycin (E.E.S.® , Erythrocin
estradiol containing birth control methods (Lo LoestrinTM Lo®
), escitalopram (Lexapro® FE, Norinyl®
(TambocorTM
ketoconazole (Nizoral® (Dolophine® (Cardene®
nisoldipine (Sular® (Dilantin®
, MethadoseTM propafenone (Rythmol®
), itraconazole (Sporanox® ), methadone
), nifedipine (Adalat® , Phenytek®
), ), nicardipine , Procardia®
sildenafil for the treatment of erectile dysfunction (Viagra® tacrolimus (Prograf®
of erectile dysfunction (Cialis® telithromycin (Ketek® fumarate (Atripla® Viread®
), trazodone (Desyrel® OleptroTM
erectile dysfunction (Levitra® verapamil (Calan® Tarka®
(Coumadin® ), voriconazole (Vfend® , Covera-HS® , Complera® ),
), phenobarbital, phenytoin ), posaconazole (Noxafil® ), quinidine (Nuedexta®
), ), ),
), sirolimus (Rapamune® ), tadalafil for the treatment ),
), tenofovir disoproxil , Truvada® , Trialodine,
,
), vardenafil for the treatment of , Staxyn® , Isoptin®
), , ), warfarin ), zolpidem (Ambien® , Edluar® ).
Know the medicines you take. Keep a list of them with you and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take INCIVEK?
Take INCIVEK exactly as your healthcare provider tells you. Your healthcare provider will tell you how much INCIVEK to take and when to take it.
Take INCIVEK 3 times a day. Each dose should be taken 7 to 9 hours apart. Eat a meal or snack that contains about 20 grams of fat, within 30 minutes before you take each dose of INCIVEK. Talk to your healthcare provider about examples of foods that you can eat that contain about 20 grams of fat. Always take INCIVEK with food.
If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible.
), ), diltiazem
), efavirenz ,
), ethinyl
, Ortho Tri-Cyclen ), flecainide
), ,
If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose at your normal dosing schedule.
Do not stop taking INCIVEK unless your healthcare provider tells you to. If you think there is a reason to stop taking INCIVEK, talk to your healthcare provider before doing so.
If your healthcare provider tells you to stop taking INCIVEK, you should not start taking it again even if the reason for stopping goes away.
If you take too much INCIVEK or overdose, call your healthcare provider or local Poison Control Center, or go to the nearest hospital emergency room right away.
What are the possible side 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.
© 2012 Vertex Pharmaceuticals Incorporated | VX12-3818 | 06/12 INCIVEK and the Blue Arrow logo are trademarks of Vertex Pharmaceuticals Incorporated. Other trademarks used herein are the properties of their respective owners.
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
Revised March 2012 ©2012 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.
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