MEDICATION GUIDE INCIVEK (in-SEE-veck) (telaprevir) Film-Coated Tablets
Read this Medication Guide before you start taking INCIVEKTM
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 peginterferon alfa and ribavirin and for 6 months after treatment is over.
If you are a female who can become pregnant, or you are a female whose male partner takes these medicines:
You must have a negative pregnancy test before starting treatment, each month during treatment, and for 6 months after your treatment ends.
You must use 2 forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control including birth control pills, vaginal rings, implants, or injections may not work during treatment with INCIVEK. You could become pregnant. Talk to your healthcare provider about other forms of birth control that may be used during this time. If your healthcare provider tells you to stop taking INCIVEK, peginterferon alfa and ribavirin, you must still use two forms of birth control for the 6 months after treatment with these medicines. You may use a hormonal form of birth control as one of your two forms of birth control after 2 weeks of stopping INCIVEK.
If you or your female sexual partner becomes pregnant while taking INCIVEK, peginterferon alfa, and ribavirin or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
2. Skin reactions. Mild skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become severe and require treatment in a hospital.
Call your healthcare provider right away if you develop any skin changes with any of the symptoms below. Your healthcare provider will decide if your skin changes or symptoms may be a sign of a serious skin reaction:
rash, with or without itching blisters or skin lesions mouth sores or ulcers red or inflamed eyes, like “pink eye” (conjunctivitis)
swelling of your face fever
Your healthcare provider will decide if you need treatment for your rash or if you need to stop taking INCIVEK, or any of your other medicines.
Never stop taking INCIVEK combination treatment without talking with your healthcare provider first.
See “What are the possible side effects of INCIVEK?” for more information about side effects.
3. Do not take INCIVEK alone to treat chronic hepatitis C infection. INCIVEK must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
What is INCIVEK?
INCIVEK is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
Who should not take INCIVEK?
Do not take INCIVEK if you: are pregnant or may become pregnant. See “What is the most important information I should know about INCIVEK?”
are a man with a sexual partner who is pregnant.
take certain medicines. INCIVEK may cause serious side effects when taken with certain medicines. Read the section “What should I tell my healthcare provider before taking INCIVEK?”
Talk to your health care provider before taking INCIVEK if any of the above applies to you.
What should I tell my healthcare provider before taking INCIVEK?
Before you take INCIVEK, tell your healthcare provider if you:
have certain blood problems, such as low red blood cell count (anemia)
have liver problems other than hepatitis C infection
have hepatitis B infection have Human Immunodeficiency Virus (HIV)
infection or any other problems with your immune system
history of gout or high uric acid levels in your blood
have had an organ transplant plan to have surgery have any other medical condition are breastfeeding. It is not known if INCIVEK
passes into your breast milk. You and your healthcare provider should decide if you will take INCIVEK or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
INCIVEK and other medicines can affect each other. This can cause you to have too much or not enough INCIVEK or your other medicines in your body, and cause side effects that can be serious or life-threatening. Your healthcare provider may need to change the amount of medicine you take.
Do not take INCIVEK if you take a medicine that contains:
alfuzosin hydrochloride (Uroxatral® cisapride (Propulsid®
)
ergot, including: dihydroergotamine mesylate (D.H.E 45®
ergotamine tartrate (Cafergot® Ergomar® Wigraine®
, Migranal® , Ergostat®
, Wigrettes)
methylergonovine maleate (Ergotrate®
lovastatin (Advicor® pimozide (Orap® rifampin (Rifadin®
, Methergine® )
sildenafil citrate (Revatio® (Adcirca®
artery hypertension (PAH) simvastatin (Zocor®
) ) , Altoprev® , Rifamate®
, Mevacor® , Rifater®
) ) or tadalafil
) for the lung problem, pulmonary , Vytorin®
, Simcor® )
St. John’s wort (Hypericum perforatum) or products containing St. John’s wort triazolam (Halcion®
Tell your healthcare provider if you are taking or starting to take medicines that contain:
atorvastatin (Lipitor® (Pulmicort® (Colcrys®
ritonavir (Norvir® Flonase®
, Caduet® , Rhinocort®
fosamprenavir (Lexiva® (Norvir®
, Serevent® ). ), budesonide
), darunavir (Prezista® , Flovent®
methylprednisolone (Medrol® rifabutin (Mycobutin® (Advair®
, Symbicort® ) and
),
), fluticasone (Advair® , Veramyst®
) and ritonavir
), lopinavir and ritonavir (Kaletra® ), prednisone,
), ), salmeterol
), colchicine ,
) ) , Migergot® , , Medihaler Ergotamine, )
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