INCIVEK combination treatment may cause serious side effects, including:

Skin rash and serious skin reactions. Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death.

Call your healthcare provider right away if you develop any skin changes or itching during treatment with INCIVEK. Your healthcare provider will decide if your skin changes or any of the following symptoms may be a sign of a serious skin reaction: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, mouth sores or ulcers, or red or inflamed eyes, like "pink eye" (conjunctivitis). Your healthcare provider will decide if you need treatment for your skin 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.

Please see additional Important Safety Information.

For adults with chronic hepatitis C genotype 1 infection with stable liver problems

  • INCIVEK Triple Therapy is a combination of 3 medicines used to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems: INCIVEK + peginterferon alfa + ribavirin.

INCIVEK is:

  • Pronounced in-SEE-veck, INCIVEK is used to treat chronic
    (lasting a long time) hepatitis C genotype 1 infection
  • For adults with stable liver problems, who have not been treated before or who have failed previous treatment
  • A prescription medicine used with the medicines pegylated interferon alfa (peginterferon alfa) and ribavirin

It is not known if INCIVEK is safe and effective in children under 18 years of age.

INCIVEK Triple Therapy is a combination of 3 medicines used to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems: INCIVEK + peginterferon alfa + ribavirin.

INCIVEK directly targets the hepatitis C virus.

Do not take INCIVEK alone to treat chronic hepatitis C. INCIVEK must be used with peginterferon alfa and ribavirin. If you stop taking INCIVEK, you can’t restart. Be sure to take your medicine the way your healthcare provider recommends.

You only take INCIVEK for the first 12 weeks of treatment. An additional 12 or 36 weeks of peginterferon alfa and ribavirin alone is required.

Remember, INCIVEK is part of a combination treatment and can never be taken alone. Never stop taking INCIVEK Triple Therapy without checking with your healthcare provider first.

Your blood tests at weeks 4 and 12 are important. They help show how INCIVEK Triple Therapy is working for you. Based on those results, your healthcare provider will:

  • Determine how much longer your treatment will be
  • Stop your treatment if it is not working

You will have other blood tests throughout your treatment. If your body is not responding to treatment at any point, your healthcare provider may stop your treatment.

*INCIVEK Triple Therapy is a combination of 3 medicines used to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems: INCIVEK + peginterferon alfa + ribavirin.

It is important to take INCIVEK the right way, as part of your prescribed triple therapy with peginterferon alfa and ribavirin. Peginterferon alfa is a prescription injection you take 1 time a week. Ribavirin is a prescription pill that you take 2 times a day, or as often as your healthcare provider prescribes.

Take INCIVEK as prescribed:

  • Eat food that has some fat in it (about 20 grams) within 30 minutes before taking each dose
  • INCIVEK must be taken with peginterferon alfa and ribavirin
  • 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.
  • INCIVEK does not need to be refrigerated. Store INCIVEK pills at room temperature between 68°F to 77°F (20°C to 25°C).

What is INCIVEK?

INCIVEK® (telaprevir) 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.

IMPORTANT SAFETY INFORMATION

Serious Side Effects

INCIVEK combination treatment may cause serious side effects, including:
  • Skin rash and serious skin reactions. Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death.

    Call your healthcare provider right away if you develop any skin changes or itching during treatment with INCIVEK. Your healthcare provider will decide if your skin changes or any of the following symptoms may be a sign of a serious skin reaction: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, mouth sores or ulcers, or red or inflamed eyes, like "pink eye" (conjunctivitis). Your healthcare provider will decide if you need treatment for your skin 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.
  • Low red blood cell count (anemia) that can be severe. Tell your healthcare provider if you have any of these symptoms of anemia: dizziness, shortness of breath, tiredness, or 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 this happens, do not start taking it again.
  • Birth defects or death of an unborn baby. INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plan to become pregnant, do not take these medicines. You or your 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 if you are a female whose male partner takes these medicines:
    • You must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after your treatment ends.
    • You must use 2 effective methods of birth control during treatment and for 6 months after all treatment has ended. These 2 forms of birth control should not contain hormones, as these may not work during treatment with INCIVEK. Talk to your healthcare provider about the forms of birth control you should use during this time.

      Two weeks after stopping INCIVEK, you can use a hormonal form of birth control as one of your two forms of birth control.
    • If you or your partner becomes pregnant during treatment or within 6 months after stopping these medicines, tell your healthcare provider right away. Contact the Ribavirin Pregnancy Registry right away by calling 1-800-593-2214. The Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while pregnant.

Who should not take INCIVEK?

  • Do not take INCIVEK if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
  • Do not take INCIVEK if you are taking certain medicines as there could be serious side effects. If these drugs are taken together, this can cause you to have too much or not enough INCIVEK or your other medicines in your body. It can also cause side effects that can be serious or life-threatening.
    • These medicines include: alfuzosin hydrochloride (Uroxatral®), carbamazepine (Carbatrol®, Equetro®, Tegretol®), cisapride (Propulsid®), ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes), methylergonovine maleate (Ergotrate®, Methergine®), lovastatin (Advicor®, Altoprev®, Mevacor®), midazolam when taken by mouth, phenobarbital, phenytoin (Dilantin®, Phenytek®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®), sildenafil citrate (Revatio®) or tadalafil (Adcirca®) for the lung problem pulmonary artery hypertension (PAH), simvastatin (Zocor®, Vytorin®, Simcor®), St. John's wort (Hypericum perforatum) or products containing St. John’s wort, or triazolam (Halcion®)
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INCIVEK and other medicines can affect each other. Your healthcare provider may need to change the amount of medicines you take.

What should I tell my healthcare provider before taking 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, HIV infection, or any problems with your immune system
  • have a 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

How should I take INCIVEK?

Do not take INCIVEK alone to treat chronic hepatitis C infection. It must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.

Take INCIVEK exactly as your healthcare provider tells you. Do not stop taking INCIVEK unless your healthcare provider tells you to. If your healthcare provider tells you to stop, you should not start taking it again, even if the reason for stopping goes away. If you take too much INCIVEK, call your healthcare provider or local Poison Control Center, or go to the nearest emergency room right away.

Common Side Effects of INCIVEK Combination Treatment

The most common side effects 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, and tiredness. Tell your healthcare provider about any side effect that bothers you or doesn't go away.

These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.

Please see the full Prescribing Information for INCIVEK, including Boxed Warning, and read the Medication Guide.

Please see the full Prescribing Information and read the Medication Guides for peginterferon alfa and ribavirin.

This site is intended for U.S. audiences only. All other audiences please click here.
Incivek

Your browser (Internet Explorer 6) is out of date.

For the best experience using this website, please upgrade your web browser.

Incivek

You are now leaving www.INCIVEK.com.

The link you've chosen will take you to a site maintained by a third party that is solely responsible for its content. Vertex Pharmaceuticals Incorporated does not control, influence, or endorse this site and is not responsible for the privacy policy of any third-party websites.