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 additional Important Safety Information.

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

What is INCIVEK Triple Therapy?
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 approved for any other genotype. Ask your healthcare provider what genotype you are.

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, 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 are the possible side effects of INCIVEK Triple Therapy?
INCIVEK combination treatment may cause serious side effects, including:

Skin rash and serious skin reactions

  • 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.

Anemia

  • 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.

Pregnancy

  • 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.

You can read more about these serious side effects by visiting the Side Effects page.

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.
How can I prevent pregnancy while on treatment?
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.
What should I tell my healthcare provider before taking INCIVEK Triple Therapy?
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
  • 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

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. 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.
Can INCIVEK be taken alone?
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.
How should I take INCIVEK?
  • Do not stop taking INCIVEK unless your healthcare provider tells you to. If you think there is a reason to stop taking INCIVEK, talk with 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, call your healthcare provider or local Poison Control Center, or go to the nearest hospital emergency room right away
What kind of food should I eat when taking INCIVEK?
If you take INCIVEK on an empty stomach, you may not get enough medicine in your blood to clear the virus. That's why it's important to eat a meal or snack (that contains about 20 grams of fat) within 30 minutes of taking each dose of INCIVEK. The food you eat with INCIVEK should NOT be low-fat.

Examples of foods that contain about 20 grams of fat that could be eaten with INCIVEK include:
  • Bagel with cream cheese
  • 1/2 cup nuts
  • 3 tablespoons peanut butter
  • 1 cup ice cream
  • 2 ounces American or Cheddar cheese
  • 2 ounces potato chips
  • 1/2 cup trail mix

Of course, don't eat any foods that you are allergic to. Also, keep in mind any dietary restrictions you may have.

Learn more about Foods to eat with INCIVEK.
Why do I have to take INCIVEK regularly?
For INCIVEK to work, you need to have a steady amount of it in your body. You have to take it exactly at the times that your healthcare provider tells you to. This way, your body will continue to have just the right amount of medicine throughout the day.
What should I do if I forget to take INCIVEK® (telaprevir)?
Talk to your healthcare provider right away if you forget to take your INCIVEK. He or she will advise you on what to do.
How long will my INCIVEK Triple Therapy last?
Take your medicine for as long as your healthcare provider tells you to. Don't stop taking INCIVEK, or any of your medicines, without first talking to your healthcare provider. Generally, your treatment will be as follows:

  • For the first 12 weeks of therapy, you will take INCIVEK with peginterferon alfa and ribavirin (starting all 3 medicines on the same day)
  • After that 12-week period, you will stop taking INCIVEK, but will continue taking peginterferon alfa and ribavirin alone for another 12 or 36 weeks depending on your treatment history and response
  • You will have blood tests to check how much of the virus is in your blood (viral load) throughout your treatment, including at weeks 4, 12, and 24. These blood tests will determine how INCIVEK Triple Therapy is working for you. Based on these results and your treatment history, your healthcare provider will either:
    • Continue your treatment if it is working and decide how long your treatment will be
    • Stop your treatment if it is not working
  • During your treatment, your healthcare provider will order other tests to check on your general health. This will include regular blood tests to check your blood cell counts during treatment
Will I need to have blood tests, and if so, how often?
Yes, you will need to have regular blood tests. These will measure the amount of the virus in your blood. This is important, as it will help your healthcare provider make decisions about your treatment. Your healthcare provider will also order additional blood tests throughout treatment to monitor your health. This will include regular blood tests to check your blood cell counts during treatment.

Talk to your healthcare provider if you have any questions about your lab tests.
Can I infect another person with the hepatitis C virus during treatment?
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.
How can I relieve itching without scratching?
If your skin feels itchy and you want to scratch it, instead try to:
  • Pat the itchy area with the flat of your hand
  • Pinch the itchy area with your fingertips (not too hard)
  • Put something cold on the itchy area (like ice cubes or frozen peas, wrapped in a towel or cloth)

For tips on how to keep your skin healthy during treatment, visit the INCIVEK Side Effects page or call the 24-hour toll-free Vertex GPS nurse hotline at 1-855-280-1650.
How should I store INCIVEK?
INCIVEK does not need to be refrigerated. Store your INCIVEK tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep INCIVEK and all medicines out of the reach of children.
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.
How do I know if my health insurance will cover INCIVEK combination treatment?
Trained reimbursement specialists are available by calling the toll-free Vertex GPS number at 1-855-VERTEX-GPS (1-855-837-8394) Monday through Friday, from 8:30 AM to 8 PM EST. These specialists can explain your prescription drug benefits and help you file an appeal if your INCIVEK claim is rejected.
Can I get financial support for INCIVEK treatment?
There are financial assistance programs for eligible people on treatment with INCIVEK. You can find out more by visiting the Vertex GPS: Guidance & Patient Support page, or by calling 1-855-280-1650.

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.