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IMPORTANT SAFETY INFORMATION: INCIVEK combination treatment may cause serious side effects, including skin rash and serious skin reactions. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and it may lead to death. Call your healthcare provider right away if you develop any skin changes or itching during treatment with INCIVEK.

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION

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

Managing Side Effects

Be sure to talk with your healthcare provider right away about any side effect you have when you are on INCIVEK Triple Therapy. Never stop taking INCIVEK Triple Therapy without talking with your healthcare provider first. After all, that’s what they are there for: to help you along your treatment journey, no matter what comes up.

If you have questions about side effects, talk to your healthcare provider or call our toll-free 24/7 Nurse Support Line at
1-855-5-INCIVEK (1-855-546-2483).

The Nurse Support Line will not provide individual patient care or medical advice.

CLICK ON A TAB BELOW to learn more about side effects.

The list below does not include all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.

Serious and common side effects

Serious Side Effects

INCIVEK Triple Therapy may cause serious side effects, including:

Skin rash and serious skin reactions. Skin rashes are common with INCIVEK Triple Therapy. 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
  • 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 Triple Therapy 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

Common side effects of INCIVEK Triple Therapy

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.

Serious skin reactions/rash

Skin rash and serious skin reactions

Skin rashes are common with INCIVEK Triple Therapy.

  • In clinical trials, about half of the people developed a rash

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
  • 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 Triple Therapy without talking with your healthcare provider first.

Keeping skin healthy

It is important to keep your skin healthy during treatment. Here are some tips that others have found helpful in keeping their skin in good shape:

  • Apply moisturizers at least twice a day, including after bathing, when your skin is moist
  • Avoid alcohol-based lotions because they can dry out your skin
  • Drink plenty of water to help keep your skin moist
  • Wear loose-fitting clothing to help keep your skin cool
  • Keep rooms humidified and at a moderate temperature

Don’t forget to talk with your healthcare provider before trying any of these things. He or she may have additional tips for you. Remind your healthcare provider about any allergies you have.

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)
Anemia

Anemia

In clinical trials, about 1 out of 3 people had anemia (low red blood cell count). Anemia can be severe, so 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.

  • Anemia needs to be monitored and treated by your healthcare provider
  • If your anemia is severe, your healthcare provider may tell you to stop taking INCIVEK. If this happens, do not start taking it again
Anal or rectal symptoms

Anal and rectal symptoms

About 1 out of 4 people taking INCIVEK Triple Therapy in clinical trials developed anal or rectal problems. These include: hemorrhoids, discomfort or burning around or near the anus, itching around or near the anus, or diarrhea.

Here is how some people found relief:

  • Drink plenty of water and eat food that has fiber in it. Don’t have citrus, caffeine, or alcoholic drinks. They can make the problems worse
  • Keep the anal area dry. Pat it dry with cotton or gauze and sprinkle on cornstarch powder
  • Avoid more injury to the area. Cleaning the area too much, scrubbing, and scratching can make itchiness worse. Instead, use damp toilet paper or a wipe to clean the area

You might feel embarrassed to discuss anal and rectal problems, but it’s important that you do because your healthcare provider needs to know if you have any side effects. Your healthcare provider can recommend over-the-counter ointments, wipes, or other remedies.

Dehydration

Staying hydrated

It is important to stay hydrated with fluids during INCIVEK Triple Therapy. Dehydration occurs when you lose more fluid than you take in (eg, when exercising or if you have been vomiting or have severe diarrhea). When this occurs, your body doesn’t have enough water and other fluids to carry out its normal functions.

Signs and symptoms of dehydration include:

  • Increased thirst
  • Dry mouth
  • Decreased urine frequency or volume
  • Dark-colored urine

Ways to help you stay hydrated:

  • Keep a bottle of water with you and take regular sips even if you don’t feel thirsty
  • Drink a glass of water at meal times. Try to drink 8 glasses of water every day
  • If you are nauseous or have been vomiting, try small sips of ginger ale or ice chips

Call your healthcare provider right away if you experience any symptoms of dehydration, if you cannot drink fluids, eat, or if you have severe vomiting or diarrhea.

SOME GOOD NEWS: CHRONIC HEPATITIS C
CAN BE CURED IN MANY PATIENTS

With INCIVEK Triple Therapy, there's a better
chance for a cure* than with peginterferon alfa
and ribavirin alone.

Find out more

Support every step of the way

Vertex provides product support services and
educational resources for patients taking INCIVEK
that can help every step of the way.

Learn More

Meet Real Fighters

Get to know some of the real fighters who took on
the challenge and were cured* of chronic hepatitis C.
Their insights may help you in your own fight.

Get introduced

It is important to note that not everyone who took part in a
clinical trial was cured. The people shown in this website
share their own experiences; yours may be different.

*Cure, or clearing the virus, means the hepatitis C virus is
not detectable in your blood 6 months after you finish all
treatment. This is also known as Sustained Virologic
Response (SVR).

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?

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