What is INCIVEK for?

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

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^®), atorvastatin (Lipitor^®, Caduet^®), ergot containing medicines such as methylergonovine (Methergine^®), lovastatin (Advicor^®, Altoprev^®, Mevacor^®), 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 triazolam (Halcion^®).

Talk to your healthcare provider before taking INCIVEK if any of the above applies to you. Your healthcare provider may need to change the amount of medicines you take.

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.

Serious Side Effects

INCIVEK can cause serious side effects, including:

• 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.
  
  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.
  
  
• 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 these symptoms: 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, or fever.
  
  Your healthcare provider will decide if these changes may be a sign of a serious skin reaction. Your healthcare provider will also decide if you need treatment for your rash or to stop INCIVEK or your other medicines. Never stop taking INCIVEK combination treatment without talking to your healthcare provider first.
  
  
• 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.
  
  
• 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.
  

What should I tell my healthcare provider before taking INCIVEK?

Tell your healthcare provider if you:

• have certain blood problems such as 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?

Take INCIVEK exactly as your healthcare provider tells you. Take 2 INCIVEK pills 3 times a day, 7 to 9 hours apart, with food. Eat a meal or snack containing about 20 grams of fat within 30 minutes before you take each dose. Talk to your healthcare provider about examples of food you can eat.

If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible. 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 time. 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 the Medication Guide.

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