Incivek is an antiviral medicine that prevents certain virus cells from multiplying in your body.

Incivek is used in combination with peginterferon alfa and ribavirin to treat hepatitis C in adults.

Incivek may also be used for purposes not listed in this medication guide.

Incivek must be used in combination with peginterferon alfa and ribavirin.

Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.

Incivek with peginterferon alfa and ribavirin may cause a life-threatening skin reaction. Stop taking these medicines and call your doctor right away if you have a skin rash with other symptoms such as: fever, swelling in your face, redness in your eyes, mouth ulcers, skin sores, or blistering and peeling.

Incivek is used in combination with peginterferon alfa and ribavirin. Follow all directions on your prescription label. Your doctor may occasionally change your doses to make sure you get the best results. Do not take these medicines in larger or smaller amounts or for longer than recommended.

Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

Eat a meal or snack that contains about 20 grams of fat within 30 minutes before you take Incivek. Always take with food. Examples of snacks that contain about 20 grams of fat include: A bagel and cream cheese, 3 tablespoons of peanut butter, 2 ounces of American or cheddar cheese, 2 ounces of potato chips, a half-cup of nuts or trail mix, or 1 cup of ice cream.

Do not crush, chew, or break a Incivek tablet. Swallow it whole.

Your total daily dose of 6 tablets is contained in a single blister strip. A package of Incivek contains 4 cartons of 7 blister strips for a 4-week supply.

To be sure this medicine is helping your condition, you will need frequent blood tests. Treatment with Incivek may be discontinued based on the results of these tests.

Drink plenty of liquids while you are taking this medicine.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop taking this medicine unless your doctor tells you to. If you stop taking Incivek for any reason, do not start taking it again without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Hepatitis C:

1125 mg orally twice a day (10 to 14 hours apart) with food (not low fat)

Duration of therapy: 12 weeks in combination with peginterferon alfa and ribavirin

Comments:
-HCV-RNA levels should be monitored at weeks 4 and 12 to determine combination therapy duration and assess for treatment futility.

Approved indication: In combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in patients with compensated liver disease (including cirrhosis) who are therapy-naive or who have previously used interferon-based therapy, including prior null responders, partial responders, and relapsers

You should not use Incivek if you are allergic to telaprevir.

Incivek be used in combination with peginterferon alfa and ribavirin. Read the medication guide or patient instructions provided with each medicine you take. In some cases, you may not be able to use this drug combination.

To make sure Incivek is safe for you, tell your doctor if you have:

• liver problems other than hepatitis C (including hepatitis B);

• kidney disease (or if you are on dialysis);

• anemia (lack of red blood cells);

• HIV or AIDS;

• a history of gout;

• if you have had an organ transplant; or

• if you have ever used medicine to treat hepatitis in the past and it did not work.

Some medicines can cause unwanted or dangerous effects when used with Incivek. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;

• cisapride;

• pimozide;

• rifampin;

• St. John's wort;

• lovastatin, simvastatin;

• oral midazolam or triazolam;

• ergonovine, ergotamine, dihydroergotamine, methylergonovine;

• the seizure medications carbamazepine, phenobarbital, or phenytoin; or

• sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension.

FDA pregnancy category X. Incivek is given together with peginterferon alfa and ribavirin. Although Incivek is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.

• Use at least 2 non-hormonal forms of birth control while either sexual partner is using Incivek with peginterferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

• If you are a woman, do not use Incivek with peginterferon alfa and ribavirin if you are pregnant.

• If you are a man, do not use Incivek with peginterferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

• Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking Incivek.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Incivek with peginterferon alfa and ribavirin.

It is not known whether telaprevir passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking this medicine.

Take the missed dose as soon as you remember. If you are more than 6 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking this medicine will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have any of these signs of an allergic reaction to Incivek: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Incivek with peginterferon alfa and ribavirin may cause a life-threatening skin reaction. Stop taking these medicines and call your doctor right away if you have a skin rash with other symptoms such as: fever, swelling in your face, redness in your eyes, mouth ulcers, skin sores, or blistering and peeling.

Call your doctor at once if you have:

• fever, swollen glands, body aches, flu symptoms, pale skin, feeling light-headed or short of breath;

• easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

• upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• chest pain, irregular heart rhythm, feeling short of breath;

• heavy sweating, feeling very thirsty or hot, being unable to urinate, or hot and dry skin;

• confusion, nausea and vomiting, swelling, rapid weight gain, little or no urinating; or

• new or worsening cough with fever, trouble breathing.

Common Incivek side effects may include:

• tired feeling;

• nausea, vomiting, diarrhea, altered sense of taste;

• rectal itching, burning, or discomfort; or

• mild non-progressive skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with telaprevir. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Incivek, especially:

• bosentan, colchicine, escitalopram, fentanyl, methadone, repaglinide, zolpidem (Ambien), warfarin (Coumadin);

• birth control pills or hormone replacement therapy;

• sildenafil (Viagra) and other erectile dysfunction medicines;

• an antibiotic or antifungal medicine--clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, rifabutin, telithromycin, voriconazole; a sedative--alprazolam, trazodone; asthma or allergy medicine--budesonide, fluticasone, salmeterol (Advair, Serevent);

• cholesterol-lowering drugs--atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin; HIV or AIDS medicines--efavirenz, tenofovir, or ritonavir in combination with atazanavir, darunavir, fosamprenavir, or lopinavir;

• heart or blood pressure medicine--amlodipine, amiodarone, digoxin, diltiazem, felodipine, flecainide, nicardipine, nifedipine, nisoldipine, propafenone, quinidine, verapamil; or

• steroid medicine--dexamethasone, prednisone, methylprednisolone; medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.

This list is not complete and many other drugs can interact with telaprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.