Telaprevir (tel-A-pre-vir)

Treats hepatitis C. Used together with peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®). This medicine was withdrawn from the United States market on October 16, 2014.

Brand Name(s):

Incivek

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Telaprevir is always used together with ribavirin and peginterferon alfa to treat hepatitis C infection. Use all of the medicines your doctor prescribed and make sure you understand when to take them during the day.
• Take the tablet with a high-fat meal or snack, such as a bagel with cream cheese, 1/2 cup of nuts, or 3 tablespoons of peanut butter. The food should contain about 20 grams of fat. Take the tablet within 30 minutes after you eat. Ask your doctor about other types of high-fat food you can eat.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

• If you miss a dose or forget to take your medicine and it is less than 4 hours from the time your regular dose was scheduled, take the tablet as soon as you can. If you miss a dose and it is more than 4 hours from the time your regular dose was scheduled, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose. Call your doctor if you have questions about this.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use digoxin (Lanoxin®), medicine for heart rhythm problems (such as amiodarone, bepridil, flecainide, lidocaine, propafenone, quinidine, Cordarone®, Tambocor™), certain blood pressure medicine (such as amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil, Cardene®, Cardizem®, Norvasc®), medicine to treat an infection (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
• Tell your doctor if you also use medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®), medicine to treat depression (such as escitalopram, trazodone, Lexapro®), medicine for sleeping (such as zolpidem, Ambien®), medicine to treat HIV or AIDS (such as atazanavir, darunavir, efavirenz, fosamprenavir, lopinavir, ritonavir, tenofovir, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®, Sustiva®, Viread®), medicine to treat impotence (such as sildenafil, tadalafil, vardenafil, Cialis®, Levitra®, Viagra®), medicine to lower cholesterol (such as atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, Crestor®, Lipitor®), alprazolam (Xanax®), bosentan (Tracleer®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), methadone (Dolophine®), midazolam injection, repaglinide (Prandin®), sirolimus (Rapamune®), tacrolimus (Prograf®), or birth control pills (such as ethinyl estradiol, norethindrone, Estinyl®).
• Make sure your doctor knows if you also use colchicine (Colcrys®), rifabutin (Mycobutin®), salmeterol (Serevent®), or a steroid medicine (such as budesonide, dexamethasone, fluticasone, methylprednisolone, prednisone, Flonase®, Medrol®).

Warnings While Using This Medicine:

• You can harm your unborn baby if you use this medicine while you are pregnant. This medicine may also cause birth defects if the father is using it when his partner becomes pregnant. Tell your doctor right away if a pregnancy occurs.
• You must have a negative pregnancy test before you will be allowed to use this medicine. You should test for pregnancy every month while you use this medicine and for 6 months after treatment ends.
• You must use 2 forms of birth control during treatment and for 6 months after treatment ends. Birth control pills may not work while you are using this medicine, so you must use 2 other forms of birth control. Birth control pills may be used as 1 type of birth control, beginning 2 weeks after your treatment is over.
• Make sure your doctor knows if you are breastfeeding, or have kidney disease, other liver disease (including hepatitis B), blood or bone marrow problems (such as anemia), gout, HIV/AIDS, or other immune system problems. Tell your doctor if you have had an organ transplant.
• Serious skin reactions can occur with this medicine. Tell your doctor right away if you have any skin changes, such as severe rash or open sores, blistering or peeling skin, fever, cough, pink eye, or face swelling.
• Check with your doctor right away if you have unusual bleeding or bruising, pale skin, trouble breathing, or if you feel tired or weak. These could be symptoms of anemia.
• Do not stop using this medicine unless directed by your doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• This medicine will not keep you from giving hepatitis C to other people. Follow your doctor's instructions about how to prevent the spread of this infection.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Fever, pink eye, cough, headache, and body aches
• Sores or ulcers in your mouth or on your lips
• Swelling of the face
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Changes in taste
• Diarrhea, nausea, vomiting
• Discomfort, swelling, or burning feeling around the anus
• Mild rash, itching skin
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088