Telaprevir (By mouth)

Introduction

Telaprevir (tel-A-pre-vir)

vvvTreats hepatitis C. Used together with peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®).

Brand Name(s)

Incivek

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to telaprevir or if you have moderate to severe liver disease. Do not use this medicine with ribavirin if you are pregnant or breastfeeding or if your partner is pregnant. Do not use this medicine together with the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), St John's wort, tadalafil (Adcirca®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, or Zocor®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, DHE 45®, Ergomar®, Ergotrate®, or Methergine®).

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Telaprevir is always used together with other medicines 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. The food should contain about 20 grams of fat. Take the tablet within 30 minutes after you eat. Ask your doctor about the types of high-fat food you can eat.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide 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 away from children and 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, Cardioquin®, Cordarone®, Quinaglute®, Rythmol®, Tambocor®, or Vascor®), certain blood pressure medicine (such as amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil, Adalat®, Calan®, Cardene®, Cardizem®, Norvasc®, Plendil®, Sular®, or Verelan®), medicine to treat an infection (such as clarithromycin, erythromycin, ketoconazole, itraconazole, posaconazole, telithromycin, voriconazole, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, Sporanox®, or Vfend®), or a blood thinner (such as warfarin or Coumadin®).
• Tell your doctor if you also use medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), medicine to treat depression (such as desipramine, escitalopram, trazodone, Desyrel®, Lexapro®, or Norpramin®), medicine for sleeping (such as zolpidem or Ambien®), medicine to treat HIV or AIDS (such as atazanavir, darunavir, efavirenz, fosamprenavir, lopinavir, ritonavir, tenofovir, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®, Sustiva®, or Viread®), medicine to treat impotence (such as sildenafil, tadalafil, vardenafil, Cialis®, Levitra®, or Viagra®), alprazolam (Xanax®), atorvastatin (Lipitor®), bosentan (Tracleer®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), methadone (Dolophine®), midazolam injection, sirolimus (Rapamune®), tacrolimus (Prograf®), or birth control pills (such as ethinyl estradiol, norethindrone, or 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, Decadron®, Flonase®, Medrol®, Pulmicort®, or Rhinocort®).

Warnings While Using This Medicine

• You can harm your unborn baby if you use this medicine together with ribavirin while you are pregnant. These medicines 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 while you are using these medicines.
• Your doctor may ask you to have a pregnancy test before you start using this medicine. You must have a negative pregnancy test before you will be allowed to use this medicine with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using this medicine and for 6 months after your treatment ends.
• Make sure your doctor knows if you have kidney disease, 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 allergic reactions can occur with this medicine. Tell your doctor right away if you have blistering or peeling skin, fever or chills, red skin lesions, a severe rash or acne, sores or ulcers on the skin, or yellow skin or eyes.
• Check with your doctor right away if you have unusual bleeding or bruising, pale skin, trouble breathing, or feel tired or weak. These could be symptoms of anemia.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Birth control pills may not work while you are using this medicine. To avoid pregnancy, use 2 other forms of birth control.
• Do not stop using this medicine without checking first with your doctor.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to 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, or red skin rash
• Bloody or cloudy urine
• Fever, chills, cough, sore throat, and body aches
• Sores, ulcers, or white spots in your mouth or on your lips
• Swelling of the face, hands, feet, or lower legs
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

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

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