Brand Name(s):

• Incivek®

IMPORTANT WARNING:

[Posted 12/19/2012]ISSUE:FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug telaprevir (Incivek) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). Some patients died when they continued to receive telaprevir combination treatment after developing a worsening, or progressive rash and systemic symptoms (symptoms affecting the entire body).

WHY is this medicine prescribed?

Telaprevir is used along with two other medications (ribavirin [Copegus, Rebetol] and peginterferon alfa [Pegasys]) to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in people who have not yet been treated for this condition or whose condition could not successfully be treated with ribavirin and peginterferon alfa alone. Telaprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Telaprevir may not prevent the spread of hepatitis C to other people.

HOW should this medicine be used?

Telaprevir comes as a tablet to take by mouth. It is usually taken three times a day (every 7 to 9 hours). You must eat a meal or snack that contains about 20 grams of fat within 30 minutes before you take telaprevir. Ask your doctor for examples of foods that contain 20 grams of fat that you can eat when you take telaprevir. Do not take telaprevir without food. Take telaprevir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take telaprevir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take telaprevir even if you feel well. Telaprevir must be taken in combination with peginterferon alfa and ribavirin, usually for 12 weeks. Peginterferon alfa and ribavirin are usually continued after treatment with telaprevir is finished. Do not stop taking telaprevir, peginterferon alfa, or ribavirin, unless told to do so by your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking telaprevir,

• tell your doctor and pharmacist if you are allergic to telaprevir, any other medications, or any of the ingredients in telaprevir tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking any of the following medications or herbal products: alfuzosin (Uroxatral); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), ergonovine, and methylergonovine (Methergine); cisapride (Propulsid)(no longer available in the US); lovastatin (Mevacor, in Advicor); midazolam (Versed) taken by mouth; pimozide (Orap); rifampin (Rifadin, Rimactane, in IsonaRif, in Rifamate, in Rifater); sildenafil (only Revatio brand used for lung disease); simvastatin (in Simcor, in Vytorin, Zocor); St. John's wort; triazolam (Halcion); and tadalafil (only Adcirca brand used for lung disease). Your doctor will probably tell you not to take telaprevir if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend); atorvastatin (Lipitor, in Caduet); bosentan ( Tracleer); budesonide (Pulmicort, Rhinocort); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), nicardipine (Cardene), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); clarithromycin (Biaxin); colchicine (Colcrys); desipramine (Norpramin); digoxin (Lanoxin); efavirenz (Sustiva, in Atripla); erythromycin (E.E.S., E-Mycin, others); escitalopram (Lexapro); fluticasone (Advair, Flonase, Flovent); hormone replacement therapy (HRT); immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf); medications for erectile dysfunction (ED) such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra, Staxyn); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), lidocaine (Lidoderm, Lidopen, Xylocaine), propafenone (Rhythmol), or quinidine; certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); methadone (Dolophine); midazolam injection (Versed); oral contraceptives ('birth control pills'); oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred); rifabutin (Mycobutin); ritonavir (Norvir) used in combination with other HIV protease inhibitors such as atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), and lopinavir (in Kaletra); salmeterol (Serevent, in Advair); telithromycin (Ketek); tenofovir (Viread, in Truvada and Atripta); trazodone; and zolpidem (Ambien). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with telaprevir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have ever had an organ transplant and if you have or have ever had anemia (not enough red blood cells in the blood to carry oxygen to the rest of the body), gout (attacks of joint pain caused by high levels of uric acid in the blood), human immunodeficiency virus (HIV), problems with your immune system, hepatitis B (HBV) or liver disease other than hepatitis C, or kidney disease.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking telaprevir.
• tell your doctor if you are pregnant, plan to become pregnant, or can possibly become pregnant. If you are male, tell your doctor if your partner is pregnant, plans to become pregnant, or can possibly become pregnant. Telaprevir must be taken with ribavirin which can harm the fetus. You must use two methods of birth control to prevent pregnancy in you or your partner during your treatment with these medications and for 6 months after your treatment. Talk to your doctor about which methods you should use; hormonal contraceptives (birth control pills, patches, implants, rings, or injections) may not work well in women who are taking these medications. You or your partner must be tested for pregnancy every month during your treatment and for 6 months after your treatment. If you or your partner become pregnant while taking these medications, call your doctor immediately.
• tell your doctor if you are breast-feeding.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you remember the missed dose within 4 hours of the time you were scheduled to take it, take the missed dose with a snack or meal (containing about 20 grams of fat) right away. However, if it is more than 4 hours since you were to take the dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). After a bottle of telaprevir is first opened, the medication must be used within 28 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• nausea
• diarrhea
• vomiting
• headache
• loss of appetite
• changes in taste

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to telaprevir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2013.