Telaprevir, Oral teh-LA-pre-veer

What are other names for this medicine?

Type of medicine: HCV protease inhibitor

Generic and brand names: telaprevir, oral; Incivek

What is this medicine used for?

This medicine is taken by mouth to treat continuing (chronic) hepatitis C virus infections in adults. This medicine alone is not effective in the treatment of hepatitis C. Peginterferon and ribavirin must also be given in order for the treatment to be effective.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a blood disorder such as anemia
• a weakened immune system from diseases such as HIV/AIDS or from an organ transplant
• gout
• high cholesterol or high triglycerides
• liver disease other than hepatitis C

Tell your provider if you are scheduled to have surgery.

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, antipsychotics, sedatives, St. John's Wort, medicines for migraine headaches, and medicines to treat cholesterol, an enlarged prostate, or pulmonary hypertension.

Females of childbearing age: This medicine can cause birth defects. Read the information that comes in the medicine package. Your healthcare provider will check that you are not pregnant before starting this treatment, each month during treatment, and for 6 months after stopping treatment. Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Hormonal forms of birth control may not work as well during treatment with this medicine. Talk to your healthcare provider about effective forms of birth control. Stop taking this medicine at the first sign that you may be pregnant. If you think you may be pregnant while taking this medicine or within 6 months after stopping this medicine, contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Use 2 or more forms of an effective birth control method while you are taking this medicine and for 6 months after stopping it. Hormonal forms of birth control may not work as well during treatment with this medicine. Talk to your healthcare provider about effective forms of birth control. Contact your healthcare provider right away at the first sign that your sexual partner may be pregnant while you are taking this medicine or within 6 months after stopping this medicine. Do not use this medicine if your female partner is pregnant.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage on your own. Do NOT stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon. Do not run out of this medicine.

Take other medicines exactly as instructed by your healthcare provider.

Take this medicine with high fat meals or snacks. This helps the medicine work better. Ask your healthcare provider or pharmacist about anything you do not understand.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is less than 4 hours until the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, headache.

What should I watch out for?

This medicine may cause a serious skin reaction. Call your healthcare provider right away if you develop skin changes such as:

• swelling of your face
• red or inflamed eyes
• rash, with or without itching
• fever
• blisters or sores on your skin or in your mouth

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Unusual bruising or bleeding; unusual weakness or tiredness; shortness of breath; unusual dizziness; severe diarrhea; yellowing of eyes or skin severe itching; fever; redness, blisters, or peeling of the skin.

Other: Mild nausea, vomiting, diarrhea, mild skin rash, change in sense of taste, hemorrhoids.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alpha blockers such as alfuzosin (Urotraxal), silodosin (Rapaflo), and tamsulosin (Flomax)
• antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, metronidazole (Flagyl), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), rifapentine (Priftin), and telithromycin (Ketek)
• antidepressants such as citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), nefazodone, trazodone (Oleptro), trimipramine (Surmontil), and venlafaxine (Effexor, Effexor XR)
• antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (VFEND)
• anti-HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tenofovir (Viread)
• antipsychotic medicines such as aripiprazole (Abilify), haloperidol, lurasidone (Latuda), and pimozide (Orap)
• antiseizure medicines such as carbamazepine (Tegretol), clonazepam (Klonopin), ethosuximide (Zarontin), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
• boceprevir (Victrelis)
• cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor)
• cisapride
• colchicine (Colcrys)
• corticosteroids such as dexamethasone, hydrocortisone (Cortef), methylprednisolone (Medrol), and prednisone
• heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Tiazac), digoxin, disopyramide (Norpace), dronedarone (Multaq), eplerenone (Inspra), felodipine, flecainide (Tambocor), isradipine (DynaCirc CR), lidocaine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), propafenone (Rythmol), ranolazine (Ranexa), quinidine, and verapamil (Calan, Verelan)
• hormonal birth control such as pills, implants, shots, patches, or vaginal rings (talk to your healthcare provider if you need birth control)
• immunosuppressants such as cyclosporine (Sandimmune, Neoral, Gengraf), sirolimus (Rapamune), and tacrolimus (Prograf)
• medicines to treat breathing problems such as budesonide (Pulmicort, Rhinocort), fluticasone (Flovent, Flonase, Veramyst), mometasone (Asmanex, Nasonex), salmeterol (Serevent) and salmeterol/fluticasone (Advair)
• medicines to treat erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• medicines to treat low sodium such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• medicines to treat migraines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• medicines to treat or prevent blood clots such as dipyridamole (Persantine), cilostazol (Pletal), and warfarin (Coumadin)
• medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• methylergonovine (Methergine)
• nilotinib (Tasigna)
• pain medicines such as buprenorphine (Butrans, Subutex) and methadone (Dolophine)
• sedatives such as alprazolam (Xanax), buspirone (BuSpar), clorazepate (Tranxene), chlordiazepoxide (Librium), diazepam (Valium), eszopiclone (Lunesta), flurazepam, midazolam (Versed), triazolam (Halcion), and zolpidem (Ambien)
• St. John's wort
• stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• toremifene (Fareston)

The effects of this medicine may be increased if you take it with grapefruit juice. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.