Telaprevir (Oral)

Telaprevir is used along with injectable peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®) to treat chronic hepatitis C infection. These medicines are for patients with liver disease (including cirrhosis) who have not been treated before or who have tried other medicines that did not work well. Telaprevir is an antiviral agent.

This medicine was available only with your doctor's prescription.

Telaprevir was withdrawn from the United States market on October 16, 2014.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using them when his sexual partner becomes pregnant. If you become pregnant while using these medicines, tell your doctor right away.

To ensure you are not pregnant, your doctor may ask you to take 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. You must use two forms of birth control during treatment and for 6 months after treatment ends. You should test for pregnancy every month while using this medicine and for 6 months after your treatment ends.

Do not use the following medicines while you are using this medicine: 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®, Zocor®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using telaprevir with any of these medicines can cause very serious medical problems.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you develop a severe skin rash, blistering, peeling, or loosening of the skin, fever or chills, hives or welts, red skin lesions, acne, sores or ulcers on the skin, or yellowing of the skin or the whites of your eyes.

Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, trouble breathing, fever, swelling around the body, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.

Birth control pills may not work while you are using this medicine. To avoid getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Using this medicine with peginterferon alfa can temporarily lower the number of white blood cells in your blood, increasing the risk of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects like a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not change or suddenly stop using this medicine without first checking with your doctor.

This medicine will not prevent you from spreading hepatitis C to other people. Follow your doctor's instructions on how to prevent the spread of this infection.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medication, the chances of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of telaprevir in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of telaprevir have not been performed in the geriatric population, no geriatric-specific issues have been documented to date. However, elderly patients are more likely to have age-related liver issues, which may require caution in patients receiving telaprevir.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medication while breastfeeding.

Interactions with Drugs

Although certain drugs should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medicines is not advised. Your doctor may decide not to treat you with this drug or change some of the other drugs you take.

• Alfuzosin
• Alprazolam
• Bepridil
• Carbamazepine
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergonovine
• Ergotamine
• Finerenone
• Flibanserin
• Fluconazole
• Fosphenytoin
• Gepirone
• Isavuconazonium Sulfate
• Ivabradine
• Ketoconazole
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Methylergonovine
• Midazolam
• Naloxegol
• Nelfinavir
• Nimodipine
• Pacritinib
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimozide
• Piperaquine
• Primidone
• Rifampin
• Riociguat
• Romidepsin
• Saquinavir
• Sildenafil
• Simvastatin
• Sparfloxacin
• St John's Wort
• Tadalafil
• Terfenadine
• Thioridazine
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin
• Ziprasidone

Using this medication with any of the following medicines is usually not advised, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Alfentanil
• Amiodarone
• Amisulpride
• Amlodipine
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Bedaquiline
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Bosutinib
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Buserelin
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Cariprazine
• Ceritinib
• Chloroquine
• Cilostazol
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclophosphamide
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dienogest
• Digoxin
• Dihydrocodeine
• Docetaxel
• Domperidone
• Donepezil
• Drospirenone
• Duvelisib
• Elacestrant
• Elagolix
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Erlotinib
• Erythromycin
• Escitalopram
• Estradiol
• Eszopiclone
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etrasimod
• Everolimus
• Fedratinib
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluticasone
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fostemsavir
• Futibatinib
• Gestodene
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Histrelin
• Hydrocodone
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Ifosfamide
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levonorgestrel
• Lidocaine
• Lofexidine
• Lopinavir
• Lorlatinib
• Lumateperone
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methadone
• Methylprednisolone
• Metronidazole
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Neratinib
• Nifedipine
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Omaveloxolone
• Orlistat
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Palovarotene
• Panobinostat
• Paroxetine
• Pasireotide
• Pemigatinib
• Pentazocine
• Pexidartinib
• Pimavanserin
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Ponatinib
• Ponesimod
• Posaconazole
• Pralsetinib
• Prednisone
• Propafenone
• Quetiapine
• Quinidine
• Quizartinib
• Reboxetine
• Regorafenib
• Relugolix
• Retapamulin
• Ribociclib
• Rifabutin
• Rimegepant
• Rivaroxaban
• Rosuvastatin
• Ruxolitinib
• Salmeterol
• Segesterone
• Selpercatinib
• Selumetinib
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamsulosin
• Tazemetostat
• Telithromycin
• Tenofovir Alafenamide
• Tezacaftor
• Thiotepa
• Tipranavir
• Topotecan
• Trabectedin
• Tramadol
• Trazodone
• Triclabendazole
• Triptorelin
• Upadacitinib
• Valbenazine
• Vamorolone
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Zanubrutinib
• Zolpidem
• Zuclopenthixol
• Zuranolone

Using this medication with any of the following medications may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the medications.

• Atazanavir
• Efavirenz

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may as well cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical issues, especially:

• Anemia or
• Blood or bone marrow issues or
• Gout, history of or
• Weakened immune system (eg, HIV or AIDS)—Use with caution. May make these conditions worse.

• Liver disease, moderate to severe—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Chills
• Cough
• Fever
• Joint pain, stiffness, or swelling
• Lower back, side, or stomach pain
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin
• Rash
• Shortness of breath
• Sore throat
• Swelling of the feet or lower legs
• Troubled breathing with exertion
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Rare

• Blistering, peeling, or loosening of the skin
• Cloudy urine
• Dark urine
• Diarrhea
• Difficulty with breathing
• Drowsiness
• General tiredness and weakness
• Headache
• Itching
• Joint or muscle pain
• Light-colored stools
• Nausea or vomiting
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Swelling or puffiness of the face
• Unusual weight gain
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding with stools
• Uncomfortable swelling around the anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Incivek

Pharmacologic Class: Protease Inhibitor

To help clear up your infection completely, telaprevir must be taken together with peginterferon alfa and ribavirin for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, telaprevir must be used on a regular schedule.

Telaprevir should be taken within 30 minutes after eating a high-fat meal or snack (containing about 20 grams of fat). Ask your doctor about examples of food that you can eat that contain 20 grams of fat.

This medicine should come with a Medication Guide. Read and follow the information carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablet):For hepatitis C virus infection, in combination with peginterferon alfa and ribavirin: Adults—750 milligrams (mg) (two 375-mg tablets) 3 times a day with food. Each dose should be taken 7 to 9 hours apart. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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. Call your doctor if you have questions about this.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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