Telaprevir

Generic name: Telaprevir
Drug class: Protease inhibitors

Usage of Telaprevir

Telaprevir is used in combination with injectable Peginterferon Alfa (Pegasys®, PegIntron®) and ribavirin (Copegus®, Rebetol®) to treat chronic hepatitis C infection. These medicines are used in patients with liver disease (including cirrhosis) who have not been treated before or who have received 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Telaprevir was withdrawn from the United States market on October 16, 2014.

Telaprevir side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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. Also, your health care professional may be able to tell you about 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.

Before taking Telaprevir

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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 problems have been documented to date. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving telaprevir.

Breast Feeding

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

Interactions with Medicines

Although certain medicines 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 taking this medicine, 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 medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines 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 medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often 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 medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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 also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Telaprevir

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.

Warnings

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

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

To make sure you are not pregnant, 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.

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 have 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, difficulty with breathing, fever, general body swelling, 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 keep from 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 chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get 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 recommend 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 you are using sharp objects such as a safety razor or fingernail or toenail cutters.

Avoid contact sports or other situations where bruising or injury could occur.

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

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.

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

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