Generic Name: telaprevir (tel A pre vir)
Brand Names: Incivek

What is Incivek?

Incivek (telaprevir) is an antiviral medication that prevents certain virus cells from multiplying in your body. Incivek is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.

Incivek is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

Incivek may also be used for purposes not listed in this medication guide.

Important information

Do not take Incivek as your only medication to treat hepatitis C. Incivek must be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab). Read the medication guide or patient instructions provided with each medication in your combination therapy.

Do not change your doses or medication schedule without your doctor's advice. Incivek is given together with interferon alfa and ribavirin.

Ribavirin can cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa and ribavirin, and for at least 6 months after treatment ends.

Slideshow: Sovaldi and The Evolving Course of Hepatitis C Therapy

Incivek may cause a severe skin reaction. Call your doctor right away if you have a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

The following drugs should not be used while you are taking Incivek: alfuzosin (Uroxatral), cisapride (Propulsid), pimozide (Orap), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin, Juvisync), midazolam (Versed), triazolam (Halcion), sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension, St. John's wort, rifampin (Rifadin, Rifater, Rifamate), ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

There are many other drugs that can interact with Incivek. Tell your doctor about all medications you use.

Before taking this medicine

You should not use Incivek if you are allergic to telaprevir.

To make sure you can safely take Incivek, tell your doctor if you have any of these other conditions:

  • hepatitis B or liver problems other than hepatitis C;

  • kidney disease (or if you are on dialysis);

  • anemia (lack of red blood cells);

  • if you have had an organ transplant;

  • HIV or AIDS;

  • a history of gout; or

  • if you have ever used medicine to treat hepatitis in the past and it did not work.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with Incivek. The following drugs should not be used while you are taking Incivek:

  • alfuzosin (Uroxatral);

  • atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

  • cisapride (Propulsid);

  • pimozide (Orap);

  • midazolam (Versed) or triazolam (Halcion);

  • sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;

  • St. John's wort;

  • rifampin (Rifadin, Rifater, Rifamate); or

  • ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

FDA pregnancy category X. Incivek is given together with interferon alfa and ribavirin. Although Incivek is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

  • Use at least 2 non-hormonal forms of birth control while either sexual partner is using Incivek with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

  • If you are a woman, do not use Incivek with interferon alfa and ribavirin if you are pregnant.

  • If you are a man, do not use Incivek with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

  • Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking Incivek.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Incivek with interferon alfa and ribavirin.

It is not known whether telaprevir passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking Incivek.

How should I take Incivek?

Take Incivek exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take Incivek as your only medication to treat hepatitis C. Incivek must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant to Incivek if you do not take it in combination with other medicines your doctor has prescribed.

This combination treatment is usually given for 12 to 48 weeks. The usual dose of Incivek is 2 tablets taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.

Take Incivek within 30 minutes after eating a meal or snack that contains about 20 grams of fat. Always take Incivek with food. Examples of snacks that contain about 20 grams of fat include: A bagel and cream cheese, 3 tablespoons of peanut butter, 2 ounces of American or cheddar cheese, 2 ounces of potato chips, a half-cup of nuts or trail mix, or 1 cup of ice cream.

Your total daily dose of 6 tablets is contained in a single blister strip of Incivek. A package of Incivek contains 4 cartons of 7 blister strips for a 4-week supply.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using Incivek. You may need to stop using the medicine for a short time. Do not stop taking this medication unless your doctor tells you to. If you stop taking Incivek for any reason, do not start taking it again without your doctor's advice.

Store Incivek at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 4 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Incivek side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Incivek: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Incivek side effects may include:

  • tired feeling;

  • nausea, vomiting, diarrhea, altered sense of taste;

  • rectal itching, burning, or discomfort; or

  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Incivek?

Tell your doctor about all other medicines you use, especially:

  • an antibiotic or an antifungal medication;

  • an antidepressant;

  • anti-malaria drugs;

  • anti-psychotic medication;

  • asthma or allergy medication (including inhaled steroids);

  • birth control or hormone replacement therapy that contains estrogen or progesterone;

  • a blood thinner or medicine to prevent blood clots;

  • cancer medicine;

  • cholesterol-lowering drugs;

  • cold or allergy medicine that contains an antihistamine;

  • erectile dysfunction medicines (Viagra, Levitra, Cialis);

  • gout medication;

  • heart or blood pressure medication, heart rhythm medication;

  • HIV/AIDS medications;

  • medicines used to prevent organ transplant rejection;

  • narcotic medication;

  • oral diabetes medication;

  • a sedative (Valium, Xanax, BuSpar, and others) or sleep medicine (Ambien);

  • seizure medication; or

  • steroids (dexamethasone, prednisone, and others).

This list is not complete and there are many other drugs that can interact with Incivek. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Incivek.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Incivek only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.02. Revision Date: 2012-04-15, PM.

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