Incivek

Pronunciation: tel-A-pre-vir
Generic Name: Telaprevir
Brand Name: Incivek

Incivek is used for:

Treating chronic hepatitis C virus infection in certain patients. It must be used in combination with peginterferon and ribavirin.

Incivek is a hepatitis C virus protease inhibitor. It reduces the amount of hepatitis C virus in the body by preventing the spread of the hepatitis C virus within the body.

Do NOT use Incivek if:

• you are allergic to any ingredient in Incivek


• you have moderate to severe liver problems


• you are taking alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cabazitaxel, cisapride, conivaptan, dronedarone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), lurasidone, pimozide, rifabutin, rifampin, rivaroxaban, silodosin, St. John's wort, or tolvaptan


• you are taking sildenafil or tadalafil to treat pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Incivek:

Some medical conditions may interact with Incivek. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have HIV infection; other immune system problems; gout or high blood uric acid levels; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)


• if you have other liver problems (eg, hepatitis B infection)


• if you have had an organ transplant


• if you will be having surgery

Some MEDICINES MAY INTERACT with Incivek. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifabutin, rifampin, or St. John's wort because they may decrease Incivek's effectiveness


• Alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cabazitaxel, cisapride, conivaptan, dronedarone , ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), lurasidone, pimozide, rivaroxaban, silodosin, or tolvaptan because the risk of their side effects may be increased by Incivek


• Sildenafil or tadalafil (when used to treat PAH) because the risk of their side effects may be increased by Incivek


• Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Incivek


• Many prescription medicines (eg, used for asthma or breathing problems, anxiety, birth control, blood thinning, blood flow, cancer, diabetes, enlarged prostate, erectile dysfunction, gout, angina, heart problems, HIV, immune suppression, infection, inflammation, irregular heartbeat, high blood pressure, high cholesterol, mental or mood problems, pain (eg, narcotics), PAH, seizures, sleep) may interact with Incivek, increasing the risk of side effects or decreasing effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Incivek may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Incivek:

Use Incivek as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Incivek comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Incivek refilled.


• Incivek must be taken with peginterferon and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.


• Take Incivek by mouth with food (not low fat). Eat a meal or snack that contains about 20 grams of fat within 30 minutes before you take Incivek. Examples of some foods include: a bagel with cream cheese, 1 cup nuts, 3 tablespoons peanut butter, 1 cup ice cream; 2 ounces American or cheddar cheese, 2 ounces potato chips, or 1 cup trail mix.


• Incivek works best if it is taken at the same time each day. Each dose should be taken 7 to 9 hours apart.


• Continue to take Incivek even if you feel well. Do not miss any doses.


• If you miss a dose of Incivek and you remember within 4 hours of when you usually take it, take the missed dose with food as soon as possible and go back to your regular dosing schedule. If you miss a dose of Incivek and it is more than 4 hours after the time you usually take it, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Incivek.

Important safety information:

• Mild skin rashes are common with the use of Incivek. Sometimes these skin rashes and other skin reactions can become severe. Contact your doctor right away if you develop a rash with or without itching; fever; mouth sores or ulcers; red or irritated eyes; red, swollen, blistered, or peeling skin; or swelling of the face.


• Incivek may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Incivek may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Incivek does not stop you from spreading hepatitis C virus to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have hepatitis C virus infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors.


• Do not change your dose without checking with your doctor.


• Incivek is not a cure for hepatitis C virus infection. Remain under the care of your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Incivek, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Women who may become pregnant and men who use Incivek must use 2 effective forms of birth control while they take Incivek with ribavirin and for 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using Incivek and for up to 2 weeks after stopping Incivek. Talk with your doctor if you have questions about effective birth control.


• Lab tests, including complete blood cell counts, electrolyte levels, liver and kidney function, hepatitis C virus antibody levels, thyroid function, and uric acid levels, may be performed while you use Incivek and for several months after you stop Incivek. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Incivek with caution in the ELDERLY; they may be more sensitive to its effects.


• Incivek should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Incivek must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Incivek. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Incivek while you are pregnant. It is not known if Incivek is found in breast milk. Do not breast-feed while taking Incivek.

Possible side effects of Incivek:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anal or rectal problems (eg, burning, discomfort, itching, hemorrhoids); change in taste; diarrhea; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; dark, tarry, or bloody stools; dizziness; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; joint pain (especially in the big toe); mouth sores or ulcers; pale skin; rash (with or without itching); red or irritated eyes; red, swollen, blistered, or peeling skin; severe or prolonged nausea or vomiting; shortness of breath; swelling of the face; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Incivek side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms include change in taste; decreased appetite; diarrhea; headache; nausea; vomiting.

Proper storage of Incivek:

Store Incivek at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Once the bottle is opened, use within 28 days. Keep Incivek out of the reach of children and away from pets.

General information:

• If you have any questions about Incivek, please talk with your doctor, pharmacist, or other health care provider.


• Incivek is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Incivek. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Incivek resources

• Incivek Side Effects (in more detail)
• Incivek Use in Pregnancy & Breastfeeding
• Incivek Drug Interactions
• Incivek Support Group
• 1 Review for Incivek - Add your own review/rating

• Incivek Prescribing Information (FDA)


• Incivek Advanced Consumer (Micromedex) - Includes Dosage Information


• Incivek Consumer Overview


• Telaprevir Professional Patient Advice (Wolters Kluwer)

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