Generic Name: telaprevir (tel-A-pre-vir)
Brand Name: Incivek
Mild rashes are common in patients who take Incivek along with peginterferon and ribavirin. Serious and sometimes fatal skin reactions have also been reported. These reactions may also affect other areas of the body (eg, liver, kidney). Contact your doctor right away if you develop rash with or without itching; fever; mouth sores or ulcers; red or irritated eyes; red, swollen, blistered, or peeling skin; swelling of the face; change in the amount of urine produced; or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes). Discuss any questions or concerns with your doctor.
Incivek is used for:
Treating chronic hepatitis C virus (HCV) infection. It must be used in combination with peginterferon and ribavirin.
Incivek is an HCV protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV 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 pregnant or may become pregnant
- your sexual partner is pregnant
- you are taking alfuzosin, apixaban, avanafil, bosutinib, cabazitaxel, carbamazepine, cisapride, conivaptan, crizotinib, darunavir, dronedarone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), fosamprenavir, ivabradine, lomitapide, lopinavir, lovastatin, lurasidone, oral midazolam, phenobarbital, phenytoin, pimozide, regorafenib, rifabutin, rifampin, rivaroxaban, salmeterol, silodosin, simvastatin, St. John's wort, ticagrelor, tolvaptan, triazolam, or vincristine
- 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 able to become pregnant
- 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 liver problems other than HCV (eg, hepatitis B infection); HIV infection or other immune system problems; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)
- if you have a history of gout or high blood uric acid levels
- if you have had an organ transplant
- if you are dehydrated or 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:
- Many other prescription and nonprescription medicines (eg, used for abortion, allergies, angina, anxiety, asthma or other lung or breathing problems, birth control, blood flow problems, blood thinning, cancer, Cushing syndrome, cystic fibrosis, depression or other mental or mood problems, diabetes, enlarged prostate, erectile dysfunction, gout, high blood pressure, high cholesterol, HIV, immune suppression, infection, inflammation, irregular heartbeat or other heart problems, narcotic dependence, nausea and vomiting, overactive bladder, PAH, pain, seizures, sleep problems, stomach or bowel problems), multivitamin products, and herbal or dietary supplements because they may interact with Incivek. Ask your doctor or pharmacist if you are unsure if any of your medicines may interact with Incivek
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.
- Swallow Incivek whole. Do not break, crush, chew, cut, or dissolve before swallowing. If you cannot swallow Incivek whole, tell your doctor.
- 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. Discuss any concerns with your doctor.
- Drinking extra fluids while you are taking Incivek is recommended. Check with your doctor for instructions.
- Incivek works best if it is taken at the same time each day. Each dose should be taken 10 to 14 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 6 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 6 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:
- It is important to stay hydrated while you are taking Incivek. Contact your doctor if you have symptoms of dehydration (eg, increased thirst, dry mouth, change in the amount of urine produced, dark urine). Tell your doctor if you cannot drink fluids or eat.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- 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 HCV to others through sexual contact, sharing needles, or being exposed to your blood. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Talk with your health care provider about ways to prevent the spread of HCV to others. 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.
- Tell your doctor or dentist that you take Incivek before you receive any medical or dental care, emergency care, or surgery.
- 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, HCV 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.
- Incivek should be used with extreme caution in CHILDREN younger than 18 years old; 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 this medicine 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Anal or rectal problems (eg, burning, discomfort, itching, hemorrhoids); change in taste; diarrhea; nausea; tiredness; vomiting.
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; dizziness; fever, chills, or sore throat; joint pain (especially in the big toe); red, swollen, blistered, or peeling skin; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.
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.
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.Proper storage of Incivek:
Store Incivek at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Incivek out of the reach of children and away from pets.
- 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 should not be used to decide whether or not to take Incivek or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Incivek. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Incivek. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Incivek.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.