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Incivek

GENERIC NAME(S): TELAPREVIR

WARNINGS:

Patients receiving telaprevir combination therapy have rarely experienced very serious (possibly fatal) skin reactions. Seek immediate medical attention if you develop any of the following symptoms of a skin reaction: skin rash/blisters/peeling, itching, swelling of your face, sores, eye redness, or fever.

Skin rash commonly occurs in patients taking telaprevir. Your doctor will determine if you need treatment for your skin rash or if you need to stop taking telaprevir, or any of your other medications. Never stop taking your medications without talking to doctor or pharmacist first. If you have stopped taking telaprevir due to a rash, you must never take telaprevir again. Ask your doctor or pharmacist for more details.

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Uses

Telaprevir is an antiviral used in combination with peginterferon and ribavirin to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Telaprevir is a protease inhibitor. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

This combination reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safe sex" (including the use of latex condoms/dental dams) to lower the risk of passing the virus to others.

Do not use telaprevir alone to treat hepatitis C.

How to use Incivek

Read the Medication Guide provided by your pharmacist before you start taking telaprevir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily (every 10 to 14 hours). Telaprevir must be taken with food so your body can absorb it properly, so eat a meal or snack that contains at least 20 grams of fat within 30 minutes of taking your dose. Ask your doctor or pharmacist about what kinds of food have the right amount of fat to improve the absorption of telaprevir.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking.

Telaprevir works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Continue to take this medication until the full prescribed amount is finished. Do not change your dose, skip any doses, or stop this medication early without your doctor's approval.

Side Effects

See also Warning section.

Nausea, vomiting, diarrhea, hemorrhoids, rectal itching/burning/discomfort, or change in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, rapid breathing, shortness of breath.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking telaprevir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Telaprevir, in combination with peginterferon and ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may cause harm to an unborn baby. Two reliable forms of birth control must be used whenever at least one sexual partner is using these medicines, and for six months after stopping treatment (see also Drug Interactions section). If you or your partner become pregnant, or if you think you or your partner may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of telaprevir from your body, which may affect how telaprevir works. Examples include azole antifungals (such as itraconazole), efavirenz, etravirine, lopinavir/ritonavir, macrolide antibiotics (such as erythromycin), nevirapine, certain anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), rifamycins (such as rifabutin), St. John's wort, among others.

Telaprevir can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfuzosin, colchicine, drospirenone, lurasidone, pimozide, tacrolimus, ticagrelor, ergots (such as dihydroergotamine, ergotamine), drugs for irregular heartbeat (such as amiodarone, quinidine), HIV protease inhibitors (such as atazanavir, darunavir, fosamprenavir), certain statins (atorvastatin, lovastatin, simvastatin), sedatives (such as midazolam, triazolam), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil, vardenafil), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function tests, complete blood counts, hepatitis C virus RNA levels, uric acid levels) will be performed before starting and periodically while you are taking this medication to monitor your progress or check for side effects. Consult your doctor for more details.

It is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while using this medication and for 6 months after treatment ends to make sure no pregnancy occurs.

Missed Dose

If you miss a dose and it is within 4 hours from the time you usually take the dose, take it with food as soon as you remember. If it more than 4 hours after the time you usually take the dose, then skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Once the bottle is opened, the medication is good for 28 days. Discard any unused portion after that time. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Images

INCIVEK 375 MG TABLET
INCIVEK 375 MG TABLET
View Larger Picture
color
purple
shape
oblong
imprint
V 375
INCIVEK 375 MG TABLET
INCIVEK 375 MG TABLET

Identification

color
purple
shape
oblong
imprint
V 375
This medicine is a purple, oblong, film-coated tablet imprinted with "V 375".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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