TELAPREVIR

(tel A pre vir) Brand: Incivek

What is the most significant information I must know about telaprevir?

• Do not take telaprevir as your only medicine to treat hepatitis C. Telaprevir should be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab).

• Read the medicine manual or patient instructions provided with every medicine in your combination therapy. Do not change your doses or medicine schedule without your doctor's advice.

• Telaprevir is given together with interferon alfa and ribavirin. Ribavirin can reason birth defects or death in an unborn child. 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.

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

• The next drugs must not be used while you are taking telaprevir: 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 much another drugs that can interact with telaprevir. Speak your doctor about all medications you use.

What is telaprevir?

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

• Read the medicine manual or patient instructions provided with every medicine in your combination therapy. Do not change your doses or medicine schedule without your doctor's advice. Each face with hepatitis C must stay under the care of a doctor.

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

• Telaprevir may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking telaprevir?

• You must not use telaprevir if you are allergic to it.

• To create certain you can safely take telaprevir, speak your doctor if you have any of these another conditions:

· hepatitis B or liver problems another than hepatitis C;

· kidney malady (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 medication to treat hepatitis in the past and it did not work.

• There are much another drugs that can reason serious or life threatening medical problems if you take them together with telaprevir. The next drugs must not be used while you are taking telaprevir:

· 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. Telaprevir is given together with interferon alfa and ribavirin. Although telaprevir is not expected to harm an unborn child, ribavirin is known to reason birth defects or death in an unborn child. 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 till using these medications and each month during your treatment.

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

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

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

· Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective satis 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 telaprevir.

· Speak your doctor right away if a pregnancy occurs while either the mother or the father is using telaprevir with interferon alfa and ribavirin.

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

How must I take telaprevir?

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

• Do not take telaprevir as your only medicine to treat hepatitis C. Telaprevir should be used in combination with peginterferon alfa and ribavirin. Your malady may become resistant to telaprevir if you do not take it in combination with another medicines your doctor has prescribed.

• This combination treatment is generally given for 12 to 48 weeks. The normal doze of telaprevir is 2 tablets taken 3 times for day, each 7 to 9 hours. Follow your doctor's instructions.

• Take telaprevir within 30 minutes after eating a meal or snack that contains about 20 grams of thick. Always take telaprevir with food. Examples of snacks that contain about 20 grams of thick 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 doze of 6 tablets is contained in a single blister strip of telaprevir. A package of telaprevir contains 4 cartons of 7 blister strips for a 4-week supply.

• To be certain this medication is helping your condition and is not causing deleterious effects, your blood will need to be tested often. Visit your doctor regularly.

• If you need surgery, speak the surgeon onward of time that you are using telaprevir. You may need to stop using the medication for a short time.

• Do not stop taking this medicine unless your doctor tells you to. If you stop taking telaprevir for any cause, do not start taking it again without your doctor's advice.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• If you are smaller than 4 hours late in taking your medication, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal 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 medicine guide.

What must I avoid while taking telaprevir?

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

What are the possible side effects of telaprevir?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, 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 course, trouble concentrating; or

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

• Smaller serious side effects may include:

· weary 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect telaprevir?

• Speak your doctor about all another medicines you use, especially:

· an antibiotic or an antifungal medication;

· an antidepressant;

· anti-malaria drugs;

· anti-psychotic medication;

· asthma or allergy medicine (including inhaled steroids);

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

· a blood thinner or medication to prevent blood clots;

· cancer medicine;

· cholesterol-lowering drugs;

· cool or allergy medication that contains an antihistamine;

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

· gout medication;

· heart or blood pressure medicine, 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 medication (Ambien);

· seizure medicine; or

· steroids (dexamethasone, prednisone, and others).

• This list is not complete and there are much another drugs that can interact with telaprevir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor. Hold 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 telaprevir.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.