Telaprevir

Telaprevir is used along with two other medications (ribavirin [Copegus, Rebetol] and peginterferon alfa [Pegasys]) to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in people who have not yet been treated for this condition or whose condition could not successfully be treated with ribavirin and peginterferon alfa alone. Telaprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Telaprevir may not prevent the spread of hepatitis C to other people.

Telaprevir is an antiviral medicine that prevents certain virus cells from multiplying in your body.

Telaprevir is used in combination with peginterferon alfa and ribavirin to treat hepatitis C in adults.

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

Telaprevir must be used in combination with peginterferon alfa and ribavirin.

Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.

Telaprevir with peginterferon alfa and ribavirin may cause a life-threatening skin reaction. Stop taking these medicines and call your doctor right away if you have a skin rash with other symptoms such as: fever, swelling in your face, redness in your eyes, mouth ulcers, skin sores, or blistering and peeling.

You should not use telaprevir if you are allergic to it. Telaprevir must be used in combination with peginterferon alfa and ribavirin. Read the medication guide or patient instructions provided with each medicine you take. In some cases, you may not be able to use this drug combination.

To make sure telaprevir is safe for you, tell your doctor if you have:

• liver problems other than hepatitis C (including hepatitis B);
• kidney disease (or if you are on dialysis);
• anemia (lack of red blood cells);
• HIV or AIDS;
• a history of gout;
• if you have had an organ transplant; or
• if you have ever used medicine to treat hepatitis in the past and it did not work.

Some medicines can cause unwanted or dangerous effects when used with telaprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin, cisapride, pimozide, rifampin, St. John's wort;
• lovastatin, simvastatin;
• oral midazolam or triazolam;
• ergonovine, ergotamine, dihydroergotamine, methylergonovine;
• the seizure medications carbamazepine, phenobarbital, or phenytoin; or
• sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension.

FDA pregnancy category X. Telaprevir is given together with peginterferon alfa and ribavirin. Although telaprevir 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.

• Use at least 2 non-hormonal forms of birth control while either sexual partner is using telaprevir with peginterferon 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 telaprevir with peginterferon alfa and ribavirin if you are pregnant.
• If you are a man, do not use telaprevir with peginterferon 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 telaprevir.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using telaprevir with peginterferon 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 telaprevir.

• Take telaprevir exactly as your healthcare provider tells you. Your healthcare provider will tell you how much telaprevir to take and when to take it.
• Take telaprevir 3 times a day. Each dose should be taken 7 to 9 hours apart. Eat a meal or snack that contains about 20 grams of fat, within 30 minutes before you take each dose of telaprevir. Talk to your healthcare provider about examples of foods that you can eat that contain about 20 grams of fat. Always take telaprevir with food.
• If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible.
• If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose at your normal dosing schedule.
• Do not stop taking telaprevir unless your healthcare provider tells you to. If you think there is a reason to stop taking telaprevir, talk to your healthcare provider before doing so.
• If your healthcare provider tells you to stop taking telaprevir, you should not start taking it again even if the reason for stopping goes away.
• If you take too much telaprevir or overdose, call your healthcare provider or local Poison Control Center, or go to the nearest hospital emergency room right away.

WARNING:

SERIOUS SKIN REACTIONS

Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with telaprevir combination treatment. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive telaprevir combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, telaprevir, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.

Storage

Oral

25°C (may be exposed to 15–30°C).1

Keep bottle tightly closed; use within 28 days of opening bottle.1

• Importance of using telaprevir in conjunction with peginterferon and ribavirin; not for monotherapy.1

• Importance of taking each telaprevir dose within 30 minutes after eating food that contains approximately 20 grams of fat (e.g., bagel with cream cheese, half-cup nuts, 3 tablespoons peanut butter, 1 cup ice cream, 2 ounces American or cheddar cheese, 2 ounces potato chips, half-cup trail mix).1

• If a missed telaprevir dose is remembered within 4 hours of the scheduled time, advise patient to take the missed dose with food and then resume normal dosing schedule.1 If missed dose is remembered more than 4 hours after the originally scheduled time, advise patient to skip the missed dose.1

• Possibility of serious, potentially fatal, skin reactions that may require hospitalization.1 Patients should report any skin changes or symptoms (e.g., rash with or without itching, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, facial swelling, fever) to their health-care provider who will decide whether telaprevir should be discontinued.1 (See Dermatologic Reactions under Cautions.)

• Importance of maintaining adequate hydration during treatment; inform patient of signs and symptoms of dehydration.1 Importance of contacting health-care provider in the event of poor fluid intake or severe vomiting and/or diarrhea.1

• Effect of HCV treatment on transmission of HCV unknown; patients should take appropriate precautions to prevent transmission.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise men and women of importance of using effective contraception during and for 6 months after ribavirin therapy.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

• Importance of informing patients of other important precautionary information. (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In the U.S.

• Incivek

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Protease Inhibitor

It is very important that your doctor check your progress at regular visits to make sure telaprevir is working properly. Blood tests may be needed to check for unwanted effects.

Using telaprevir together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

To make sure you are not pregnant, your doctor may ask you to have a pregnancy test before you start using telaprevir. You must have a negative pregnancy test before you will be allowed to use telaprevir with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using telaprevir, and for 6 months after your treatment ends.

Do not use the following medicines while you are using telaprevir: alfuzosin (Uroxatral®), cisapride (Propulsid®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), St. John's wort, tadalafil (Adcirca®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, Zocor®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using telaprevir with any of these medicines can cause very serious medical problems.

Serious skin reactions can occur with telaprevir. Check with your doctor right away if you have a severe skin rash, blistering, peeling, or loosening of the skin, fever or chills, hives or welts, red skin lesions, acne, sores or ulcers on the skin, or yellowing of the skin or the whites of your eyes.

Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty with breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.

Birth control pills may not work while you are using telaprevir. To keep from getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Using telaprevir with peginterferon alfa can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not change or suddenly stop using telaprevir without checking first with your doctor.

telaprevir will not keep you from giving hepatitis C to other people. Follow your doctor's instructions about how to prevent the spread of this infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Tell all of your health care providers that you take telaprevir. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Do not take St John's wort with this medicine. This medicine may not work as well.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use 2 kinds of birth control that you can trust while using telaprevir and for 6 months after stopping this medicine.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 6 months after care ends. Use birth control that you can trust.
• Do not use a hormone-related kind of birth control.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about telaprevir, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 telaprevir. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using telaprevir.

Review Date: October 4, 2017

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Incivek: 375 mg [DSC] [contains fd&c blue #2 (indigotine), fd&c red #40]

• Incivek [DSC]

Take with a meal (not low fat).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, bad taste, itching, nausea, vomiting, diarrhea, or anal irritation. Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, nausea, or vomiting), shortness of breath, loss of strength and energy, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Commonly reported side effects of telaprevir include: anemia, decreased hemoglobin, and skin rash. Other side effects include: ulcer, and bulla. See below for a comprehensive list of adverse effects.