Incivek: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Adult patients with chronic hepatitis C who have either not

received previous treatment or who failed prior treatment with peginterferon alfa or peginterferon alfa and ribavirin.

INCIVEK must not be taken by itself to treat chronic hepatitis C. INCIVEK must be used in combination with two other medications (peginterferon alfa and ribavirin) to treat chronic hepatitis C. It is important that you also read and follow the CONSUMER INFORMATION for the other medications because they have additional important information about your treatment that is not covered in this CONSUMER INFORMATION leaflet. You should receive and read the CONSUMER INFORMATION each time you fill or refill prescriptions for those medications.

INCIVEK is sometimes called INCIVEK combination treatment because it is always used in combination with two other medications.

INCIVEK is taken for 12 weeks as part of the combination treatment; the other two medications are taken for a longer period of time. Your doctor will tell you how long to take the other 2 medications.

What it does:

INCIVEK is a prescription medicine. It treats a disease in adults called chronic hepatitis C (chronic means lasting a long time). The hepatitis C virus infects the liver and is also present in the blood. INCIVEK does not work by itself. It is always used in combination with peginterferon alfa and ribavirin.

When it should not be used:

Do not take INCIVEK if you:

• Are allergic to any of the ingredients in INCIVEK (see What the non-medicinal ingredients are).

• Are pregnant or planning to become pregnant while on INCIVEK combination treatment or during the six (6) months after treatment ends. Talk to your doctor if you are pregnant or plan to become pregnant.

• Are a man with a sexual partner who is pregnant or may become pregnant at any time while you are being treated with INCIVEK combination treatment, or during the six

  • (6) months after your combination treatment ends.
  • Are taking any of the medicines listed under “Do not take INCIVEK with any of the medicines below” in the INTERACTIONS WITH THIS MEDICATION section.

What the medicinal ingredient is:

telaprevir

What the non-medicinal ingredients are:

Colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 40, dibasic calcium phosphate (anhydrous), FD&C Blue No. 2, hypromellose acetate succinate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide

What dosage forms it comes in:

Each INCIVEK tablet contains 375 mg of telaprevir.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Contact your doctor immediately if you develop symptoms of a serious skin reaction (see Serious Warnings and Precautions box) such as:

• blisters or skin lesions
• swelling of your face
• mouth sores or ulcers
• rash, with or without itching
• red or inflamed eyes like “pink eye” (conjunctivitis)
• fever

INCIVEK must be taken in combination with both peginterferon alfa and ribavirin. The co-administered drug, ribavirin, may cause birth defects and death of the fetus. Extreme care must be taken to avoid pregnancy.

Tell your doctor immediately if you or your partner become pregnant while on INCIVEK combination treatment or during the six (6) months after treatment ends.

Birth control pills, birth control patches or other forms of birth control that contain hormones may not work to prevent pregnancy while you are taking INCIVEK.

You must use at least two (2) forms of birth control when you take INCIVEK combination treatment and for the six (6) months after treatment. If you use birth control that contains hormones, you must use two (2) other forms of birth control and continue to do so for at least two (2) months after you finish taking INCIVEK.

Talk to your doctor about what type of birth control is best for you while taking INCIVEK combination treatment.

Do not breastfeed your baby while taking INCIVEK. It is not known whether INCIVEK passes into human breast milk.

BEFORE you use INCIVEK talk to your doctor about your medical history. Tell your doctor if you have any of the following:

• Received a treatment for hepatitis C that did not work
• Liver problems (other than hepatitis C infection)
• Hepatitis B infection
• Blood problems
• HIV (Human Immunodeficiency Virus)/AIDS or any problems with your immune system
• Kidney problems
• History of gout or high uric acid levels in the blood
• Taking medicine because of an organ transplant; or have had a recent organ transplant
• Thyroid problems
• Heart problems such as heart failure, irregular or slow heartbeat, or a condition called long QT syndrome
• Any other medical problems

Your health care professional will check your blood regularly for anemia and other possible blood problems while you are taking INCIVEK combination treatment.

Drugs that cause an effect on the electrical conduction of the heart known as QTc prolongation should be taken with caution in patients receiving INCIVEK. Tell your doctor if you take any of the following drugs that have been associated with QTc interval prolongation and/or torsade de pointes including, but not limited to, the following: quinidine, amiodarone, sotalol, flecainide, propafenone, fluoxetine, methadone, erythromycin, moxifloxacin, quinine, ketoconazole, haloperidol, vardenafil, ritonavir, or salmeterol.

Tell your health care provider about all the medicines you take including over-the-counter medicines, vitamins and herbal medicines. Keep a list of them with you and show it to your health care provider and pharmacist each time you get a new medicine. (See Interactions with this medication).

INTERACTIONS WITH THIS MEDICATION

Do not take INCIVEK with any of the medicines below. They can cause serious or life-threatening reactions with INCIVEK.

† Not currently marketed in Canada.

This is not a complete list of medicines that you should tell your doctor about. You should check with your doctor or pharmacist before taking any other drug with INCIVEK.

Other medicines that may interact with INCIVEK.

The following medicines may interact with INCIVEK. Dosage of INCIVEK or the other drug may have to be revised or other change may be required. Talk to your doctor if you are taking any of these drugs:

• alfentanil, alprazolam, amlodipine, atorvastatin, bosentan, budesonide, buspirone, clarithromycin, colchicine, cyclosporine, darunavir, dexamethasone (systemic), diazepam, digoxin, diltiazem, efavirenz, erythromycin, escitalopram, felodipine, fentanyl, fluticasone, fluvastatin, fosamprenavir, itraconazole, ketoconazole, lidocaine (systemic), lopinavir,
• methadone, midazolam (parenteral), nicardipine, nifedipine, nisoldipine, posaconazole, pravastatin, repaglinide, rifabutin, rosuvastatin, salmeterol, sildenafil (for erectile dysfunction), sirolimus, tacrolimus, tadalafil, telithromycin, trazodone, verapamil, voriconazole, warfarin, zolpidem.

PROPER USE OF THIS MEDICATION

Usual adult dose:

• Take INCIVEK exactly as your doctor tells you. Your doctor will tell you how much INCIVEK to take. Do not change the amount you take unless your doctor tells you to.
• INCIVEK is taken for twelve (12) weeks as part of the combination treatment.

• Always take your INCIVEK dose with food (not low-fat).

• Three (3) tablets of INCIVEK are taken two (2) times a day. Each dose should be taken no less than ten (10) hours apart and no more than fourteen (14) hours apart. The total dose is 6 tablets per day.
• Take INCIVEK tablets whole, with water. Do not break or crush INCIVEK tablets before you swallow them. Do not chew INCIVEK. It has a bitter taste. Tell your health care professional if you have problems swallowing whole tablets.
• Do not stop taking INCIVEK unless your doctor tells you to. If you think there is a reason to stop taking INCIVEK, talk to your doctor before doing so.
• If your doctor tells you to stop taking INCIVEK, you should not start taking it again even if the reason for stopping goes away. If INCIVEK is stopped you can not restart treatment with INCIVEK.

Overdose:

Missed Dose:

• If you miss a dose within six (6) 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 six (6) hours after the time you usually take it, skip that dose only and take the next dose at your normal dosing schedule. Do not double dose.
• If you miss more than one dose call your doctor right away.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Before you start taking INCIVEK, talk to your doctor about the possible side effects.

The common side effects of INCIVEK include:

• Rash (mild to moderate)

  • A rash can happen at any time with INCIVEK combination treatment. There may be itching with the rash. In most people who develop rash, the rash is mild or moderate and it goes away when treatment ends.
  • It is possible for any rash, even a mild rash, to get worse. Call your doctor right away if you get a rash or if you have a rash that gets worse. Your doctor will decide if you need medicine for the rash or if you need to stop taking INCIVEK or any of your other medications.
• Itching can happen with or without rash; it is common and usually goes away when treatment ends.

• Anal or rectal problems are common and may be uncomfortable. They usually go away either during or after you finish your treatment.

  • Hemorrhoids (swollen veins in the rectum or anus, the opening to the rectum)
  • Discomfort or burning around or near the anus
  • Itching around or near the anus

• INCIVEK combination treatment may cause anemia.

  • Anemia occurs when your blood does not have enough red blood cells. The red blood cells carry and deliver oxygen to your body.
  • Anemia may make you feel tired, weak, or low on energy. Anemia may also make you feel dizzy or short of breath.

Other common side effects of INCIVEK combination treatment:

• Nausea, diarrhea, vomiting and taste alteration.

Rare side effect of INCIVEK combination treatment:

• Serious skin reactions have been reported (e.g., blistering and peeling skin, ulcers, rash, and fever). If you get a serious skin reaction, stop using all products and call your doctor right away.

Tell your health professional about any side effect that bothers you or does not go away.

This is not a complete list of side effects. For any unexpected effects while taking INCIVEK, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 25°C; excursions permitted to 15-30°C.

Keep INCIVEK and all medicines out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.vrtx.ca

or by contacting the sponsor, Vertex Pharmaceuticals (Canada) Incorporated

at: 877-634-VRTX (8789)

©2013 Vertex Pharmaceuticals Incorporated

Last revised: December 17, 2013