Ticagrelor (patient information)

IMPORTANT WARNING

Ticagrelor may cause serious or life-threatening bleeding. Tell your doctor if you currently have or have had a condition that causes you to bleed more easily than normal, if you have recently had surgery or been injured in any way, or if you have or have ever had a stomach ulcer; bleeding in your stomach, intestines, or head; a stroke or mini-stroke; a condition that may cause bleeding in your intestines such as polyps (abnormal growths in the lining of the large intestine); or liver disease. Tell your doctor and pharmacist if you are taking medications that may cause bleeding including anticoagulants (blood thinners) such as warfarin (Coumadin); heparin; other medications to treat or prevent blood clots; or regular use of non-steroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Your doctor also will probably not prescribe ticagrelor if you are likely to need heart bypass surgery (a certain type of open heart surgery) right away. While you are taking ticagrelor, you will probably bruise and bleed more easily than usual or bleed for longer than usual and may be more likely to have nosebleeds. However, if you experience any of the following symptoms, call your doctor immediately: bleeding that is unexplained, severe, long-lasting, or uncontrollable; pink or brown urine; red or black, tarry stools; vomit that is bloody or that looks like coffee grounds; or coughing up blood or blood clots.

If you are having surgery, including dental surgery, or any type of medical procedure, tell your doctor or dentist that you are taking ticagrelor. Your doctor will probably tell you to stop taking ticagrelor at least 5 days before your surgery is scheduled.

Your doctor will probably tell you to take a low dose of aspirin (less than 100 mg) during your treatment, but taking higher doses of aspirin may prevent ticagrelor from working as it should. Many over-the-counter (OTC) medications contain aspirin, so be sure to read all labels carefully. Do not take additional aspirin or aspirin-containing products during your treatment with ticagrelor without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ticagrelor and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking ticagrelor.

Why this medication is prescribed?

Ticagrelor is used along with aspirin to prevent serious problems with the heart and blood vessels in people who have had a heart attack or severe chest pain. Ticagrelor is in a class of medications called antiplatelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.

How this medication should be used?

Ticagrelor comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take ticagrelor at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ticagrelor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ticagrelor will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Continue to take ticagrelor even if you feel well. Do not stop taking ticagrelor without talking to your doctor. If you stop taking ticagrelor, there is a higher risk that you may have a heart attack or stroke. If you have a stent (small tube placed in an artery to improve blood flow), there is also a higher risk that you could develop a blood clot in the stent if you stop taking ticagrelor too soon.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking ticagrelor, tell your doctor and pharmacist if you are allergic to ticagrelor, any other medications, or any of the ingredients in ticagrelor tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: certain antibiotics such as clarithromycin (Biaxin, in PrevPak) and telithromycin (Ketek); antifungal medications such as itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), and voriconazole (Vfend); certain cholesterol-lowering medications such as lovastatin (Mevacor, Altoprev) and simvastatin (Zocor, in Vytorin); dexamethasone; digoxin (Lanoxin); medications for high blood pressure; medications for human immunodeficiency virus (HIV) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Tegretol, Equetro), phenobarbital, and phenytoin (Dilantin); nefazodone; and rifampin (Rifadin, Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had any type of lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) or asthma. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ticagrelor, call your doctor.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Ticagrelor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Headache

Back pain

Cough

Dizziness

Nausea

Diarrhea

Tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately: shortness of breath

Chest pain

Fast, slow, pounding, or irregular heartbeat

Ticagrelor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

Bleeding

Nausea

Vomiting

Diarrhea

Irregular heartbeat

Other information

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ticagrelor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

Brilinta^®

Patient counselling information from FDA

Benefits and Risks

Tell patients to take BRILINTA exactly as prescribed.

Inform patients not to discontinue BRILINTA without discussing it with the prescribing physician.

Tell patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin.

Tell patients to read the Medication Guide.

Bleeding

Inform patients that they:

Will bleed and bruise more easily

Will take longer than usual to stop bleeding

Should report any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine.

Other Signs and Symptoms Requiring Medical Attention

Inform patients that BRILINTA can cause shortness of breath. Tell them to contact their doctor if they experience unexpected shortness of breath, especially if severe.

Invasive Procedures

Instruct patients to:

Inform physicians and dentists that they are taking BRILINTA before any surgery or dental procedure.

Tell the doctor performing any surgery or dental procedure to talk to the prescribing physician before stopping BRILINTA.

Concomitant Medications

Tell patients to list all prescription medications, over-the-counter medications or dietary supplements they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g. warfarin, heparin).

Issued: 12/2013

BRILINTA® is a trademark of the AstraZeneca group of companies.

Distributed by: AstraZeneca LP, Wilmington, DE 19850

Catogary: Drugs