Brilinta prevents platelets in your blood from sticking together to form an unwanted blood clot that could block an artery.

Brilinta is used to lower your risk of heart attack, stroke, or death due to a blocked artery or a prior heart attack.

Brilinta is also used to lower your risk of blood clots if you have coronary artery disease (decreased blood flow to the heart) and have been treated with stents to open clogged arteries.

Brilinta is also used to lower your risk of a first heart attack or stroke if you have decreased blood flow to the heart.

Brilinta is also used to lower the risk of stroke and death in adults with a blockage or decreased blood flow in an artery that supplies blood to the brain.

This medicine is usually given together with low-dose aspirin. Carefully follow your doctor's dosing instructions. Using too much aspirin can make ticagrelor less effective.

You should not use Brilinta if you have any active bleeding (including a bleeding stomach ulcer), or a history of bleeding in the brain. Do not use this medicine just before heart bypass surgery (coronary artery bypass graft, or CABG).

You may need to stop using this medicine for a short time before having surgery or dental work, to prevent excessive bleeding. Do not stop taking Brilinta without first talking to your doctor, even if you have signs of bleeding. Stopping this medicine may increase your risk of a heart attack or stroke.

Brilinta may cause you to bleed more easily, which can be severe or life-threatening. Avoid activities that may increase your risk of bleeding or injury.

Call your doctor or seek emergency medical attention if you have bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, red or pink urine, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of internal bleeding.

Many drugs (including some over-the-counter medicines and herbal products) can cause serious medical problems if you take them with Brilinta. It is very important to tell your doctor about all medicines you have recently used.

Take Brilinta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Brilinta is taken together with aspirin. Use these medicines exactly as directed.

Do not take more aspirin than your doctor has prescribed. Taking too much aspirin can make Brilinta less effective.

Take this medicine at the same time each day, with or without food.

If you cannot swallow a tablet whole, crush the pill and mix it with water. Stir and drink this mixture right away. Add more water to the glass, stir, and drink right away.

Brilinta keeps your blood from coagulating (clotting) and can make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

To prevent excessive bleeding, you may need to stop using Brilinta for a short time before a surgery, medical procedure, or dental work. Any healthcare provider who treats you should know that you are taking ticagrelor.

Do not stop taking Brilinta without first talking to your doctor, even if you have signs of bleeding. Stopping the medicine could increase your risk of a heart attack or stroke.

Ticagrelor may affect medical testing for platelets in your blood and you may have false results. Tell the laboratory staff that you use Brilinta.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Acute Coronary Syndrome:

Following an acute coronary syndrome (ACS) event:

Loading dose: 180 mg orally once
Maintenance dose: 90 mg orally twice a day for 1 year
Maintenance dose after 1 year: 60 mg orally twice a day

Comments:
-This drug should be taken in conjunction with a daily maintenance dose of aspirin 75 to 100 mg orally once a day.
-For at least the first 12 months following ACS, this drug is superior to clopidogrel.

Uses:
-To reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.
-To reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Usual Adult Dose for Prevention of Atherothrombotic Events:

Following an acute coronary syndrome (ACS) event:

Loading dose: 180 mg orally once
Maintenance dose: 90 mg orally twice a day for 1 year
Maintenance dose after 1 year: 60 mg orally twice a day

Comments:
-This drug should be taken in conjunction with a daily maintenance dose of aspirin 75 to 100 mg orally once a day.
-For at least the first 12 months following ACS, this drug is superior to clopidogrel.

Uses:
-To reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.
-To reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Usual Adult Dose for Thromboembolic Stroke Prophylaxis:

60 mg orally twice a day

Use: To reduce the risk of a first myocardial infarction (MI) or stroke in patients with coronary artery disease (CAD) at high risk for such events; while use is not limited to this setting, efficacy of this drug was established in a population with type 2 diabetes mellitus (T2DM).

Usual Adult Dose for Coronary Artery Disease:

60 mg orally twice a day

Use: To reduce the risk of a first myocardial infarction (MI) or stroke in patients with coronary artery disease (CAD) at high risk for such events; while use is not limited to this setting, efficacy of this drug was established in a population with type 2 diabetes mellitus (T2DM).

Usual Adult Dose for Myocardial Infarction -- Prophylaxis:

60 mg orally twice a day

Use: To reduce the risk of a first myocardial infarction (MI) or stroke in patients with coronary artery disease (CAD) at high risk for such events; while use is not limited to this setting, efficacy of this drug was established in a population with type 2 diabetes mellitus (T2DM).

You should not use Brilinta if you are allergic to ticagrelor, or if you have:

• any active bleeding; or

• a history of bleeding in the brain (such as from a head injury).

Tell your doctor if you have ever had:

• a stroke;

• heart problems;

• high cholesterol;

• bleeding problems;

• a stomach ulcer or colon polyps;

• liver disease; or

• kidney disease;

• asthma, COPD (chronic obstructive pulmonary disorder) or other breathing problems;

• recent surgery or serious injuries; or

• if you are planning to have surgery or a dental procedure; or

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Brilinta passes into breastmilk. Talk to your doctor before using Brilinta if you are breastfeeding.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause excessive bleeding.

Drinking alcohol while taking aspirin can increase your risk of stomach bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

While taking Brilinta with aspirin, avoid using medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as salicylates, ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much aspirin which can increase your risk of bleeding.

Get emergency medical help if you have signs of an allergic reaction to Brilinta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;

• fainting or dizzy spells;

• nosebleeds, or any bleeding that will not stop;

• shortness of breath even with mild exertion or while lying down;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• red, pink, or brown urine;

• black, bloody, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Common Brilinta side effects may include:

• bleeding; or

• shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with Brilinta, especially:

• antifungal medicine (including ketoconazole, itraconozole, voriconazole, and others);

• antibiotic medication (including clarithromycin);

• antiviral medicine to treat HIV or AIDS;

• other blood thinners;

• cholesterol medication (including simvastatin or lovastatin);

• heart or blood pressure medication;

• opioid medication;

• seizure medicine; or

• tuberculosis medicine (especially rifampin).

This list is not complete and many other drugs may affect Brilinta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.