BRILINTA is a medication for people who have had a heart attack. BRILINTA has been proven to significantly lower the risk of having another heart attack, stroke, or dying from a cardiovascular event.
BRILINTA was put to the test in 2 major clinical trials which studied nearly 40,000 people who had a heart attack.
Proven Effective 1 Year After a Heart Attack
People who were hospitalized for a heart attack or severe chest pain, also known as acute coronary syndrome (ACS), were studied for up to 1 year.
BRILINTA 90 mg + Aspirin was compared to Plavix® (clopidogrel bisulfate) 75 mg + Aspirin. Patients also took other medications commonly prescribed after a heart attack.
BRILINTA 90 mg twice daily + Aspirin once daily
BRILINTA 180 mg initial dose given, followed by 90 mg twice daily
Plavix 75 mg daily + Aspirin once daily
Plavix 300 mg to 600 mg initial dose given, followed by 75 mg daily
At the end of the 1-year trial,
by helping to protect more people from having heart attacks, strokes, or dying from a cardiovascular event.
Based on the results of this trial, the FDA determined that BRILINTA 90 mg is superior to Plavix for at least the first 12 months following ACS.
150 fewer people had heart attacks or strokes or died from a cardiovascular event when taking BRILINTA vs Plavix
864 of 9333 people had heart attacks or strokes or died from a cardiovascular event.
1014 of 9291 people had heart attacks or strokes or died from a cardiovascular event.
More people treated with BRILINTA experienced bleeding compared to those treated with Plavix. Of people given BRILINTA 90 mg + aspirin, 3.9% (362/9235) experienced bleeding* that was serious or sometimes fatal, compared to 3.3% (306/9186) of people given Plavix + aspirin.
* Bleeding in the brain, bleeding around the heart, bleeding resulting in a severe decrease in blood pressure requiring medical intervention, bleeding that was significantly disabling, bleeding requiring 2 or more units of blood transfusion, and bleeding that resulted in death.
Proven Effective Beyond 1 Year After a Heart Attack
People who had previously had a heart attack (1 to 3 years prior to the start of the study) were studied for up to 4 years. They were considered to be at higher risk for another heart attack based on their age and other risk factors.†
BRILINTA 60 mg + Aspirin was compared to Aspirin alone. Patients also took other medications commonly prescribed after a heart attack.
BRILINTA 60 mg twice daily + Aspirin once daily
Aspirin Alone once daily
†People included in the study were age 50 and over and had at least 1 additional risk factor (reduced kidney function, diabetes, disease in more than 1 blood vessel in the heart, age 65 or over, or had more than 1 prior heart attack).
91 fewer people had heart attacks or strokes or died from a cardiovascular event when taking BRILINTA + aspirin vs. aspirin alone.
487 of 7045 people had heart attacks or strokes or died from a cardiovascular event.
578 of 7067 people had heart attacks or strokes or died from a cardiovascular event.
More people treated with BRILINTA + aspirin experienced bleeding compared to those treated with aspirin alone. Of people taking BRILINTA 60 mg + aspirin, 1.7% (115/6958) experienced bleeding‡ that was serious or sometimes fatal, compared to 0.8% (54/6996) of people taking aspirin alone.
‡Bleeding in the brain, blood loss resulting in a significant decrease in blood volume, and bleeding that resulted in death.
American College of Cardiology
American Heart Association
2016 Treatment Guidelines for people who have had a heart attack from the American College of Cardiology (ACC) and American Heart Association (AHA) recommend BRILINTA over Plavix.
These guidelines also recommend that prescription oral antiplatelet medications, like BRILINTA, in addition to low-dose aspirin, be taken for at least the first 12 months after a heart attack.
Platelets can stick together to form a clot in your artery. And that can cause another heart attack.
BRILINTA is an oral antiplatelet medicine. It helps stop platelets from forming a new and dangerous clot that could cause another heart attack.For illustration purpose only.
BRILINTA is not the same as aspirin. They both help keep platelets from sticking together and forming a clot. But they work in different ways, so it’s important to take them both.
Do not stop taking BRILINTA without talking to the doctor who prescribes it for you.
Take BRILINTA with aspirin correctly.
Tell all of your doctors and dentists that you are taking BRILINTA. They should talk to the doctor who prescribed BRILINTA for you before you have any surgery or invasive procedure.
Ask your doctor or pharmacist if you are not sure if your medicine is listed above. Know the medicines you take and keep a list of them to show your doctor and pharmacist when you get a new medicine.
You may still have questions about your heart attack or severe chest pain. Below are some questions you, or someone you care about, may want to ask your doctor. Print these questions and bring them to your next doctor appointment.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Find out how much you will spend on your BRILINTA prescriptions with the co-pay calculator.
Do not take BRILINTA if you have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in BRILINTA. Slow heart rhythm has been reported with BRILINTA.
Take BRILINTA plus 81-mg aspirin for as long and exactly as your doctor prescribed.
Here Is a Reminder About How And When To Take Your Medicine
Another Helpful Tip
Our Medication Planner may help you remember when to take your medicines. Download the Medication Planner Now
Tips to help you remember to take your medicines:
BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.
Call your doctor right away if you have any signs or symptoms of bleeding while taking BRILINTA, including: severe, uncontrollable bleeding; pink, red, or brown urine; vomit that is bloody or looks like coffee grounds; red or black stool; or if you cough up blood or blood clots.
Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Tell all your doctors and dentists that you are taking BRILINTA. To decrease your risk of bleeding, your doctor may instruct you to stop taking BRILINTA 5 days before you have surgery. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.
Take BRILINTA and aspirin exactly as instructed by your doctor. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Tell your doctor if you take other medicines that contain aspirin. Do not take new medicines that contain aspirin.
Do not take BRILINTA if you have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in BRILINTA.
Slow heart rhythm has been reported with BRILINTA.
BRILINTA can cause serious side effects, including bleeding and shortness of breath. Call your doctor if you have new or unexpected shortness of breath or any side effect that bothers you or that does not go away. Your doctor can decide what treatment is needed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRILINTA may affect the way other medicines work, and other medicines may affect how BRILINTA works.
BRILINTA is a prescription medicine for people who have had a heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen.
BRILINTA is used with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clots in your stent if you received one. These can be fatal.