Patients also took other medications commonly prescribed after a heart attack.
*BRILINTA 180 mg initial dose given, followed by 90 mg twice daily.
†Plavix 300 mg to 600 mg initial dose given, followed by 75 mg once daily.
At the end of the 1-year study, BRILINTA 90 mg + aspirin was proven to work better than Plavix + aspirin by helping to protect more patients from having a heart attack or stroke or dying from a cardiovascular event.
Based on the results of this major clinical study, the FDA determined that BRILINTA 90 mg is superior to Plavix for at least the first 12 months following ACS.
BRILINTA 90 mg + Aspirin: 864 of 9,333 patients had a heart attack or stroke or died from a cardiovascular event
Plavix + Aspirin: 1,014 of 9,291 patients had a heart attack or stroke 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% (362/9,235) experienced bleeding‡ that was serious or sometimes fatal, compared to 3.3% (306/9,186) 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.
BRILINTA is used to lower your chance of having, 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. In most cases, 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, shortness of breath, and irregular breathing. Call your doctor if you have new or unexpected shortness of breath or irregular breathing, or any side effect that bothers you or 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. Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while being treated with BRILINTA.
Please read Medication Guide and Prescribing Information, including Boxed WARNINGS, for BRILINTA.
You may report side effects related to AstraZeneca products .
