BRILINTA Ticagrelor
Refer to the “Also Known As” section to reference different products that include the same medication as BRILINTA.
Drug Basics
Brand Name: BRILINTA
Generic Name: TICAGRELOR
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET
Packager: AstraZeneca Pharmaceuticals LP
Data Current As Of: 2021-02-11
Indications & Usage
BRILINTA is a P2Y12 platelet inhibitor indicated
- to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
- BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1)
- to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2)
- to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3)
acute coronary syndrome or a history of myocardial infarction
BRILINTA is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1)].
coronary artery disease but no prior stroke or myocardial infarction
BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2) ] . While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM).
acute ischemic stroke or transient ischemic attack (tia)
BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3) ].
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin.
Advise 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.
Advise patients to contact their doctor if they experience unexpected shortness of breath, especially if severe.
Advise patients to inform physicians and dentists that they are taking BRILINTA before any surgery or dental procedure.
Advise women that breastfeeding is not recommended during treatment with BRILINTA [see Use in Specific Populations (8.2)].
BRILINTA® is a trademark of the AstraZeneca group of companies.
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
© AstraZeneca 2020
MEDICATION GUIDE BRILINTA® (brih-LIN-tah) (ticagrelor) Tablets |
What is the most important information I should know about BRILINTA? BRILINTA is used to lower your chance of having, or dying from, a heart attack or stroke. BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery. While you take BRILINTA:
Call your doctor right away, if you have any of these signs or symptoms of bleeding while taking BRILINTA:
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. Your doctor may instruct you to stop taking BRILINTA 5 days before surgery. This will help to decrease your risk of bleeding with your surgery or procedure. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery. Taking BRILINTA with aspirin BRILINTA is taken with aspirin. Talk to your doctor about the dose of aspirin that you should take with BRILINTA. In most cases, you should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Do not take doses of aspirin higher than what your doctor tells you to take. Tell your doctor if you take other medicines that contain aspirin, and do not take new over-the-counter medicines with aspirin in them. |
What is BRILINTA? BRILINTA is a prescription medicine used to:
It is not known if BRILINTA is safe and effective in children. |
Do not take BRILINTA if you:
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Before taking BRILINTA, tell your doctor about all of your medical conditions, if you:
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. 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. Especially tell your doctor if you take:
Ask your doctor or pharmacist if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. |
How should I take BRILINTA?
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What are the possible side effects of BRILINTA? BRILINTA can cause serious side effects, including:
These are not all of the possible side effects of BRILINTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store BRILINTA?
Keep BRILINTA and all medicines out of the reach of children. |
General information about the safe and effective use of BRILINTA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRILINTA for a condition for which it was not prescribed. Do not give BRILINTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about BRILINTA that is written for health professionals. |
What are the ingredients in BRILINTA? Active ingredient: ticagrelor. 90 mg tablets: 60 mg tablets: Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 For more information call 1-800-236-9933 or go to www.Brilinta.com. |
- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2020
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