What is the most important information I should know about BRILINTA?
BRILINTA is used to lower your chance of having a 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. 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. 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 treat people who:
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. These can be fatal.
Platelets are blood cells that help with normal blood clotting. BRILINTA helps prevent platelets from sticking together and forming a clot that can block an artery.
It is not known if BRILINTA is safe and effective in children.
Who should not take BRILINTA?
Do not take BRILINTA if you:
What should I tell my doctor before taking BRILINTA?
Before you take BRILINTA, tell your doctor 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?
If you are unable to swallow the tablet(s) whole, you may crush the BRILINTA tablet(s) and mix it with water. Drink all the water right away. Refill the glass with water, stir, and drink all the water.
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. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products by clicking here.
How should I store BRILINTA?
Keep BRILINTA and all medicines out of the reach of children.
General information about 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:
Inactive ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. 60 mg tablets:
Inactive ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black and ferric oxide red.
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.