FDA Approves Brilinta

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FDA Approves Brilinta

The U.S. Food and Drug Administration has approved
the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).

ACS includes a group of symptoms for any condition, such as unstable angina or heart attack, that could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event.

Brilinta Medication Guide

Read this Medication Guide before you start taking Brilinta and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Important information 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:
  • you may bruise and bleed more easily
  • you are more likely to have nose bleeds
  • it will take longer than usual for any bleeding to stop
Call your doctor right away, if you have any of these signs or symptoms of bleeding while taking Brilinta:
  • bleeding that is severe or that you cannot control
  • pink, red or brown urine
  • vomiting blood or your vomit looks like "coffee grounds"
  • red or black stools (looks like tar)
  • coughing 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.
When instructed by your doctor, you should stop taking Brilinta 5 days before you have elective 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.

Brilinta side effects

Brilinta can cause serious side effects, including:
  • See Important information about Brilinta
  • Shortness of breath. Call your doctor if you have new or unexpected shortness of breath when you are at rest, at night, or when you are doing any activity. Your doctor can decide what treatment is needed.
Tell your doctor if you have any side effect that bothers you or that does not go away.
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 to FDA at 1-800-FDA-1088.

How should I store Brilinta?

  • Store Brilinta at room temperature between 59°F to 86°F (15°C to 30°C).
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.
This Medication Guide summarizes the most important information about Brilinta. If you would like more information about Brilinta, talk with your doctor. You can ask your pharmacist or doctor for information about Brilinta that is written for health professionals.
For more information call 1-800-236-9933 or go to www.Brilinta.com.

What are the ingredients in Brilinta?

Active ingredient: ticagrelor
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.

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