Brilinta Generic Name: ticagrelor

Brilinta

Generic Name: ticagrelor
Date of Approval: July 20, 2011
Company: AstraZeneca

Treatment for: Acute Coronary Syndrome

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.

What is Brilinta?

Brilinta is a prescription medicine used to treat people who:

• have had a recent heart attack or severe chest pain that happened because their heart was not getting enough oxygen.
• have had a heart attack or chest pain and are being treated with medicines or with a procedure to open blocked arteries in the heart.

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 works in children.

Who should not take Brilinta?

Do not take Brilinta if you:

• are bleeding now
• have a history of bleeding in the brain
• have bleeding from your stomach or intestine now (an ulcer)
• have severe liver problems

When instructed by your doctor, you should stop taking Brilinta five 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.

Before taking Brilinta

Before you take Brilinta, tell your doctor if you:

• have had bleeding problems in the past
• have had any recent serious injury or surgery
• plan to have surgery or a dental procedure
• have a history of stomach ulcers or colon polyps
• have lung problems, such as COPD or asthma
• have liver problems
• have a history of stroke
• are pregnant, or are plan to become pregnant. It is not known if Brilinta will harm your unborn baby. You and your doctor should decide if you will take Brilinta.
• are breastfeeding. It is not known if Brilinta passes into your breast-milk. You and your doctor should decide if you will take Brilinta or breastfeed. You should not do both without talking with your doctor.

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 non-prescription 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:

• an HIV-AIDS medicine
• medicine for heart conditions or high blood pressure
• medicine for high blood cholesterol levels
• an anti-fungal medicine by mouth
• an anti-seizure medicine
• a blood thinner medicine
• rifampin (Rifater, Rifamate, Rimactane, Rifadin)

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?

• Take Brilinta exactly as prescribed by your doctor.
• Your doctor will tell you how many Brilinta tablets to take and when to take them.
• Take Brilinta with a low dose (not more than 100 mg daily) of aspirin. You may take Brilinta with or without food.
• Take your doses of Brilinta around the same time every day.
• If you forget to take your scheduled dose of Brilinta, take your next dose at its scheduled time. Do not take two doses at the same time unless your doctor tells you to.
• If you take too much Brilinta or overdose, call your doctor or poison control center right away, or go to the nearest emergency room.

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.