Welcome to the BRILINTA REMS Web site

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risk(s) associated with a drug product, and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.

In order for AstraZeneca to communicate certain risks about BRILINTA, AstraZeneca has worked with the FDA to develop materials to communicate the risks that:

• BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding
• Higher maintenance doses of aspirin (above 100 mg) decreased the efficacy of BRILINTA

If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.

The REMS is designed to communicate important information on the potential risk of bleeding and the appropriate maintenance dose of aspirin to use with BRILINTA. The BRILINTA REMS includes a Medication Guide (for patients) and a Communication Plan, including Dear Healthcare Professional Letter and Professional Organization Letter (for healthcare professionals).

To learn more about the serious risks see the Full Prescribing Information for BRILINTA.

The goals of the BRILINTA REMS are:

• To inform healthcare professionals and patients of the serious risks associated with BRILINTA, particularly the increased risk of bleeding.
• To inform healthcare professionals and patients that the daily maintenance dose of aspirin, co-administered with BRILINTA, should not exceed 100 mg.

Important Prescribing Provisions Related to the Appropriate Aspirin Dose:

Dosage and Administration:

• Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice daily
• Limit concomitant aspirin maintenance dose to 75-100 mg/day
• BRILINTA can be administered with or without food
• A patient who misses a dose of BRILINTA should take one 90 mg tablet (the next dose) at its scheduled time

Warnings and Precautions:

• BRILINTA has been studied in combination with aspirin. Higher aspirin doses (above 100 mg) decreases the efficacy of BRILINTA.

• Read the Dear Healthcare Professional Letter
• Read the Professional Society Letter

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

 

WARNING: BLEEDING RISK

• BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding
• Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
• Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery
• Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA
• If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

• Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day

CONTRAINDICATIONS

• BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins. BRILINTA is also contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product

WARNINGS AND PRECAUTIONS

• Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor
• Premature discontinuation increases the risk of MI, stent thrombosis, and death
• Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes
• BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg
• Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy

ADVERSE REACTIONS

• The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)
• In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment

INDICATIONS

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non–ST-elevation myocardial infarction, or ST-elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin >100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin >100 mg daily.

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.