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.

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

    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

    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
     
  • Risk factors for bleeding include older age, a history of bleeding disorders, performance of PCI, and concomitant use of medications that increase the risk of bleeding
  • If BRILINTA must be temporarily discontinued, restart it as soon as possible
  • The use of BRILINTA is also contraindicated in severe hepatic impairment. BRILINTA has not been studied in patients with moderate hepatic impairment. Consider the risks and benefits of treatment, noting the probable increase in exposure to BRILINTA
  • Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. If dyspnea is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption
  • BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers
  • Avoid simvastatin and lovastatin doses >40 mg. BRILINTA will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4
  • Monitor digoxin levels with initiation of, or any change in BRILINTA therapy, because of inhibition of the P-glycoprotein transporter
  • There is limited clinical experience in patients at increased risk of symptomatic bradycardic events. In PLATO, syncope, presyncope and loss of consciousness were reported by 1.7% and 1.5% of BRILINTA and clopidogrel patients, respectively. In a Holter substudy of about 3000 patients in PLATO, more patients had ventricular pauses with BRILINTA (6.0%) than with clopidogrel (3.5%) in the acute phase; rates were 2.2% and 1.6% respectively after one month
  • The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)

INDICATIONS

BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular 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 cardiovascular (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 above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.

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