In PLATO*, 46% of patients in both groups received clopidogrel in hospital prior to randomization.
All patients randomized to BRILINTA received a loading dose of 180 mg1,2
Begin maintenance dose 12 hours after loading dose3
In PEGASUS†, patients could be randomized regardless of their prior
adenosine diphosphate receptor blocker therapy or a lapse in therapy1
BRILINTA can be administered with or without food1
A patient who misses a dose of BRILINTA should take one tablet (the next dose) at its scheduled time1
BRILINTA is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Avoid use of BRILINTA in patients with severe hepatic impairment. There is limited experience with BRILINTA in patients with moderate hepatic impairment; consider risks and benefits of treatment. No dosage adjustment is needed in patients with mild hepatic impairment1
No dosage adjustment is needed in patients with renal impairment. Patients on dialysis have not been studied.1
View drug interactions for BRILINTA.
IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor) 60-MG AND 90-MG TABLETS
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
*The PLATO study compared BRILINTA (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter) for the prevention of thrombotic CV events (CV death, MI, or stroke) in 18,624 patients with ACS (UA, NSTEMI, STEMI). Patients were treated for at least 6 months and up to 12 months. Patients were excluded if they had a previous intracranial hemorrhage, gastrointestinal bleeding within 6 months, had a known bleeding diathesis or coagulation disorder, or required treatment with anticoagulants. BRILINTA and clopidogrel were studied with aspirin and other standard therapies.
†The PEGASUS-TIMI 54 trial compared BRILINTA (90 mg twice daily or 60 mg twice daily) vs placebo, each given with low-dose aspirin, for the prevention of thrombotic CV events (CV death, MI, or stroke) in 21,162 patients ≥50 years of age with a history of MI
(1 to 3 years prior to randomization) and at least 1 risk factor for thrombotic CV events. Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months. Patients were excluded if they required renal dialysis, had a previous intracranial hemorrhage, had gastrointestinal bleeding within 6 months, had a known bleeding diathesis or coagulation disorder, or required treatment with anticoagulants. Only the 60-mg dose strength is approved for use in patients with a history of MI 1 year after an ACS event.
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.