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BRILINTA® (ticagrelor) Tablets
WARNING: (A) BLEEDING RISK and (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
See full prescribing information for complete boxed warning
A. BLEEDING RISK
• BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal
bleeding [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
• Do not use BRILINTA in patients with active pathological bleeding or a history of
intracranial hemorrhage [see CONTRAINDICATIONS].
• 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 [see WARNINGS AND PRECAUTIONS].
• Suspect bleeding in any patient who is hypotensive and has recently undergone coronary
angiography, percutaneous coronary intervention (PCI), CABG, or other surgery [see
WARNINGS AND PRECAUTIONS].
• If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA
increases the risk of subsequent cardiovascular events [see WARNINGS AND
PRECAUTIONS].
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
• Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and
should be avoided [see WARNINGS AND PRECAUTIONS and CLINICAL STUDIES (14) in
full Prescribing Information].
BRIEF SUMMARY of PRESCRIBING INFORMATION:
For full Prescribing Information, see package insert.
INDICATIONS AND USAGE
Acute Coronary Syndromes
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 endpoint of cardiovascular death, myocardial infarction 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 [see Clinical
Studies (14) in full Prescribing Information]. 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 [see Warnings and Precautions and Clinical
Studies (14) in full Prescribing Information].
DOSAGE AND ADMINISTRATION
Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment
with 90 mg twice daily. After the initial loading dose of aspirin (usually 325 mg), use BRI Ĕ