In the treatment of
ACUTE CORONARY SYNDROME
IMPROVING
CV MORTALITY
STARTS
HERE
BRILINTA CAN HELP
Proven to save more lives than clopidogrel by
reducing cardiovascular (CV) death at 12 months
CV death secondary end point: relative risk reduction (RRR) with
BRILINTA plus aspirin was 21% (absolute risk reduction [ARR] 1.1%)
vs clopidogrel plus aspirin1*
AT 12 MONTHS, BRILINTA PLUS ASPIRIN SIGNIFICANTLY REDUCED THE PRIMARY COMPOSITE END POINT of CV death,
myocardial infarction (MI),† or stroke by 16% RRR (ARR 1.9%) vs clopidogrel plus aspirin.
The difference between treatments was driven by CV death and MI with no difference in stroke.1*
BLEEDING AT 12 MONTHS, there was no significant difference in Total Major Bleeding (which includes Fatal and Life-threatening
bleeding) for BRILINTA plus aspirin vs clopidogrel plus aspirin (11.6% vs 11.2%). There was a somewhat greater risk of Non–coronary
artery bypass graft surgery (CABG)-related Major plus Minor Bleeding for BRILINTA plus aspirin vs clopidogrel plus aspirin (8.7% vs
7.0%) and Non–CABG-related Major Bleeding (4.5% vs 3.8%), respectively. The PLATelet inhibition and patient Outcomes (PLATO)
trial did not show an advantage for BRILINTA compared with clopidogrel for CABG-related Bleeding (Total Major 85.8% vs 86.9% and
Fatal/Life-threatening 48.1% vs 47.9%, respectively). When antiplatelet therapy was stopped 5 days before CABG, Major Bleeding
occurred in 75% of patients treated with BRILINTA and 79% of patients on clopidogrel.1‡
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.
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND
BRILINTA EFFECTIVENESS
A. 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
B. 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
(eg, 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