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 90 mg plus aspirin was 21% (absolute risk reduction
[ARR] 1.1%) vs clopidogrel plus aspirin1*
AT 12 MONTHS, BRILINTA 90 mg 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 PLATO-defined Non–CABG-related Major plus Minor Bleeding for BRILINTA 90 mg plus aspirin vs clopidogrel plus aspirin
(7.7% vs 6.2%) and non–CABG-related Major Bleeding (3.9% vs 3.3%), respectively. About half of the Non-CABG-related Major bleeding
events were in the first 30 days. The PLATelet inhibition and patient Outcomes (PLATO) trial did not show an advantage for BRILINTA
90 mg compared with clopidogrel for CABG-related Bleeding (Total Major 81.3% vs 81.8% and Fatal/Life-threatening 43.8% vs 43.0%,
respectively). Rates of Major Fatal/Life-threatening CABG-related Bleeding were similar between BRILINTA 90 mg and clopidogrel when
study drug was withheld 1-5 days before CABG surgery. When antiplatelet therapy was stopped 5 days before CABG, Major Bleeding
occurred in 75% of patients treated with BRILINTA 90 mg and 79% of patients on clopidogrel.1‡
INDICATIONS
BRILINTA is indicated to reduce the rate of cardiovascular death,
myocardial infarction (MI), and stroke in patients with acute coronary
syndrome (ACS) or a history of myocardial infarction. For at least the
first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who
have been stented for treatment of ACS.
IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor)
60-MG AND 90-MG TABLETS
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 undergoing urgent coronary
artery bypass graft surgery
•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
CONTRAINDICATIONS
• BRILINTA is contraindicated in patients with a history of
intracranial hemorrhage or active pathological bleeding such
as peptic ulcer or intracranial hemorrhage. BRILINTA is also
contraindicated in patients with hypersensitivity (eg, angioedema)
to ticagrelor or any component of the product
WARNINGS AND PRECAUTIONS
• Dyspnea was reported in about 14% of patients treated with
BRILINTA, more frequently than in patients treated with control
agents. Dyspnea resulting from BRILINTA is often self-limiting
• Discontinuation of BRILINTA will increase the risk of MI, stroke,
and death. When possible, interrupt therapy with BRILINTA
for 5 days prior to surgery that has a major risk of bleeding. If
BRILINTA must be temporarily discontinued, restart as soon
as possible
• Avoid use of BRILINTA in patients with severe hepatic
impairment. Severe hepatic impairment is likely to increase
serum concentration of ticagrelor and there are no studies of
BRILINTA in these patients
ADVERSE REACTIONS
• The most common adverse reactions associated with the use
of BRILINTA included bleeding and dyspnea: In PLATO, for
BRILINTA vs clopidogrel, non-CABG PLATO-defined major
bleeding (3.9% vs 3.3%) and dyspnea (14% vs 8%); in PEGASUS,
BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs
0.8%) and dyspnea (14% vs 6%)