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
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NON‒CABG-RELATED BLEEDING RATESa | BRILINTA 90 MG + ASPIRIN (n=9235) % (n) PATIENTS WITH EVENT | CLOPIDOGREL + ASPIRIN (n=9186) % (n) PATIENTS WITH EVENT |
---|---|---|
PLATO MAJOR + MINOR | 7.7 (713) | 6.2 (567) |
MAJOR | 3.9 (362) | 3.3 (306) |
FATAL/LIFE-THREATENING | 1.9 (171) | 1.6 (151) |
FATAL | 0.2 (15) | 0.2 (16) |
INTRACRANIAL HEMORRHAGE (FATAL/LIFE-THREATENING) |
0.3 (26) | 0.2 (15) |
CABG-related bleeding ratesa | BRILINTA 90 mg + aspirin (n=770) n (%) patients with event | Clopidogrel + aspirin (n=814) n (%) patients with event |
---|---|---|
PLATO total major | 626 (81.3) | 666 (81.8) |
Fatal/life-threatening | 337 (43.8) | 350 (43.0) |
Fatal | 6 (0.8) | 7 (0.9) |
BRILINTA 90 mg + aspirin | Clopidogrel + aspirin | HR | 95% CI | |
---|---|---|---|---|
NSTEMI | 5.1 | 4.4 | 1.17 | 0.94-1.45 |
STEMI | 4.0 | 3.3 | 1.17 | 0.91-1.51 |
UA | 3.9 | 3.2 | 1.29 | 0.85-1.95 |
See additional information for dyspnea and other adverse reactions.
BRILINTA 90 mg + aspirin | Clopidogrel + aspirin | |
---|---|---|
12 months* | 4.43 | 3.85 |
24 months† | 5.5 | 5.2 |
*The 12-month bleeding outcome estimate was based on the assumption of similar proportions of event rates for years 1 and 2.
†Adjusted HR: 1.20 (95% CI: 1.04-1.40).
Bleeding was defined by the patient receiving treatment for at least 1 of the following: hemorrhagic stroke, gastrointestinal bleeding, anemia-related bleeding, or other bleeding.4
BRILINTA 60 mg + aspirin (N=6958) | Placebo + aspirin (N=6996) | |
---|---|---|
EVENTS/1000 PATIENT-YEARS![]() |
EVENTS/1000 PATIENT-YEARS![]() |
|
TIMI MAJOR‡ | 8 |
3 |
FATAL§ | 1 |
1 |
INTRACRANIAL HEMORRHAGE | 2 |
1 |
TIMI MAJOR OR MINOR// | 11 |
5 |
‡TIMI major: fatal bleeding or any intracranial bleeding or clinically overt signs of hemorrhage associated with a drop in Hb of ≥5 g/dL or a fall in Hct of ≥15%.
§Fatal: a bleeding event that directly led to death within 7 days.
//TIMI minor: clinically apparent with 3-5 g/dL decrease in Hb.
See additional information for dyspnea and other adverse reactions.
Instructions for Indication and Dosing: Each asset must contain the ACS/Prior MI indication. Assets may also contain either the CAD or stroke indication (or both). Assets cannot contain just the stroke or CAD indication(s). Each asset must contain the ACS/Prior MI dosing and the corresponding dosing for CAD/Stroke if those indications are included in the asset.
BRILINTA is indicated to reduce the risk 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 risk of stent thrombosis in patients who have been stented for treatment of ACS.
BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.
BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale ≤5) or high-risk transient ischemic attack (TIA).
In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily.
In patients with CAD but no prior stroke or MI, administer 60 mg twice daily.
In patients with acute ischemic stroke or high-risk TIA, initiate treatment with a 180-mg loading dose of BRILINTA and then continue with 90 mg twice daily for up to 30 days. The treatment effect accrued early in the course of therapy. Use BRILINTA with a loading dose of aspirin (300 to 325 mg)
Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.
Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix. 3. Sahlén A, Varenhorst C, Lagerqvist B, et al. Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J. 2016;37(44):3335-3342. 4. Bonaca MP, Bhatt DL, Cohen M, et al, for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372(19):1791-1800. 5. Steg PG, Bhatt DL, Simon T, et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019;381(14):1309-1320.
References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix. 3. Sahlén A, Varenhorst C, Lagerqvist B, et al. Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J. 2016;37(44):3335-3342. 4. Bonaca MP, Bhatt DL, Cohen M, et al, for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372(19):1791-1800.
References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Steg PG, Bhatt DL, Simon T, et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019;381(14):1309-1320. 3. Fingertip Formulary.® July 11, 2020.
ACS=acute coronary syndrome; CV=cardiovascular; MI=myocardial infarction; PEGASUS=Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin; PLATO=PLATelet inhibition and patient Outcomes; SWEDEHEART=Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies; THEMIS=Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study; T2D=type 2 diabetes.
ACS=acute coronary syndrome; CV=cardiovascular; MI=myocardial infarction; PEGASUS=Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin; PLATO=PLATelet inhibition and patient Outcomes; SWEDEHEART=Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies.
ACS=acute coronary syndrome; ARR=absolute risk reduction; ARI=absolute risk increase; CABG=coronary artery bypass graft; CI=confidence interval; Hb=hemoglobin; Hct=hematocrit; HR= hazard ratio; K-M=Kaplan-Meier; PLATO=PLATelet inhibition and patient Outcomes; RRR=relative risk reduction.