BRILINTA™ (ticagrelor) Tablets

Warnings

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Clinical pharmacology

Indications and usage

Contraindications

Precautions

Adverse reactions

Dosage and administration

How supplied

Reference

Warnings

WARNING: 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

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVNESS

Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75-100 mg per day

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BRILINTA safely and effectively. See full prescribing information for BRILINTA.

BRILINTA™ (ticagrelor) tablets, for oral use
Initial U.S. Approval: 2011

BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor.

Clinical pharmacology

Mechanism of Action
Ticagrelor and its major metabolite reversibly interact with the platelet P2Y12 ADP-receptor to prevent signal transduction and platelet activation. Ticagrelor and its active metabolite are approximately equipotent.

Indications and usage

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.

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

Contraindications

CONTRAINDICATIONS

History of intracranial hemorrhage
Active pathological bleeding
Severe hepatic impairment

Precautions

WARNINGS AND PRECAUTIONS:

Like other antiplatelet agents, BRILINTA increases the risk of bleeding.
In PLATO, use of BRILINTA with maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA.
Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
Dyspnea: Dyspnea was reported more frequently with BRILINTA than with clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes.
Discontinuation of BRILINTA: Premature discontinuation increases the risk of myocardial infarction, stent thrombosis, and death.

Adverse reactions

ADVERSE REACTIONS

Most common adverse reactions are bleeding 12% and dyspnea 14%.

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Dosage and administration

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 BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.

BRILINTA can be administered with or without food.

A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.

How supplied

HOW SUPPLIED/STORAGE AND HANDLING

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet marked with a “90” above “T” on one side.

Bottles of 60 – NDC 0186-0777-60

Bottles of 180 – NDC 0186-0777-18

100 count Hospital Unit Dose – NDC 0186-0777-39

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP controlled room temperature].

Keep BRILINTA in the container it comes in.

Keep BRILINTA tablets dry.

Reference

Package Insert data:

Issued: 07/2011

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by: AstraZeneca LP, Wilmington, DE 19850

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.