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BRILINTA™ (ticagrelor) tablets

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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WARNINGS  top of page

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

(DESCRIPTION) top of page

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: top of page

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  top of page

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 top of page

CONTRAINDICATIONS
  • History of intracranial hemorrhage
  • Active pathological bleeding
  • Severe hepatic impairment

PRECAUTIONS top of page

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 top of page

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  top of page

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 top of page

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

© AstraZeneca 2011
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