Brilinta tablet/black box warning

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Brilinta tablet®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
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IV Compatibility
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
See full prescribing information for complete Boxed Warning.
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 75-100 mg per day.