Ticagrelor
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
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Black Box Warning
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WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS
See full prescribing information for complete Boxed 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 surgery. If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
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Overview
Ticagrelor is a P2Y12 platelet inhibitor, Platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of acute coronary syndromes (ACS) (unstbale angina), non-ST elevation myocardial infarction, or ST elevation myocardial infarction).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Major and minor bleeding, headache, elevated serum creatinine, cough and dyspnea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ticagrelor FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Ticagrelor Contraindications in the drug label.
Warnings
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WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS
See full prescribing information for complete Boxed 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 surgery. If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
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There is limited information regarding Ticagrelor Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ticagrelor Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ticagrelor Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ticagrelor Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ticagrelor in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ticagrelor in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ticagrelor during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ticagrelor in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ticagrelor in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ticagrelor in geriatric settings.
Gender
There is no FDA guidance on the use of Ticagrelor with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ticagrelor with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ticagrelor in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ticagrelor in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ticagrelor in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ticagrelor in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ticagrelor Administration in the drug label.
Monitoring
There is limited information regarding Ticagrelor Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ticagrelor and IV administrations.
Overdosage
There is limited information regarding Ticagrelor overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ticagrelor Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ticagrelor Mechanism of Action in the drug label.
Structure
There is limited information regarding Ticagrelor Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ticagrelor Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ticagrelor Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ticagrelor Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ticagrelor Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ticagrelor How Supplied in the drug label.
Storage
There is limited information regarding Ticagrelor Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ticagrelor Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ticagrelor interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ticagrelor Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ticagrelor Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.