Ticagrelor

Ticagrelor
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS: Maintenance doses of aspirin above 100 mg reduce the effectiveness of Brilinta and should be avoided.

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)

Acute coronary syndromes

• Dosing Information

• Initial dose: “Brilinta 180 mg PO once” with aspirin (325 mg) once.
• Maintenance dose: “Brilinta 90 mg PO bid” with aspirin 75-100 mg PO qd.

• Not recommended when aspirin maintenance dose is above 100 mg.

Percutaneous coronary intervention

• Dosing Information

• Loading dose: “Brilinta 180 mg PO” with aspirin (325 mg), once.
• Maintenance: “Brilinta 90 mg PO bid” with aspirin 75-100 mg qd.

• Use of aspirin maintenance dose above 100 mg is not recommended.
• Consider carefully the continuation of therapy beyond 12 months (for drug-eluting stents).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information about ‘’FDA-Labeled Indications and Dosage” of Ticagrelor tablet in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in pediatric patients.

Contraindications

• History of intracranial hemorrhage
• Active pathological bleeding
• Severe hepatic impairment
• Hypersensitivity to ticagrelor or any component of the product

Warnings

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. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS: Maintenance doses of aspirin above 100 mg reduce the effectiveness of Brilinta and should be avoided.

• 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

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.