Label: TICAGRELOR tablet, film coated

  • NDC Code(s): 0480-2688-06, 0480-2695-06
  • Packager: Teva Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 20, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TICAGRELOR TABLETS safely and effectively. See full prescribing information for TICAGRELOR TABLETS. TICAGRELOR tablets, for oral ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: BLEEDING RISK

    • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding (5.1, 6.1).
    • Do not use ticagrelor in patients with active pathological bleeding or a history of intracranial hemorrhage (4.1, 4.2).
    • Do not start ticagrelor in patients undergoing urgent coronary artery bypass graft surgery (CABG) (5.1, 6.1).
    • If possible, manage bleeding without discontinuing ticagrelor. Stopping ticagrelor increases the risk of subsequent cardiovascular events (5.2).
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  • 1 INDICATIONS AND USAGE
    1.1   Acute Coronary Syndrome or a History of - Myocardial Infarction - Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Instructions - Advise patients who miss a dose of ticagrelor tablets to take their next dose at its scheduled time. For patients who are unable to swallow tablets whole, ticagrelor ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Ticagrelor tablets 60 mg is supplied as a light yellow to yellow, oval shaped, film-coated tablet debossed with “137” on one side and “A” on the other side. Ticagrelor tablets 90 mg is supplied as ...
  • 4 CONTRAINDICATIONS
    4.1 History of Intracranial Hemorrhage - Ticagrelor is contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Bleeding - Drugs that inhibit platelet function including ticagrelor increase the risk of bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. Patients treated ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.1)] Dyspnea [see Warnings and Precautions (5.3)] 6.1 Clinical Trials ...
  • 7 DRUG INTERACTIONS
    7.1 Strong CYP3A Inhibitors - Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of dyspnea, bleeding, and other adverse events. Avoid use of strong ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from case reports with ticagrelor use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse ...
  • 10 OVERDOSAGE
    There is currently no known treatment to reverse the effects of ticagrelor, and ticagrelor is not dialyzable. Treatment of overdose should follow local standard medical practice. Bleeding is the ...
  • 11 DESCRIPTION
    Ticagrelor is a cyclopentyltriazolopyrimidine inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Ticagrelor was not carcinogenic in the mouse at doses up to 250 mg/kg/day or in the male rat at doses up to 120 ...
  • 14 CLINICAL STUDIES
    14.1 Acute Coronary Syndromes and Secondary Prevention after Myocardial Infarction - PLATO - PLATO (NCT00391872) was a randomized double-blind study comparing ticagrelor (N=9,333) to clopidogrel ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Ticagrelor tablets are available as follows: 60 mg - Light yellow to yellow, oval shaped, film-coated tablet debossed with “137” on one side and “A” on the other side. Tablets are supplied in ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that ...
  • MEDICATION GUIDE
    Dispense with Medication Guide available at: www.tevausa.com/medguides - MEDICATION GUIDE - Ticagrelor (tye ka' grel or) Tablets  - What is the most important information I should know ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 0480-2688-06 - Ticagrelor Tablets - 60 mg - PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only  - 60 Tablets
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 0480-2695-06 - Ticagrelor Tablets - 90 mg - PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only  - 60 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information