BRILINTA Film-coated tablet (2021)

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AstraZeneca Pharmaceuticals LP

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BOXED WARNING SECTION

WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS IN PATIENTS WITH ACS A. BLEEDING RISK BRILINTA, like other antiplatelet agents, can cause significant, sometimes ...

1. Indications and Usage

1.1 Acute Coronary Syndrome or a History of Myocardial Infarction BRILINTA is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary ...

2. Dosage and Administration

2.1 Acute Coronary Syndrome or a History of Myocardial Infarction Initiate treatment with a 180 mg loading dose of BRILINTA. Administer 90 mg of BRILINTA twice daily during the first year after an ACS ...

3. Dosage Forms and Strengths

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet marked with a 90 above T on one side. BRILINTA (ticagrelor) 60 mg is supplied as a round, biconvex, pink, film-coated ...

4. Contraindications

4.1 History of Intracranial Hemorrhage BRILINTA is contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical ...

5. Warnings and Precautions

5.1 Risk of Bleeding Drugs that inhibit platelet function including BRILINTA increase the risk of bleeding [see Adverse Reactions (6.1) and Warnings and Precautions (5.4)]. Patients treated for ...

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 Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BRILINTA. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible ...

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 inhibitors of ...

8.1. Pregnancy

Risk Summary Available data from case reports with BRILINTA use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Ticagrelor and its metabolites were ...

8.4. Pediatric Use

The safety and effectiveness of BRILINTA in pediatric patients have not been established.

8.5. Geriatric Use

About half of the patients in PLATO, PEGASUS, THEMIS, and THALES were ≥65 years of age and at least 15% were ≥75 years of age. No overall differences in safety or effectiveness were observed between elderly ...

8.6. Hepatic Impairment

Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Avoid use of BRILINTA in patients with severe hepatic impairment. There is ...

8.7. Renal Impairment

No dosage adjustment is needed in patients with renal impairment [see Clinical Pharmacology (12.3)]. Patients with End-Stage Renal Disease on dialysis Clinical efficacy and safety studies with ...

10. Overdosage

There is currently no known treatment to reverse the effects of BRILINTA, and ticagrelor is not dialyzable. Treatment of overdose should follow local standard medical practice. Bleeding is the expected ...

11. Description

BRILINTA contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S ...

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 active metabolite are ...

12.2. Pharmacodynamics

The inhibition of platelet aggregation (IPA) by ticagrelor and clopidogrel was compared in a 6-week study examining both acute and chronic platelet inhibition effects in response to 20 μM ADP as the platelet ...

12.3. Pharmacokinetics

Ticagrelor demonstrates dose proportional pharmacokinetics, which are similar in patients and healthy volunteers. Absorption BRILINTA can be taken with or without food. Absorption of ticagrelor occurs ...

12.5. Pharmacogenomics

In a genetic substudy cohort of PLATO, the rate of thrombotic CV events in the BRILINTA arm did not depend on CYP2C19 loss of function status.

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 mg/kg/day (19 and 15 times the MRHD of 90 mg twice daily on the basis of AUC, ...

14. Clinical Studies

14.1 Acute Coronary Syndromes and Secondary Prevention after Myocardial Infarction PLATO PLATO (NCT00391872) was a randomized double-blind study comparing BRILINTA (N=9333) to clopidogrel (N=9291), both ...

16.1. How Supplied

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet with a 90 above T on one side: Bottles of 60 – NDC 0186-0777-60 100 count Hospital Unit Dose – NDC 0186-0777-39 ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature].

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 contain aspirin. ...