BRILINTA

BRILINTA- ticagrelor tablet
AstraZeneca Pharmaceuticals LP

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 fatal bleeding (5.1,6.1).
Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage (4.1,4.2).
Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery (CABG) (5.1, 6.1) .
If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events (5.4) .

B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS IN PATIENTS WITH ACS

Maintenance doses of aspirin above 100 mg daily reduce the effectiveness of BRILINTA and should be avoided (2, 5.2, 14.1) .

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 syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.

BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1)].

1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction

BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2) ] . While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM).

1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3) ].

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 event. After one year, administer 60 mg of BRILINTA twice daily.

Use BRILINTA with a daily maintenance dose of aspirin of 75 to 100 mg [see Warnings and Precautions (5.2) and Clinical Studies (14)].

2.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction

Administer 60 mg of BRILINTA twice daily. For all patients with ACS see Dosage and Administration (2.1) .

Use BRILINTA with a daily maintenance dose of aspirin of 75 to 100 mg [see Warnings and Precautions (5.2) and Clinical Studies (14) ] .

2.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

Initiate treatment with a 180 mg loading dose of BRILINTA and then continue with 90 mg twice daily for up to 30 days. The treatment effect accrued early in the course of therapy [see Clinical Studies(14) ] .

Use BRILINTA with a loading dose of aspirin (300 to 325 mg) and a daily maintenance dose of aspirin of 75 to 100 mg [see Warnings and Precautions (5.2) and Clinical Studies (14) ] .

2.4 Administration

For patients who are unable to swallow tablets whole, BRILINTA tablets can be crushed, mixed with water and drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology (12.3)].

Do not administer BRILINTA with another oral P2Y12 platelet inhibitor.

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 tablet marked with “60” above “T” on one side.

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 Studies (14.1), (14.2)].

4.2 Active Bleeding

BRILINTA is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

4.3 Hypersensitivity

BRILINTA is contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.

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 acute ischemic stroke or TIA

Patients at NIHSS >5 and patients receiving thrombolysis were excluded from THALES and use of BRILINTA in such patients is not recommended.

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