BRILINTA

BRILINTA- ticagrelor tablet
AstraZeneca Pharmaceuticals LP

WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

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

Maintenance doses of aspirin above 100 mg daily reduce the effectiveness of BRILINTA and should be avoided ( 2.3 , 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 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).

2 DOSAGE AND ADMINISTRATION

2.1 Acute Coronary Syndrome or a History of Myocardial Infarction

In the management of ACS, initiate BRILINTA treatment with a 180 mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year, administer 60 mg twice daily.

2.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction

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

2.3 Administration

Administer BRILINTA with a daily maintenance dose of aspirin of 75-100 mg [see Warnings and Precautions (5.2) and Clinical Studies (14)]. A patient who misses a dose of BRILINTA should take one tablet (their next dose) at its scheduled time.

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 General Risk of Bleeding

Drugs that inhibit platelet function including BRILINTA increase the risk of bleeding [see Adverse Reactions (6.1)].

If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

5.2 Concomitant Aspirin Maintenance Dose

In PLATO the use of BRILINTA with maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Therefore, after the initial loading dose of aspirin, use BRILINTA with a maintenance dose of aspirin of 75-100 mg [see Dosage and Administration (2.3) and Clinical Studies (14.1)].

5.3 Dyspnea

In clinical trials, about 14% (PLATO and PEGASUS) to 21% (THEMIS) of patients treated with BRILINTA developed dyspnea. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment but led to study drug discontinuation in 0.9 % (PLATO), 4.3% (PEGASUS), and 6.9% (THEMIS) of patients.

In a substudy of PLATO, 199 subjects underwent pulmonary function testing irrespective of whether they reported dyspnea. There was no indication of an adverse effect on pulmonary function assessed after one month or after at least 6 months of chronic treatment.

If a patient develops new, prolonged, or worsened dyspnea that is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption if possible. In the case of intolerable dyspnea requiring discontinuation of BRILINTA, consider prescribing another antiplatelet agent.

5.4 Discontinuation of BRILINTA

Discontinuation of BRILINTA will increase the risk of myocardial infarction, stroke, and death. If BRILINTA must be temporarily discontinued (e.g., to treat bleeding or for significant surgery), restart it as soon as possible. When possible, interrupt therapy with BRILINTA for five days prior to surgery that has a major risk of bleeding. Resume BRILINTA as soon as hemostasis is achieved.

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