BRILINTA

What it is

BRILINTA contains 90 mg ticagrelor per film-coated tablet. Ticagrelor is an oral, direct acting selective and reversibly binding P2Y12 receptor antagonist that prevents adenosine diphosphate (ADP)-mediated P2Y12 dependent platelet activation and aggregation.

Approved indications

— Prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction or ST elevation myocardial infarction) including patients managed medically, and those managed with percutaneous coronary intervention or coronary artery bypass grafting, in combination with aspirin.

Dosing overview

BRILINTA treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Patients taking BRILINTA should take aspirin daily unless specifically contraindicated, with a recommended maintenance dose of aspirin 100 mg daily.

Key safety warnings

Patients with acute coronary syndrome treated with ticagrelor and aspirin showed an increased risk of non-CABG major bleeding and also more generally in bleeds requiring medical attention. BRILINTA prolongs bleeding time and should be used with caution in patients who may be at risk of increased bleeding; the use of BRILINTA in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events. Dyspnoea is reported by 13.8% of patients treated with ticagrelor in the PLATO study and by 7.8% treated with clopidogrel, with discontinuations due to dyspnoea reported in 0.9% of patients taking ticagrelor and 0.1% of patients taking clopidogrel. Patients with asthma or chronic obstructive pulmonary disorder may have an increased absolute risk of experiencing dyspnoea with BRILINTA. Holter ECG monitoring has shown an increased frequency of mostly asymptomatic ventricular pauses during treatment with ticagrelor compared with clopidogrel. Bradyarrhythmic events and AV blocks have been reported in the post-marketing setting in patients taking ticagrelor, primarily in patients with acute coronary syndrome. Creatinine levels may increase during treatment with ticagrelor; renal function should be checked after one month and thereafter according to routine medical practice paying special attention to patients aged 75 years or older and patients with moderate or severe renal impairment.

Contraindications

BRILINTA is contraindicated in hypersensitivity to ticagrelor or any of the excipients, active pathological bleeding, history of intracranial haemorrhage, and moderate to severe hepatic impairment. Co-administration of ticagrelor with strong CYP3A4 inhibitors (for example ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor.

PBS listing

BRILINTA is currently listed on the PBS. In November 2017, the PBAC recommended an amendment to the current PBS listing to allow ticagrelor to be used for up to 12 months in patients with acute coronary syndrome who are at high risk of ischaemic events. In March 2023, the PBAC did not recommend a change to unrestricted benefit.

Regulatory history

BRILINTA ticagrelor 90 mg tablet was first listed on the ARTG on 21 June 2011. The PBAC reviewed the medicine in March 2016 for acute coronary syndrome. In November 2017, the PBAC recommended an amendment to allow ticagrelor use for up to 12 months in patients with acute coronary syndrome at high risk of ischaemic events. An orodispersible tablet formulation (BRILINTA ODT 90 mg) was subsequently listed on the ARTG on 4 April 2019.