ARX-Ticagrelor

What it is

ARX-Ticagrelor is a film-coated tablet containing 90 mg of ticagrelor.

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 by-pass grafting, in combination with aspirin.

Dosing overview

ARX-Ticagrelor 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 ARX-Ticagrelor should take aspirin daily unless specifically contraindicated, with a recommended maintenance dose of aspirin 100 mg daily. If required, the aspirin maintenance dose may vary from 75–150 mg according to clinical need.

Key safety warnings

Patients with acute coronary syndrome treated with ticagrelor and aspirin showed an increased risk of non-coronary artery by-pass grafting major bleeding and bleeds requiring medical attention, but not fatal or life-threatening bleeds. As with other anti-platelet agents, ticagrelor prolongs bleeding time and should be used with caution in patients who may be at risk of increased bleeding; use in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events. Dyspnoea, usually mild to moderate in intensity and often resolving without need for treatment discontinuation, is reported by 13.8% of patients treated with ticagrelor compared to 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 ARX-Ticagrelor and should use it with caution. Holter electrocardiogram monitoring has shown an increased frequency of mostly asymptomatic ventricular pauses during treatment with ticagrelor compared with clopidogrel. Patients with an increased risk of bradycardic events (such as patients without a pacemaker who have sick sinus syndrome, second or third degree atrioventricular block or bradycardic-related syncope) have been excluded from ticagrelor outcome studies, and caution is advised due to limited clinical experience in these patients. 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 and those receiving concomitant treatment with an angiotensin II receptor blocker.

Contraindications

ARX-Ticagrelor is contraindicated in patients with hypersensitivity to ticagrelor or any of the excipients, active pathological bleeding, history of intracranial haemorrhage, moderate to severe hepatic impairment, and in patients receiving strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir).

PBS listing

ARX-Ticagrelor 90 mg tablets are listed on the PBS with streamlined restriction, with an ex-manufacturer price of A$81.59.

Regulatory history

ARX-Ticagrelor ticagrelor 90 mg tablet was first registered on the ARTG on 7 August 2024.