BRILINTA TABLET 90 MG [SIN14120P]

Product Info

BRILINTA TABLET 90 MG

[SIN14120P]

4.1 Therapeutic indications

BRILINTA, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute Coronary Syndromes (ACS) (unstable angina, non-ST elevation Myocardial Infarction [NSTEMI], or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

4.2 Posology and method of administration

In patients with Acute Coronary Syndromes, 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. Treatment is recommended for at least 12 months unless discontinuation of BRILINTA is clinically indicated (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). After one year, patients with MI initiated on 90 mg may continue treatment with 60 mg without interruption if they have a high risk of an atherothrombotic event.

Patients taking BRILINTA should also take a daily low maintenance dose of acetylsalicylic acid (ASA) of 75–150 mg, unless specifically contraindicated. An initial loading dose of ASA, is recommended for patients with ACS (see section Pharmacodynamics properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Missed dose

Lapses in therapy should be avoided. A patient who misses a dose of BRILINTA should take their next dose at its scheduled time.

Switching

Physicians who desire to switch patients, with a prior ACS event to BRILINTA, should administer the first 90 mg dose of BRILINTA 24 hours following the last dose of other antiplatelet medication (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Premature discontinuation

Premature discontinuation with any antiplatelet therapy, including BRILINTA, could result in an increased risk of cardiovascular (CV) death, myocardial infarction (MI), or stroke due to the patient’s underlying disease (see section Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration

For oral use. BRILINTA can be taken with or without food. For patients who are unable to swallow the tablet(s) whole, BRILINTA tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture.

Special Populations

Paediatric patients:

Safety and efficacy in children below the age of 18 have not been established (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly patients:

No dose adjustment is required.

Patients with renal impairment:

No dose adjustment is necessary for patients with renal impairment (see section Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment:

No dose adjustment is necessary for patients with mild hepatic impairment. BRILINTA has not been studied in patients with severe hepatic impairment and there is limited information on treatment of patients with moderate hepatic impairment (see section Contraindications, Special warnings and special precautions for use, and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to ticagrelor or any of the excipients (see section Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Active pathological bleeding.

• History of intracranial haemorrhage (see section Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe hepatic impairment (see section Posology and method of administration, Special warnings and special precautions for use and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor (see section Special warnings and special precautions for use and Interaction with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).