BRILINTA TABLET 60 MG [SIN15294P]

Product Info

BRILINTA TABLET 60 MG

[SIN15294P]

4.1 Therapeutic indications

BRILINTA 60 mg is indicated for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing a thrombotic event.

4.2 Posology and method of administration

BRILINTA 60mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section on clinical efficacy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients with a history of Myocardial Infarction (MI occurred at least one year ago), no loading dose of BRILINTA is required and the recommended dose is 60 mg twice daily.

Patients taking BRILINTA should also take a daily low maintenance dose of acetylsalicylic acid (ASA) of 75–150 mg, unless specifically contraindicated.

Patients should discontinue their current antiplatelet therapy before initiating BRILINTA with low dose ASA at the next scheduled dose.

Patients initiated on BRILINTA 90 mg twice daily at the time of the acute event, after one year, may continue treatment with 60 mg twice daily without interruption. Treatment can also be initiated up to two years from the spontaneous myocardial infarction, or within one year after stopping previous ADP receptor antagonist treatment.

Treatment with BRILINTA should be continued in patients with a history of MI for as long as the patient remains at high risk of an atherothrombotic event for a duration up to three years. Efficacy and safety data are insufficient to establish whether the benefits of BRILINTA still outweigh the risks after three years of extended treatment.

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 to BRILINTA, should administer the first 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).

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 sections 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 sections 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 sections 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).