Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Ticagrelor is indicated to reduce the rates of cardiovascular mortality, myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
Ticagrelor reduces the rate of stent thrombosis in patients who have undergone stenting for the treatment of acute coronary syndrome.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Patients taking ticagrelor should take it together with acetylsalicylic acid (ASA) daily, unless specifically contraindicated. After an initial dose of ASA, ticagrelor should be taken along with a maintenance dose of 75 – 100 mg ASA. Treatment should begin with a loading dose of 180 mg ticagrelor (two 90 mg tablets) and then maintained with a dose of 90 mg twice daily.
Treatment is recommended for up to 12 months unless there is a clinical indication to discontinue ticagrelor.
In patients with acute coronary syndrome, early discontinuation of any antiplatelet therapy, including ticagrelor, may increase the risk of cardiovascular death or myocardial infarction due to the patient's underlying condition. Therefore, early discontinuation of treatment should be avoided.
Missed dose
A patient who misses a dose of ticagrelor should take their next dose at its scheduled time.
Special populations
Elderly: No dose adjustment is required in elderly.
Renal impairment: No dose adjustment is necessary for patients with renal impairment. There is no relevant information regarding hemodialysis while treated with this medication. Therefore, ticagrelor is not recommended for these patients.
Hepatic impairment: Ticagrelor has not been studied in patients with severe hepatic impairment and its use in these patients is therefore contraindicated. Only limited information is available in patients with moderate hepatic impairment. Dose adjustment is not recommended, but ticagrelor should be used with caution. No dose adjustment is necessary for patients with mild hepatic impairment.
Paediatric population: The safety and efficacy of ticagrelor in children below the age of 18 years have not been established.
Method of administration:
- For oral use. Ticagrelor can be administered with or without food.
- For patients who are unable to swallow the tablet(s) whole, the 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.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Active pathological bleeding.
- History of intracranial haemorrhage.
- Severe hepatic impairment.
- Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor.