Posology : מינונים

4.2     Posology and method of administration
Posology

Adults
Effient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking Effient should also take ASA daily (75 mg to 325 mg).

In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Effient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’s underlying disease. A treatment of up to 12 months is recommended unless the discontinuation of Effient is clinically indicated (see sections 4.4 and 5.1).

Patients ≥ 75 years old
The use of Effient in patients ≥ 75 years of age is generally not recommended. If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed. Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).

Patients weighing <60 kg
Effient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
The 10 mg maintenance dose is not recommended. This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight <60 kg when given a 10 mg once daily dose compared with patients ≥60 kg (see sections 4.4, 4.8 and 5.2).

Renal impairment
No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2). There is limited therapeutic experience in patients with renal impairment (see section 4.4).

Hepatic impairment
No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2). There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4). Effient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).

Paediatric population
Effient is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.

Method of administration
For oral use. Effient may be administered with or without food. Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2). Do not crush or break the tablet.