Efient* 5 mg film-coated tablets. Efient 10mg film-coated t(一)
1. NAME OF THE MEDICINAL PRODUCT
Efient* 5 mg film-coated tablets.
Efient 10 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg prasugrel (as hydrochloride).
Excipient: Each tablet contains 2.7 mg lactose.
Each tablet contains 10 mg prasugrel (as hydrochloride).
Excipient: Each tablet contains 2.1 mg lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow and double-arrow-shaped tablets, debossed with “5 MG” on one side and “4760” on the other.
Film-coated tablet (tablet).
Beige and double-arrow-shaped tablets, debossed with “10 MG”on one side and “4759” on the other.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e., unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
For further information please refer to section 5.1.
4.2 Posology and method of administration
Posology
Adults
Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. Patients taking Efient 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 Efient, 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 Efient is clinically indicated (see sections 4.4 and 5.1).
Patients 75 years old
The use of Efient in patients 75 years of age is generally not recommended. If, after a careful individual benefit/risk eva luation 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). The evidence for the 5 mg dose is based only on pharmacodynamic/pharmacokinetic analyses and no clinical data currently exist on the safety of this dose in the patients age group 75 years.
Patients weighing <60 kg
Efient 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. Efficacy and safety of the 5 mg dose have not been prospectively assessed (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). The |
