EFIENT

Posology Adults Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. 1). 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.

1). Patients ≥ 75 years old The use of Efient in patients ≥ 75 years of age is generally not recommended. 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.

2). 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. 2). 2). 4). 2). 4). Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).

Paediatric population The safety and efficacy of Efient in children below age 18 has not been established. 1). Method of administration For oral use. Efient may be administered with or without food. 2). Do not crush or break the tablet.

5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year). 3% for clopidogrel. 4% for clopidogrel). Bleeding Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.

The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations.

No significant difference was seen in the STEMI population. 2% with clopidogrel).

Table 1:

Incidence of Non-CABG related bleedinga (% Patients) a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. b Other standard therapies were used as appropriate. c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥ 5 g/dL.

d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below. Patients may be counted in more than one row. e ICH=intracranial haemorrhage. f Clinically overt bleeding associated with a fall in haemoglobin of ≥ 3 g/dL but < 5 g/dL.

1% for clopidogrel. CABG-related bleeding In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study. 5% in the clopidogrel group. The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.

0% (3 of 60 patients) in the clopidogrel group. 4% (3 of 89 patients) in the clopidogrel group. 4). 4). 6 aOther standard therapies were used as appropriate. The clinical study protocol provided for all patients to receive aspirin and a daily […]

Bleeding risk In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings. Patients with acute coronary syndromes undergoing PCI treated with Efient and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.

Therefore, the use of Efient in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings. This concern applies especially to patients: • ≥ 75 years of age (see below).

g. 8). In these patients the 10 mg maintenance dose is not recommended. A 5 mg maintenance dose should be used. • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non- steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.

For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate. The use of Efient in patients ≥ 75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.

In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal bleeding, compared to patients < 75 years of age. 8). Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.

These patients may have an increased bleeding risk. Therefore, prasugrel should be used with caution in these patients. Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.

1. Active pathological bleeding. History of stroke or transient ischaemic attack (TIA). Severe hepatic impairment (Child Pugh class C).