Acute Coronary Syndrome

Effient® is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:

• Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.

Effient has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies].

It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of Effient, Effient and the control drug were not administered to UA/NSTEMI patients until coronary anatomy was established. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial [see WARNINGS AND PRECAUTIONS]. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is considered unlikely. The advantages of earlier treatment with Effient must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG.

Initiate Effient treatment as a single 60-mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. Effient may be administered with or without food [see CLINICAL PHARMACOLOGY and Clinical Studies].

Dosing in Low Weight Patients

Compared to patients weighing 60 kg, patients weighing < 60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients < 60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied.

Dosage Forms And Strengths

Effient 5 mg is available as a yellow, elongated hexagonal, film-coated, non-scored tablet:

• debossed with “5 MG” on one side and “4760” on the other side (original formulation)
  OR
• debossed with “5121” on one side and 3 parallel arched lines followed by a “5” on the other side (revised formulation)

Effient 10 mg is available as a beige, elongated hexagonal, film-coated, non-scored tablet:

• debossed with “10 MG” on one side and with “4759” on the other side (original formulation)
  OR
• debossed with “5123” on one side and 3 parallel arched lines followed by a “10” on the other side (revised formulation)

Storage And Handling

Effient (prasugrel) is available as elongated hexagonal, film-coated, non-scored tablets in the following strengths, colors, imprints, and presentations:

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature].

Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.

Revised: 11/2012. Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285. Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLC

Last reviewed on RxList: 12/14/2012
This monograph has been modified to include the generic and brand name in many instances.