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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].
DOSAGE AND ADMINISTRATION
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].
Timing Of Loading Dose
In the clinical trial that established the efficacy and safety of Effient, the loading dose of Effient was not administered until coronary anatomy was established in UA/NSTEMI patients and in STEMI patients presenting more than 12 hours after symptom onset. In STEMI patients presenting within 12 hours of symptom onset, the loading dose of Effient was administered at the time of diagnosis, although most received Effient at the time of PCI [see Clinical Studies]. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial.
Although 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 a trial of 4033 NSTEMI patients, no clear benefit was observed when Effient loading dose was administered prior to diagnostic coronary angiography compared to at the time of PCI; however, risk of bleeding was increased with early administration in patients undergoing PCI or early CABG.
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 [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Effient 5-mg is available as a yellow, elongated hexagonal, film-coated, non-scored tablet debossed with “5121” on one side and 3 parallel arched lines followed by a “5” on the other side.
Effient 10-mg is available as a beige, elongated hexagonal, film-coated, non-scored tablet debossed with “5123” on one side and 3 parallel arched lines followed by a “10” on the other side.
Effient (prasugrel) is available as elongated hexagonal, film-coated, non-scored tablets in the following strengths, colors, imprints, and presentations:
|Presentations and NDC Codes|
|Bottles of 30||0002-5121-30||0002-5123-30|
|* Identi Dose®, unit dose medication, Lilly|
Storage And Handling
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.
Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285, USAMarketed by Daiichi Sankyo, Inc. and Lilly USA, LLC. Revised: July 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/22/2016
Additional Effient Information
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