Generic Effient

What it is used for

1 INDICATIONS AND USAGE Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Effient ® is indicated to reduce the rate of thrombotic 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 diffe

How it is taken

2 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 (7.4) and Clinical Pharmacology (12.3) ] . Effient may be administered with or without food [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . Initiate treatment with a single 60 mg oral loading dose ( 2 ). Continue at 10 mg once daily with or without food. Consider 5 mg once daily for patients <60 kg ( 2 ). Patients should also take aspirin (75 mg to 325 mg) daily ( 2 ). 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 (14) ] . For the small fraction of patients that required urgent CABG after treatment with E

Warnings

5 WARNINGS AND PRECAUTIONS CABG-related bleeding: Risk increases in patients receiving Effient who undergo CABG ( 5.2 ). Discontinuation of Effient: Premature discontinuation increases risk of stent thrombosis, MI, and death ( 5.3 ). Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Effient ( 5.4 ). Hypersensitivity: Hypersensitivity including angioedema has been reported with Effient including in patients with a history of hypersensitivity reaction to other thienopyridines ( 5.5 ). 5.1 General Risk of Bleeding Thienopyridines, including Effient, increase the risk of bleeding. With the dosing regimens used in TRITON-TIMI 38, TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL, or intracranial hemorrhage) and TIMI Minor (overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL), bleeding events were more common on Effient than on clopidogrel [see Adverse Reactions (6.1) ] . The bleeding risk is highest initially, as shown in Figure 1 (events through 450 days; inset shows events through 7 days). Figure 1: Non-CABG-Related TIMI Major or Minor Bleeding Events Suspect bleeding in

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.