Clinical Information
Gen. Code and Des.
64901 prasugrel HCl ORAL TABLET 5 MG
GCN and Des.
17056 prasugrel HCl ORAL TABLET 5 MG
Strength
5MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
20121800 PLATELET-AGGREGATION INHIBITORS
Active Ingredients
12995 prasugrel HCl 389574190
Inactive Ingredients
2272 mannitol 69658
2432 lactose 64044515
2598 sucrose 57501
These highlights do not include all the information needed to use EFFIENT safely and effectively. See full prescribing information for EFFIENT.
EFFIENT ® (prasugrel) tablets, for oral use
Initial U.S. Approval: 2009
WARNING: BLEEDING RISK
See full prescribing information for complete boxed warning.
Effient can cause significant, sometimes fatal, bleeding ( 5.1, 5.2, 6.1).
Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke ( 4.1, 4.2).
In patients ≥75 years of age, Effient is generally not recommended, except in high-risk patients (diabetes or prior myocardial infarction [MI]), where its use may be considered ( 8.5).
Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery ( 5.2).
Additional risk factors for bleeding include: body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding ( 5.1).
Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical procedures ( 5.1).
If possible, manage bleeding without discontinuing Effient. Stopping Effient increases the risk of subsequent cardiovascular events ( 5.3).
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).
DOSAGE AND ADMINISTRATION
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).
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets ( 3)
CONTRAINDICATIONS
Active pathological bleeding ( 4.1)
Prior transient ischemic attack or stroke ( 4.2)
Hypersensitivity to prasugrel or any component of the product ( 4.3)
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).
ADVERSE REACTIONS
Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Opioids: Decreased exposure to prasugrel. Consider use of parenteral antiplatelet agent ( 7.3).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 2/2022
