Storage and handling
- The doctor prescribed a dosage specific to the patient and his or her condition. Effient® (prasugrel) tablets are not scored or FDA approved to be split, and no studies have been conducted to assess the effect of splitting Effient tablets
Effient offers convenient once-daily maintenance dosing.1
- Effient should be dispensed in the original container. The Effient packaging system has been specifically designed to ensure product performance through the labeled expiration date. Do not repackage into a prescription vial, pill box, or pill-reminder container. Multiple-month Effient prescription fills should not be condensed into one prescription vial
- There have been no studies evaluating product performance or stability in alternative, after-market storage systems, including unit-dose systems. Effient tablets are susceptible to oxidative and hydrolytic degradation. The manufacturer-supplied nitrogen-inerted packaging is designed to ensure that the quality of the tablets is maintained through the expiration date printed on the container, provided that the container is not opened
SELECTED SAFETY: SIGNIFICANT BLEEDING RISK
Effient can cause significant, sometimes fatal, bleeding. In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (diabetes or prior MI) where its effect appears to be greater and its use may be considered.
References: 1. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company. 2. Data on file: #EFF20120516a: DSI/Lilly.
Effient® (prasugrel) 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
The loading dose (LD) of Effient is 60 mg and the maintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.
IMPORTANT SAFETY INFORMATION
WARNING: BLEEDING RISK
Effient® (prasugrel) can cause significant, sometimes fatal, bleeding.
Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.
In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.
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.
Additional risk factors for bleeding include:
- body weight <60 kg
- propensity to bleed
- concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs])
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.
If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.
- Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product
WARNINGS AND PRECAUTIONS
- Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery
- Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death
- Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis
- Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines
- Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction
Please see Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.
For Healthcare Professionals
The information contained at EffientHCP.com is technical in nature and was specifically created for US Healthcare Professionals. If you are not a US Healthcare Professional, please click the “Cancel” button below.
Yes, I am a US Healthcare Professional and would like to continue.
You are now leaving the EffientHCP.com web site.
Click "Continue" to proceed or "Return" to return to EffientHCP.com.