Indicated for:

Acute Coronary Syndrome:

• 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.

Effient 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.

Effient is contraindicated:

• in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage and
• in patients with a history of prior transient ischemic attack (TIA) 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 patients (diabetes or prior MI), where its effect appears to be greater and its use may be considered.

Additional risk factors for bleeding include:

• CABG or other surgical procedure
• body weight < 60 kg
• propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate to severe renal impairment)
• concomitant use of medications that increase the risk of bleeding (e.g., oral anticoagulants, chronic use of non-steroidal antiinflammatory drugs [NSAIDs], and fibrinolytic agents)

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. Stopping Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

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.

Thrombotic thrombocytopenic purpura (TTP) has been reported with the use of Effient. TTP can occur after a brief exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment, including plasmapheresis (plasma exchange).

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.

Thienopyridines inhibit platelet aggregation for the lifetime of the platelet (7-10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of prasugrel’s active metabolite is short relative to the lifetime of the platelet, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

Co-administration of Effient and warfarin increases the risk of bleeding.

Co-administration of Effient and NSAIDs (used chronically) may increase the risk of bleeding.

As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of prasugrel’s active metabolite presumably because of slowed gastric emptying.

There are no data with Effient use in pregnant women to inform a drug-associated risk. Due to the mechanism of action of Effient, and the associated identified risk of bleeding, consider the  benefits and risks of Effient and possible risks to the fetus when prescribing Effient to a pregnant woman.

There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. Metabolites of prasugrel were found in rat milk.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Use in patient without histories of acute coronary syndromes or not undergoing percutaneous coronary intervention. GoToSource 

• Administering prasugrel at the time of percutaneous coronary intervention and switching to clopidogrel without reloading. GoToSource

New solid neoplasms and cancer deaths. GoToSource

Impaired wound healing, higher infection risks including sepsis and systemic inflammatory response syndrome. GoToSource 

Hypersensitivity including angioedema. GoToSource

Bleeding complications. GoToSource

Lawsuits filed for new or worsening solid tumors.