Adult Dosing

Acute Coronary Syndrome

• Loading dose 60 mg PO x 1, then continue at 10 mg PO qd; decrease the maintenance dose to 5 mg PO qd in patients <60 kgs

• Aspirin 75-325 mg PO daily should be administered concomitantly
• Drug can be taken with or without food

Acute Coronary Syndromes [Non-FDA Approved]

• Loading dose of 60 mg PO, then 10 mg PO daily for upto 12 months following treatment of UA/NSTEMI

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
• Unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI)
• ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI

• Hypersensitivity to any of the ingredients of the product
• Active pathological bleeding (peptic ulcer, intracranial hemorrhage)
• History of prior transient ischemic attack or stroke
• CABG surgery within 7 days

• Prasugrel can cause significant, sometimes fatal, bleeding. Do not use in patients with active pathological bleeding or a history of transient ischemic attack or stroke. In patients 75 yrs, therapy is generally not recommended, due to increased risk of fatal and intracranial bleeding and uncertain benefit, except in patients with diabetes or a history of prior MI, where its effect appears to be greater
• Do not initiate therapy in patients likely to undergo urgent coronary artery bypass graft (CABG) surgery. Discontinue therapy at least 7 days prior to any surgery
• Risk factors associated with bleeding include body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (oral anticoagulants, chronic use of NSAIDs, fibrinolytic agents)
• Consider the possibility of bleeding in hypotensive patients, who have recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures, while on prasugrel treatment
• If possible, manage bleeding without discontinuing therapy. Discontinuation, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Mild to moderate impairment (Child-Pugh Class A and B): No dose adjustments
• Severe impairment: Dose adjustments not defined; use with caution

• Suspect bleeding in patients who are hypotensive and have recently undergone coronary angiography, PCI, CABG, or other surgical procedures, while on prasugrel treatment even if the patient does not have overt signs of bleeding
• Risk of bleeding increases in patients receiving prasugrel who undergo CABG or other surgical procedures, in patients <60 kgs body weight, and those with bleeding propensity and concomitant use of drugs known to increase the risk of bleeding. Do not use in patients with active pathological bleeding or a history of transient ischemic attack or stroke [US Black Box Warning]
• Do not initiate therapy in patients likely to undergo urgent CABG; discontinue the drug at least 7 days prior to the surgery. CABG-related bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets [US Black Box Warning]
• Discontinue therapy in case of active bleeding, elective surgery, stroke, or TIA. Premature discontinuation of prasugrel in patients managed with PCI and stent placement increases the risk of stent thrombosis, MI, and death
• Patients requiring premature discontinuation of therapy may be at an increased risk for CV events
• Thrombotic thrombocytopenic purpura (TTP), which can be fatal and requiring urgent treatment, including plasmapheresis, has been reported in patients treated with prasugrel
• Hypersensitivity including angioedema, has been reported in patients receiving treatment with prasugrel

Cautions: Use cautiously in

• Severe hepatic impairment
• History of GI bleed
• Recent surgery or trauma
• Active GI ulcer or disease
• Patients >75 yrs

Pregnancy Category:B

Breastfeeding: It is unknown whether prasugrel is excreted in human milk. Manufacturer advises to use this drug during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.

• CV: Hypertension, hypotension, atrial fibrillation, bradycardia
• CNS: Headache, dizziness, pyrexia, stroke, fatigue, intracranial bleeding
• RESP: Dyspnea, cough
• METABOLIC: Hyperlipidemia, hypercholesterolemia
• HEMA: Leukopenia, anemia, severe thrombocytopenia, TTP, major or minor bleeding, hemorrhage
• EENT: Epistaxis
• GI: Nausea, diarrhea, gastrointestinal hemorrhage, hepatic impairment
• DERM: Rash
• MUSC: Back pain, extremity pain
• HYPERSENSITIVITY: Allergic reactions, angioedema
• MISC: Peripheral edema, pyrexia, non-cardiac chest pain

• Antithrombotic agent; inhibits platelet activation and aggregation via the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets
• Bioavailability: 79%
• Metabolism: Liver; CYP450: 3A4, 2B6 (primarily); 2C9, 2C19 (lesser extent)
• Excretion: Urine (68%), feces (27%)
• Half-life: 7 hrs (range 2-15 hrs)

US Trade Name(s)

• Effient

US Availability

Effient

• TABS: 5, 10 mg

Canadian Trade Name(s)

• Effient

Canadian Availability

Effient

• TABS: 10 mg

UK Trade Name(s)

• Efient

UK Availability

Efient

• TABS: 5, 10 mg

Australian Trade Name(s)

• Effient

Australian Availability

Effient

• TABS: 5, 10 mg

[Outline]

Hematology/Oncology

Antiplatelet Agents

Platelet Aggregation Inhibitors

Cardiovascular

Antiplatelet Agents

Platelet Aggregation Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Effient 10 MG TABS [Bottle] (LILLY)
  30 mg = $215.26
  90 mg = $608.03
• Effient 5 MG TABS [Bottle] (LILLY)
  30 mg = $218
  90 mg = $622

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Effient 10 MG Oral Tablet

Ingredient(s): Prasugrel

Imprint: 10;mg;4759

Color(s): Brown

Shape: Hexagon (6 sides)

Size (mm): 11.00

Score: 1

Inactive Ingredient(s): mannitol / hypromellose / croscarmellose sodium / cellulose, microcrystalline / magnesium stearate / lactose / titanium dioxide / triacetin / ferric oxide yellow / ferric oxide red

Drug Label Author:
Eli Lilly and Company

DEA Schedule:
Non-Scheduled

Drug Name: Effient 5 MG Oral Tablet

Ingredient(s): Prasugrel

Imprint: 5;mg;4760

Color(s): Yellow

Shape: Hexagon (6 sides)

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): mannitol / hypromellose / croscarmellose sodium / cellulose, microcrystalline / magnesium stearate / lactose / titanium dioxide / triacetin / ferric oxide yellow

Drug Label Author:
Eli Lilly and Company

DEA Schedule:
Non-Scheduled