Mandatory Indications-ISIMandatory Indications-ISI

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An Overview of Efficacy and Safety Information

DISEASE STATE/QUALITYHCR INFORMATION

UNBRANDED PROGRAMSAND RESOURCES

PRODUCTINFORMATION

BRANDED PROGRAMSAND RESOURCES

EFFIENT VALUE MESSAGE

Mandatory Indications-ISIMandatory Indications-ISI

An Overview of Efficacy and Safety Information for Effient® (prasugrel)

DISEASE STATE/QUALITYHCR INFORMATION

UNBRANDED PROGRAMSAND RESOURCES

PRODUCTINFORMATION

BRANDED PROGRAMSAND RESOURCES

EFFIENT VALUE MESSAGE

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POPULATION OVERVIEW INITIATION MAINTENANCE SUPPORTING INFO

Symptoms Onset Where Treatment is Initiated in ACS-PCI Patients

Feeder Hospital

Coronary Care Unit

Emergency Department

Cath Lab

First Rx Fill by Patient

Rx Maintained inFollow-up Visits

Office-based Cardiologists

IM’s/PCP’s

Rx Refills by Patient

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SELECTED SAFETY: DISCONTINUATION OF EFFIENT

PRO

TOCO

LSM

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Patient FlowInitiation of Antiplatelet Therapy and Outpatient Maintenance

First Rx Fill by Patient

Rx Maintained inFollow-up Visits

Office-based Cardiologists

IM’s/PCP’s

Rx Refills by Patient

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Patients who experience stroke or TIA generally should discontinue therapy. Effient should also be is continued for active bleeding and elective surgery. If possible, manage bleeding without discontinuing. Premature discontinuation, particularly in the first few weeks after ACS, increases risk of stent thrombosis, MI, and death.

Symptoms Onset

POPULATION OVERVIEW

INITIATION

MAINTENANCE SUPPORTING INFO

• PREVALENCE

• BURDEN OF DISEASE

• GUIDELINES

• PATIENT SELECTION

• TRITON-TIMI 38

• PREDICTABLE ANTIPLATELET EFFECTS

• REDUCTIONS IN THROMBOTIC CV EFFECTS

• CONTINUOUS RISK REDUCTION

• DOSING

• CONCOMMITANT MEDICATIONS

• SUMMARY

SELECTED SAFETY: DISCONTINUATION OF EFFIENT

Patient FlowInitiation of Antiplatelet Therapy and Outpatient Maintenance

Prevalence

OVERVIEW

Nearly 594,000 ACS patients are managed with PCI annually

BURDENPREVALENCE

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ASA offers convenient once-daily maintenance dosing

Offers a convenient dosing schedule•Simple one-tablet, once-daily maintenance dosingRecommended dosing•Initiate Effient as a single 60-mg oral LD (six 10-mg tablets)•Continue at 10 mg orally once daily•Patients taking Effient should also take aspirin (75 mg to 325 mg) daily•Effient may be administered with or without food

Dosing in low-weight patients• 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 in ACS patients undergoing PCI

Dosage strengths• 5-mg and 10-mg tablets

SELECTED SAFETY: CONTRAINDICATIONSContraindicated in patients with active pathological bleeding, such as from a peptic ulcer or ICH, or a history of TIA or stroke, and in patients with hypersensitivity to prasugrel or any component of the product.