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.

CONTRAINDICATIONS

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

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Full Prescribing Information, including Boxed Warning regarding bleeding risk.

PGHCPISI03Oct2011.

Clinical Guidelines

Effient is included in guidelines for UA/NSTEMI and STEMI patients undergoing PCI. Continue reading

ACS-PCI Patients
With Diabetes

Learn about using Effient to treat ACS-PCI patients with diabetes. Continue reading

Clinical Data

See clinical data from TRITON-TIMI 38 that shows how Effient compared with Plavix in ACS-PCI patients. Continue reading

Patient Case Studies

This page includes example patient case studies for acute coronary syndrome (ACS) patients who are managed with PCI.

UA/NSTEMI Patient With Diabetes
STEMI Patient With a Prior MI
Unstable Angina Patient

UA/NSTEMI Patient With Diabetes

Clinical Presentation

53-year-old African-American man
Height: 6′0″; weight: 220 lb (100 kg)
Presented by ambulance to ED at 6 pm on a Thursday with severe 6/10 chest pain, which lasted 30 minutes
Currently pain free

History

No previous stroke or TIA
No smoking history
Sedentary lifestyle, rarely exercises
Father has hypertension, alive
Diabetes and hyperlipidemia for the past 7 years
- Currently on an oral hypoglycemic agent and a statin

Patient Evaluation

BP 111/89 mm Hg
HR 54 bpm
Physical exam
- No relevant findings
- No focal neurologic findings
Noninvasive
- ECG: Sinus bradycardia, left atrial enlargement; ST-T wave abnormality in most leads
- Troponin 0.3 ng/mL (ULN 0.1)
- CK-MB 9.5 ng/mL (ULN 7.0)

Diagnosis From ED

NSTEMI – to be managed with PCI during hospitalization

*Not pictured above: Minimal disease in the left coronary artery.

SELECTED SAFETY: CONTRAINDICATIONS

Effient^® (prasugrel) is contraindicated 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. Click here for Safety Information and Boxed Warning.

STEMI Patient With a Prior MI

Clinical Presentation

67-year-old white man
Height: 5′10″; weight: 187 lb (85 kg)
Presented by ambulance to ED with severe 10/10 chest pain
Chest pain ongoing for about 50 minutes

History

No previous stroke or TIA
Previously diagnosed with hypertension and hypercholesterolemia
Anterior MI 7 months ago treated successfully with DES
Still smoking despite previous MI

LAD, Stent Thrombosis

Patient Evaluation

BP 152/81 mm Hg
HR 106 bpm
Noninvasive
- ECG: Q waves in V1-2, ST elevation V1-V4

Physical exam

No JVP elevation
S3 and S4 gallops present
Lungs: rales at bases
No edema
No focal neurologic findings

Diagnosis From ED

STEMI (proceeding directly to PCI), possible stent thrombosis

SELECTED SAFETY: CONTRAINDICATIONS

Unstable Angina Patient

Clinical Presentation

54-year-old Hispanic man
Height: 5′11″; weight: 210 lb (96 kg)
Presented with intermittent chest pain over the past week and increasing in intensity for the past 2 hours
Chest pain subsided after treatment with sublingual nitroglycerin
Intermittent chest tightness over the past week

History

No previous stroke or TIA
No prior cardiac history
Father had fatal MI at age 62
Hyperlipidemia, currently treated with a statin
Overweight and rarely exercises
Consumes moderate amount of alcohol

Patient Evaluation

BP 137/90 mm Hg
HR 87 bpm
TC 265 mg/dL, LDL 190 mg/dL, HDL 44 mg/dL, TG 176 mg/dL
Physical exam
- No relevant findings
- No focal neurologic findings

Noninvasive

ECG: ST and T-wave abnormality in the anterior and lateral leads
Troponin 0.07 ng/mL (ULN 0.1)
CK-MB 5.2 ng/mL (ULN 8.0)

Diagnosis From ED

UA – to be managed with PCI during hospitalization

SELECTED SAFETY: CONTRAINDICATIONS

INDICATION

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 of Effient is 60 mg and the maintenance dose 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.

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])

CONTRAINDICATIONS

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

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Full Prescribing Information, including Boxed Warning regarding bleeding risk.

PGHCPISI03Oct2011.

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Prescribing Information | Medication Guide | Safety Information and Boxed Warning

^®Effient and the Effient logo are registered trademarks of Eli Lilly and Company.

Plavix^® is a registered trademark of sanofi-aventis Corp.

This site is intended for US Healthcare Professionals Only.

PGHCPISI03Oct2011.

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Clinical Guidelines

ACS-PCI PatientsWith Diabetes

Clinical Data

Patient Case Studies

UA/NSTEMI Patient With Diabetes

Clinical Presentation

History

Patient Evaluation

Diagnosis From ED

SELECTED SAFETY: CONTRAINDICATIONS

STEMI Patient With a Prior MI

Clinical Presentation

History

Patient Evaluation

Physical exam

Diagnosis From ED

SELECTED SAFETY: CONTRAINDICATIONS

Unstable Angina Patient

Clinical Presentation

History

Patient Evaluation

Noninvasive

Diagnosis From ED

SELECTED SAFETY: CONTRAINDICATIONS

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For Healthcare Professionals

ACS-PCI Patients
With Diabetes

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