PRASUGREL tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PRASUGREL HYDROCHLORIDE (UNII: G89JQ59I13) (PRASUGREL - UNII:34K66TBT99)
Available from:
Liberty Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Prasugrel tablets 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: Prasugrel tablets 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 [see Clinical Studies (14)]. Prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Prasugrel tablets is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel), p
Product summary:
Prasugrel tablets is available as oval, biconvex, film coated tablets, non-scored tablets in the following strengths, colors, deboss, and presentations:  Feature  Strengths  5 mg  10 mg  Tablet color  Yellow  Yellow  Tablet debossed  P5 P1  Presentation and NDC Codes  Bottles of 30  0440-0604-30  0440-0605-30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.
Authorization status:
Abbreviated New Drug Application
Authorization number:
0440-0604-30, 0440-0605-30

PRASUGREL- prasugrel tablet, film coated

Liberty Pharmaceuticals, Inc.

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MEDICATION GUIDE

Prasugrel (PRA-soo-grel) tablets

Read this Medication Guide before you start taking Prasugrel tablets and each time you get a refill. There

may be new information. This Medication Guide does not take the place of talking with your doctor about

your medical condition or your treatment.

What is the most important information I should know about Prasugrel tablets?

Prasugrel tablets is used to lower your chance of having a heart attack or other serious problems with your

heart or blood vessels. But, Prasugrel tablets can cause bleeding, which can be serious, and sometimes lead to

death. You should not start to take Prasugrel tablets if it is likely that you will have heart bypass surgery

(coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take

Prasugrel tablets and then have heart bypass surgery.

Do not take Prasugrel tablets if you:

currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head

have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)

are allergic to prasugrel or any of the ingredients in Prasugrel tablets. See the end of this Medication Guide

for a list of ingredients in Prasugrel tablets.

Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you may be

having a stroke or TIA include:

sudden slurring of speech,

sudden weakness or numbness in one part of your body,

sudden blurry vision, or sudden severe headache.

If you have a stroke or TIA while taking Prasugrel tablets, your doctor will probably stop your Prasugrel

tablets. Follow your doctor's instructions about stopping Prasugrel tablets. Do not stop taking Prasugrel

tablets unless your doctor tells you to.

Before having any surgery you should talk to your doctor about stopping Prasugrel tablets. If possible,

Prasugrel tablets should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor

who prescribed Prasugrel tablets for you.

Your risk of bleeding while taking Prasugrel tablets may be higher if you also:

have had trauma, such as an accident or surgery

have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer

have severe liver problems

have moderate to severe kidney problems

weigh less than 132 pounds

take other medicines that increase your risk of bleeding, including:

warfarin sodium (Coumadin*, Jantoven*)

a medicine that contains heparin

other medicines to prevent or treat blood clots

regular daily use of non-steroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your medicine is

one listed above.

Prasugrel tablets increases your risk of bleeding because it lessens the ability of your blood to clot. While

you take Prasugrel tablets:

you will bruise and bleed more easily

you are more likely to have nose bleeds

it will take longer for any bleeding to stop

Call your doctor right away if you have any of these signs or symptoms of bleeding:

unexpected bleeding or bleeding that lasts a long time

bleeding that is severe or you cannot control

pink or brown urine

red or black stool (looks like tar)

bruises that happen without a known cause or get larger

cough up blood or blood clots

vomit blood or your vomit looks like “coffee grounds”

Do not stop taking Prasugrel tablets without talking to the doctor who prescribes it for you. People who are

treated with angioplasty and have a stent, and stop taking Prasugrel tablets too soon, have a higher risk of a

blood clot in the stent, having a heart attack, or dying. If you must stop Prasugrel tablets because of bleeding,

your risk of a heart attack may be higher. See “What are the possible side effects of Prasugrel tablets?” for

more information about side effects.

What is Prasugrel tablets?

Prasugrel tablets is a prescription medicine used to treat people who:

have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen, and

have been treated with a procedure called “angioplasty” (also called balloon angioplasty).

Prasugrel tablets is used to lower your chance of having another serious problem with your heart or blood

vessels, such as another heart attack, a stroke, blood clots in your stent, or death.

Platelets are blood cells that help with normal blood clotting. Prasugrel tablets helps prevent platelets from

sticking together and forming a clot that can block an artery or a stent.

It is not known if Prasugrel tablets is safe and works in children.

What should I tell my doctor before taking Prasugrel tablets?

Prasugrel tablets may not be right for you. Tell your doctor about all of your medical conditions, including if

you:

have any bleeding problems

have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)

are allergic to any medicines, including clopidogrel (Plavix*) or ticlopidine hydrochloride (Ticlid*)

have a history of stomach ulcers, colon polyps, diverticulosis

have liver problems

have kidney problems

have had any recent severe injury or surgery

plan to have surgery or a dental procedure. See “What is the most important information I should know

about Prasugrel tablets?”

pregnant, or are planning to get pregnant. It is not known if Prasugrel tablets will harm your baby.

if you are breast-feeding. It is not known if Prasugrel passes into your breast-milk. You and your doctor

should decide if you will take Prasugrel tablets or breast-feed. You should not do both without talking with

your doctor.

Tell all of your doctors and dentists that you are taking Prasugrel tablets. They should talk to the doctor who

prescribed Prasugrel tablets for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines,

vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. See “What is the

most important information I should know about Prasugrel tablets?”

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a

new medicine.

How should I take Prasugrel tablets?

Take Prasugrel tablets exactly as prescribed by your doctor.

Take Prasugrel tablets one time each day.

You can take Prasugrel tablets with or without food.

Take Prasugrel tablets with aspirin as instructed by your doctor.

Your doctor will decide how long you should take Prasugrel tablets. Do not stop taking Prasugrel tablets

without first talking to the doctor who prescribed it for you. See “What is the most important information I

should know about Prasugrel tablets?”

If you miss a dose, take Prasugrel tablets as soon as you remember. If it is almost time for your next dose,

skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time

unless your doctor tells you to.

If you take too much Prasugrel tablets, call your local emergency room or poison control center right away.

Call your doctor or healthcare provider right away if you fall or injure yourself, especially if you hit your

head. Your doctor or healthcare provider may need to check you.

What are the possible side effects of Prasugrel tablets?

Prasugrel tablets can cause serious side effects, including:

See “What is the most important information I should know about Prasugrel tablets?”

A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with

Prasugrel tablets, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where

blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital

right away, because you may die. Get medical help right away if you have any of these symptoms and they

cannot be explained by another medical condition:

purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to bleeding

under the skin

paleness or jaundice (a yellowish color of the skin or eyes)

feeling tired or weak

fever

fast heart rate or feeling short of breath

headache, speech changes, confusion, coma, stroke, or seizure

low amount of urine or urine that is pink-tinged or has blood in it

stomach area (abdominal) pain, nausea, vomiting, or diarrhea

visual changes

Serious allergic reactions. Serious allergic reactions can happen with Prasugrel tablets, or if you have had a

serious allergic reaction to the medicine clopidogrel (Plavix*) or ticlopidine (Ticlid*). Get medical help right

away if you get any of these symptoms of a severe allergic reaction while taking Prasugrel tablets.

swelling or hives of your face, lips, in or around your mouth, or throat

trouble breathing or swallowing

chest pain or pressure

dizziness or fainting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Prasugrel tablets. For more information, ask your doctor or

pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-

1088.

How should I store Prasugrel tablets?

Keep Prasugrel tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Prasugrel tablets in the container it comes in.

Keep the container closed tightly with the gray cylinder inside.

Protect Prasugrel tablets from moisture.

Keep Prasugrel tablets and all medicines out of the reach of children.

General Information about Prasugrel tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

Prasugrel tablets for a condition for which it was not prescribed. Do not give your Prasugrel tablets to other

people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Prasugrel tablets. If you would like

more information about Prasugrel tablets, talk with your doctor or pharmacist. For more information, call

877-272-7901.

What are the ingredients in Prasugrel tablets?

Active Ingredient: prasugrel

Inactive Ingredients: mannitol, hypromellose, stearic acid, microcrystalline cellulose, Glyceryl behenate and

low substituted hydroxypropyl cellulose.

The color coatings contain lactose monohydrate, hypromellose, titanium dioxide, triacetin and iron (Ferric)

oxide yellow.

Trademarks are the property of their respective owners.

Manufactured by:

Windlas Healthcare (P) Ltd.

Plot No.: 183 & 192, Mohabewala Industrial Area,

Dehradun-248110, Uttarakhand-INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: 10/2017

Revised: 8/2019

Document Id: 60853d14-ac2a-4e48-9c0c-afd8069b83c6

34391-3

Set id: 60853d14-ac2a-4e48-9c0c-afd8069b83c6

Version: 1

Effective Time: 20190801

Liberty Pharmaceuticals, Inc.

PRASUGREL- prasugrel tablet, film coated

Liberty Pharmaceuticals, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRASUGREL TABLETS safely and

effectively. See full prescribing information for PRASUGREL TABLETS.

PRASUGREL tablets, for oral use

Initial U.S. Approval: 2009

WARNING: BLEEDING RISK

See full prescribing information for complete boxed warning.

RECENT MAJOR CHANGES

Dosage and Administration (2) 07/2015

INDICATIONS AND USAGE

Prasugrel tablets is a P2Y platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including

stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows:

DOSAGE AND ADMINISTRATION

Initiate treatment with a single 60-mg oral loading dose (2).

Continue at 10-mg once daily with or without food. Consider 5-mg once daily for patients <60 kg (2).

Patients should also take aspirin (75-mg to 325-mg) daily.

DOSAGE FORMS AND STRENGTHS

5-mg and 10-mg tablets (3)

CONTRAINDICATIONS

Active pathological bleeding (4.1)

Prior transient ischemic attack or stroke (4.2)

Hypersensitivity to prasugrel or any component of the product (4.3)

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction (6.1).

Prasugrel tablets can cause significant, sometimes fatal, bleeding (5.1,5.2, 6.1).

Do not use Prasugrel tablets in patients with active pathological bleeding or a history of transient is

chemic attack or stroke (4.1, 4.2).

In patients ≥75 years of age, Prasugrel tablets is generally not recommended, except in high-risk

patients (diabetes or prior MI), where its use may be considered (8.5).

Do not start Prasugrel tablets in patients likely to undergo urgent coronary artery bypass graft

surgery (CABG). When possible, discontinue Prasugrel tablets at least 7 days prior to any surgery

(5.2).

Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant

use of medications that increase the risk of bleeding (5.1).

Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical

procedures (5.1).

If possible, manage bleeding without discontinuing Prasugrel tablets. Stopping Prasugrel tablets

increases the risk of subsequent cardiovascular events (5.3).

Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1).

Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).

CABG-related bleeding: Risk increases in patients receiving Prasugrel tablets who undergo CABG (5.2).

Discontinuation of Prasugrel tablets: Premature discontinuation increases risk of stent thrombosis, MI, and death

(5.3).

Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Prasugrel tablets (5.4).

Hypersensitivity: Hypersensitivity including angioedema has been reported with Prasugrel tablets including in

patients with a history of hypersensitivity reaction to other thienopyridines (5.5).

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-

272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: BLEEDING RISK

1 INDICATIONS AND USAGE

1.1 Acute Coronary Syndrome

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Active Bleeding

4.2 Prior Transient Ischemic Attack or Stroke

4.3 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 General Risk of Bleeding

5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding

5.3 Discontinuation of Effient

5.4 Thrombotic Thrombocytopenic Purpura

5.5 Hypersensitivity Including Angioedema

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Warfarin

7.2 Non-Steroidal Anti-Inflammatory Drugs

7.3 Other Concomitant Medications

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Low Body Weight

8.7 Renal Impairment

8.8 Hepatic Impairment

8.9 Metabolic Status

10 OVERDOSAGE

10.1 Signs and Symptoms

10.2 Recommendations about Specific Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

WARNING: BLEEDING RISK

1 INDICATIONS AND USAGE

1.1 Acute Coronary Syndrome

Prasugrel tablets 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:

Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death,

Sections or subsections omitted from the full prescribing information are not listed.

Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and

Precautions (5.1,5.2) and Adverse Reactions (6.1)].

Do not use Prasugrel tablets in patients with active pathological bleeding or a history

of transient ischemic attack or stroke [see Contraindications (4.1, 4.2)].

In patients ≥75 years of age, Prasugrel tablets 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 MI) where its effect

appears to be greater and its use may be considered [see Use in Specific Populations

(8.5)].

Do not start Prasugrel tablets in patients likely to undergo urgent coronary artery

bypass graft surgery (CABG). When possible, discontinue Prasugrel tablets at least 7

days prior to any surgery [see Warnings and Precautions (5.2)].

Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed;

concomitant use of medications that increase the risk of bleeding (e.g., warfarin,

heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs

[NSAIDs]) [see Warnings and Precautions (5.1)].

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 Prasugrel tablets [see Warnings and Precautions

(5.1)].

If possible, manage bleeding without discontinuing Prasugrel tablets. Discontinuing

Prasugrel tablets, particularly in the first few weeks after acute coronary syndrome,

increases the risk of subsequent cardiovascular events [see Warnings and Precautions

(5.3)].

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.

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 [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

Initiate Prasugrel tablets treatment as a single 60-mg oral loading dose and then continue at 10-mg orally

once daily. Patients taking Prasugrel tablets should also take aspirin (75-mg to 325-mg) daily [see Drug

Interactions (7.3) and Clinical Pharmacology (12.3)]. Prasugrel tablets may be administered with or

without food [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

Timing of Loading Dose

In the clinical trial that established the efficacy and safety of Prasugrel tablets, the loading dose of

Prasugrel tablets was not administered until coronary anatomy was established in UA/NSTEMI patients

and in STEMI patients presenting more than 12 hours after symptom onset. In STEMI patients presenting

within 12 hours of symptom onset, the loading dose of Prasugrel tablets was administered at the time of

diagnosis, although most received Prasugrel tablets at the time of PCI [see Clinical Studies (14)]. For the

small fraction of patients that required urgent CABG after treatment with Prasugrel tablets, the risk of

significant bleeding was substantial.

Although it is generally recommended that antiplatelet therapy be administered promptly in the

management of ACS because many cardiovascular events occur within hours of initial presentation, in a

trial of 4033 NSTEMI patients, no clear benefit was observed when Prasugrel tablets loading dose was

administered prior to diagnostic coronary angiography compared to at the time of PCI; however, risk of

bleeding was increased with early administration in patients undergoing PCI or early CABG.

Dosing in Low Weight Patients

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 [see Warnings and Precautions (5.1), Adverse

Reactions (6.1), and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Active Bleeding

Prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer

or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

4.2 Prior Transient Ischemic Attack or Stroke

Prasugrel tablets is contraindicated in patients with a history of prior transient ischemic attack (TIA) or

stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing

Platelet Inhibition with Prasugrel), patients with a history of TIA or ischemic stroke (>3 months prior to

enrollment) had a higher rate of stroke on Prasugrel tablets (6.5%; of which 4.2% were thrombotic

stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In

patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with

Prasugrel tablets 5-mg is available as a yellow, oval, biconvex, film-coated, non-scored tablet

debossed with “P5” on one side and plain on other side.

Prasugrel tablets 10-mg is available as a yellow, oval, biconvex, film-coated, non-scored tablet

debossed with “P1” on one side and plain on other side.

Prasugrel tablets and clopidogrel, respectively. Patients with a history of ischemic stroke within 3

months of screening and patients with a history of hemorrhagic stroke at any time were excluded from

TRITON-TIMI 38. Patients who experience a stroke or TIA while on Prasugrel tablets generally

should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)].

4.3 Hypersensitivity

Prasugrel tablets is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or

any component of the product [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 General Risk of Bleeding

Thienopyridines, including Prasugrel tablets, increase the risk of bleeding. With the dosing regimens

used in TRITON-TIMI 38, TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt

bleeding associated with a fall in hemoglobin ≥5 g/dL, or intracranial hemorrhage) and TIMI Minor

(overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL) bleeding events were more

common on Prasugrel tablets than on clopidogrel [see Adverse Reactions (6.1)]. The bleeding risk is

highest initially, as shown in Figure 1 (events through 450 days; inset shows events through 7 days)

Figure 1: Non-CABG-Related TIMI Major or Minor Bleeding Events

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography,

PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding.

Do not use Prasugrel tablets in patients with active bleeding, prior TIA or stroke [see Contraindications

(4.1, 4.2)].

Other risk factors for bleeding are:

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

5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding

The risk of bleeding is increased in patients receiving Prasugrel tablets who undergo CABG. If

possible, Prasugrel tablets should be discontinued at least 7 days prior to CABG.

Of the 437 patients who underwent CABG during TRITON-TIMI 38, the rates of CABG-related TIMI

Major or Minor bleeding were 14.1% in the Prasugrel tablets group and 4.5% in the clopidogrel group

[see Adverse Reactions (6.1)]. The higher risk for bleeding events in patients treated with Prasugrel

tablets persisted up to 7 days from the most recent dose of study drug. For patients receiving a

thienopyridine within 3 days prior to CABG, the frequencies of TIMI Major or Minor bleeding were

26.7% (12 of 45 patients) in the Prasugrel tablets group, compared with 5.0% (3 of 60 patients) in the

clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior

to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of

89 patients) in the clopidogrel group.

Do not start Prasugrel tablets in patients likely to undergo urgent CABG. CABG-related bleeding may

be treated with transfusion of blood products, including packed red blood cells and platelets; however,

platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less

effective.

5.3 Discontinuation of Effient

Discontinue thienopyridines, including Prasugrel tablets, for active bleeding, elective surgery, stroke,

or TIA. The optimal duration of thienopyridine therapy is unknown. In patients who are managed with

PCI and stent placement, premature discontinuation of any antiplatelet medication, including

thienopyridines, conveys an increased risk of stent thrombosis, myocardial infarction, and death. Patients

Age ≥75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain

effectiveness in patients ≥75 years of age, use of Prasugrel tablets is generally not recommended

in these patients, except in high-risk situations (patients with diabetes or history of myocardial

infarction) where its effect appears to be greater and its use may be considered [see Adverse

Reactions (6.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.3), and Clinical Trials

(14)].

CABG or other surgical procedure [see Warnings and Precautions (5.2)].

Body weight <60 kg. Consider a lower (5-mg) maintenance dose [see Dosage and Administration

(2), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].

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) [see Adverse Reactions (6.1) and Use in Specific Populations (8.7, 8.8)].

Medications that increase the risk of bleeding (e.g., oral anticoagulants, chronic use of non-

steroidal anti-inflammatory drugs [NSAIDs], and fibrinolytic agents). Aspirin and heparin were

commonly used in TRITON-TIMI 38 [see Drug Interactions (7.1,7.2,7.3), and Clinical Studies (14)].

who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events.

Lapses in therapy should be avoided, and if thienopyridines must be temporarily discontinued because

of an adverse event(s), they should be restarted as soon as possible [see Contraindications (4.1, 4.2) and

Warnings and Precautions (5.1)].

5.4 Thrombotic Thrombocytopenic Purpura

Thrombotic thrombocytopenic purpura (TTP) has been reported with the use of Prasugrel tablets. 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). TTP is characterized by

thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragment red blood cells] seen on

peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2)].

5.5 Hypersensitivity Including Angioedema

Hypersensitivity including angioedema has been reported in patients receiving Prasugrel tablets,

including patients with a history of hypersensitivity reaction to other thienopyridines [see

Contraindications (4.3) and Adverse Reactions (6.2)].

6 ADVERSE REACTIONS

The following serious adverse reactions are also discussed elsewhere in the labeling:

6.1 Clinical Trials Experience

Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-

TIMI 38, in which 6741 patients were treated with Prasugrel tablets (60-mg loading dose and 10-mg

once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients

were treated for more than 1 year). The population treated with Prasugrel tablets was 27 to 96 years of

age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive

aspirin. The dose of clopidogrel in this study was a 300-mg loading dose and 75-mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials cannot be directly compared with the rates observed in other clinical trials of

another drug and may not reflect the rates observed in practice.

Drug Discontinuation

The rate of study drug discontinuation because of adverse reactions was 7.2% for Prasugrel tablets and

6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug

discontinuation for both drugs (2.5% for Prasugrel tablets and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery -In TRITON-TIMI 38, overall rates of TIMI Major or Minor

bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were

significantly higher on Prasugrel tablets than on clopidogrel, as shown in Table 1

Table 1: Non-CABG-Related Bleeding (TRITON-TIMI 38)

Prasugrel tablets

(%)

(N=6741)

Clopidogrel

(%)

(N=6716)

Bleeding [see Boxed Warning and Warnings and Precautions (5.1, 5.2)]

Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4)]

Hypersensitivity Including Angioedema [see Warnings and Precautions (5.5)]

a

TIMI Major or Minor bleeding

TIMI Major bleeding

Life-threatening

Fatal

Symptomatic intracranial

hemorrhage (ICH)

Requiring inotropes

Requiring surgical intervention

Requiring transfusion (≥4 units)

TIMI Minor bleeding

Patients may be counted in more than one row.

See 5.1 for definition.

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. The bleeding rate is highest

initially, as shown in Figure 1 (inset: Days 0 to 7) [see Warnings and Precautions (5.1)].Bleeding by

Weight and Age - In TRITON-TIMI 38, non-CABG-related TIMI Major or Minor bleeding rates in

patients with the risk factors of age 75 years and weight <60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI

38)

Major/Minor

Fatal

Pras ugrel

tablets

(%)

Clopidogrel

(%)

Pras ugrel

tablets

(%)

Clopidogrel

(%)

Weight <60 kg (N=308

Prasugrel tablets, N=356

clopidogrel)

10.1

Weight 60 kg (N=6373

Prasugrel tablets, N=6299

clopidogrel)

Age <75 years (N=5850

Prasugrel tablets, N=5822

clopidogrel)

Age 75 years (N=891

Prasugrel tablets, N=894

clopidogrel)

10-mg Prasugrel tabletsa maintenance dose

75-mg clopidogrel maintenance dose

Bleeding Related to CABG -In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent

CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was

14.1% for the Prasugrel tablets group and 4.5% in the clopidogrel group (see Table 3). The higher risk

for bleeding adverse reactions in patients treated with Prasugrel tablets persisted up to 7 days from the

most recent dose of study drug

Table 3: CABG-Related Bleeding (TRITON-TIMI 38)

Prasugrel tablets (%)

(N=213)

Clopidogrel (%)

(N=224)

a

b

a

b

a

TIMI Major or Minor bleeding

14.1

TIMI Major bleeding

11.3

Fatal

Reoperation

Transfusion of ≥5 units

Intracranial hemorrhage

TIMI Minor bleeding

Patients may be counted in more than one row.

Bleeding Reported as Adverse Reactions - Hemorrhagic events reported as adverse reactions in

TRITON-TIMI 38 were, for Prasugrel tablets and clopidogrel, respectively: epistaxis (6.2%, 3.3%),

gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous hematoma (0.5%,

0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%),

pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies

During TRITON-TIMI 38, newly-diagnosed malignancies were reported in 1.6% and 1.2% of patients

treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were

primarily colon and lung. In another Phase 3 clinical study of ACS patients not undergoing PCI, in which

data for malignancies were prospectively collected, newly-diagnosed malignancies were reported in

1.8% and 1.7% of patients treated with prasugrel and clopidogrel, respectively. The site of

malignancies was balanced between treatment groups except for colorectal malignancies. The rates of

colorectal malignancies were 0.3% prasugrel, 0.1% clopidogrel and most were detected during

investigation of GI bleed or anemia. It is unclear if these observations are causally-related, are the

result of increased detection because of bleeding, or are random occurrences.

Other Adverse Events

In TRITON-TIMI 38, common and other important non-hemorrhagic adverse events were, for Prasugrel

tablets and clopidogrel, respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%),

abnormal hepatic function (0.22%, 0.27%), allergic reactions (0.36%, 0.36%), and angioedema (0.06%,

0.04%). Table 4 summarizes the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of

Patients in Either Group

Prasugrel tablets (%)

(N=6741)

Clopidogrel (%)

(N=6716)

Hypertension

Hypercholesterolemia/Hyperlipidemia

Headache

Back pain

Dyspnea

Nausea

Dizziness

Cough

Hypotension

Fatigue

Non-cardiac chest pain

Atrial fibrillation

Bradycardia

Leukopenia (<4 x 109 WBC/L)

Rash

Pyrexia

Peripheral edema

Pain in extremity

Diarrhea

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Prasugrel tablets.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always

possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders — Thrombocytopenia, Thrombotic thrombocytopenic purpura

(TTP) [see Warnings and Precautions (5.4) and Patient Counseling Information (17)]

Immune system disorders — Hypersensitivity reactions including anaphylaxis [see Contraindications

(4.3)]

7 DRUG INTERACTIONS

7.1 Warfarin

Coadministration of Prasugrel tablets and warfarin increases the risk of bleeding [see Warnings and

Precautions (5.1) and Clinical Pharmacology (12.3)].

7.2 Non-Steroidal Anti-Inflammatory Drugs

Coadministration of Prasugrel tablets and NSAIDs (used chronically) may increase the risk of bleeding

[see Warnings and Precautions (5.1)].

7.3 Other Concomitant Medications

Prasugrel tablets can be administered with drugs that are inducers or inhibitors of cytochrome P450

enzymes [see Clinical Pharmacology (12.3)].

Prasugrel tablets can be administered with aspirin (75-mg to 325-mg per day), heparin, GPIIb/IIIa

inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2

blockers [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. No

structural malformations were observed in animal reproductive and developmental toxicology studies

when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the

recommended therapeutic exposures in humans [see Data]. Due to the mechanism of action of prasugrel

tablets, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel

tablets and possible risks to the fetus when prescribing prasugrel tablets to a pregnant woman [see Boxed

Warning, and Warnings and Precautions (5.1, 5.3)].

The background risk of major birth defects and miscarriage for the indicated population is unknown.

The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is

15-20% of clinically recognized pregnancies.

Data

Animal Data

In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at

maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in

fetal body weight was observed; but, there were no structural malformations in either species. In

prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or

reproductive development of the offspring at doses greater than 150 times the human exposure.

8.2 Lactation

Risk Summary

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 [see Data]. The

developmental and health benefits of breastfeeding should be considered along with the mother’s

clinical need for Prasugrel tablets and any potential adverse effects on the breastfed child from

Prasugrel tablets or from the underlying maternal condition.

Data

Animal Data

Following a 5-mg/kg oral dose of [

C]-prasugrel to lactating rats, metabolites of prasugrel were

detected in the maternal milk and blood.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Information describing a pediatric clinical study in another indication in which efficacy was not

demonstrated in patients is approved for Eli Lilly and Company’s Effient® (prasugrel) tablets. However, due

to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric

information.

8.5 Geriatric Use

In TRITON-TIMI 38, 38.5% of patients were ≥65 years of age and 13.2% were ≥75 years of age. The

risk of bleeding increased with advancing age in both treatment groups, although the relative risk of

bleeding (Prasugrel tablets compared with clopidogrel) was similar across age groups.

Patients ≥75 years of age who received Prasugrel tablets 10-mg had an increased risk of fatal bleeding

events (1.0%) compared to patients who received clopidogrel (0.1%). In patients ≥75 years of age,

symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received Prasugrel tablets and

in 3 patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because

effectiveness is uncertain in patients ≥75 years of age [see Clinical Studies (14)], use of Prasugrel tablets

is generally not recommended in these patients, except in high-risk situations (diabetes and past history

of myocardial infarction) where its effect appears to be greater and its use may be considered [see

Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

8.6 Low Body Weight

In TRITON-TIMI 38, 4.6% of patients treated with Prasugrel tablets had body weight <60 kg.

Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the

active metabolite of prasugrel [see Dosage and Administration (2), Warnings and Precautions (5.1), and

Clinical Pharmacology (12.3)]. 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. [see Dosage and

Administration (2) and Clinical Pharmacology (12.3)].

8.7 Renal Impairment

No dosage adjustment is necessary for patients with renal impairment. There is limited experience in

patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see

Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

8.8 Hepatic Impairment

No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh

Class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in patients with severe

hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see

Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

8.9 Metabolic Status

In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel,

there was no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or CYP3A5 on the

pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation.

10 OVERDOSAGE

10.1 Signs and Symptoms

Platelet inhibition by prasugrel is rapid and irreversible, lasting for the life of the platelet, and is

unlikely to be increased in the event of an overdose. In rats, lethality was observed after administration

of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline

phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis,

irregular respiration, decreased locomotor activity, ptosis, staggering gait, and lacrimation.

10.2 Recommendations about Specific Treatment

Platelet transfusion may restore clotting ability. The prasugrel active metabolite is not likely to be

removed by dialysis.

11 DESCRIPTION

Prasugrel tablets contains prasugrel, a thienopyridine class inhibitor of platelet activation and

aggregation mediated by the P2Y12 ADP receptor. Prasugrel tablets is formulated as the hydrochloride

salt, a racemate, which is chemically designated as 5[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-

oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride

has the empirical formula C

H FNO SHCl representing a molecular weight of 409.90. The

chemical structure of prasugrel hydrochloride is:

Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at

pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly

soluble in 1-and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate.

Prasugrel tablet is available for oral administration as 5-mg or 10-mg oval, biconvex, film-coated, non-

scored tablets, debossed on one side and plain on other side. Each yellow 5-mg tablet is manufactured

with 5.49 mg prasugrel hydrochloride, equivalent to 5-mg prasugrel and each yellow 10-mg tablet with

10.98 mg prasugrel hydrochloride, equivalent to 10-mg of prasugrel.

Other ingredients include mannitol, hypromellose, stearic acid, microcrystalline cellulose, Glyceryl

behenate and low substituted hydroxypropyl cellulose. The color coatings contain lactose monohydrate,

hypromellose, titanium dioxide, triacetin and iron (Ferric) oxide yellow.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its

active metabolite to the P2Y class of ADP receptors on platelets.

12.2 Pharmacodynamics

Prasugrel produces inhibition of platelet aggregation to 20 µM or 5 µM ADP, as measured by light

transmission aggregometry. Following a 60-mg loading dose of Prasugrel tablets, approximately 90%

of patients had at least 50% inhibition of platelet aggregation by 1 hour. Maximum platelet inhibition

was about 80% (see Figure 2). Mean steady-state inhibition of platelet aggregation was about 70%

following 3 to 5 days of dosing at 10-mg daily after a 60-mg loading dose of Prasugrel tablets.

Figure 2: Inhibition (Mean±SD) of 20 µM ADP-induced Platelet Aggregation (IPA) Measured by

Light Transmission Aggregometry after Prasugrel 60-mg.

Platelet aggregation gradually returns to baseline values over 5-9 days after discontinuation of

prasugrel, this time course being a reflection of new platelet production rather than pharmacokinetics of

prasugrel. Discontinuing clopidogrel 75-mg and initiating a prasugrel 10-mg maintenance dose with or

without a prasugrel 60-mg loading dose results in a decrease of 14 percentage points in maximum

platelet aggregation (MPA) by Day 7. This decrease in MPA is not greater than that typically produced

by a 10-mg maintenance dose of prasugrel alone. The relationship between inhibition of platelet

aggregation and clinical activity has not been established.

5-mg in Low Body Weight Patients -In patients with stable coronary artery disease, mean platelet

inhibition in subjects <60 kg taking 5-mg prasugrel was similar to that of subjects ≥60 kg taking 10-mg

prasugrel. The relationship between inhibition of platelet aggregation and clinical activity has not been

established

12.3 Pharmacokinetics

Prasugrel is a prodrug and is rapidly metabolized to a pharmacologically active metabolite and inactive

metabolites. The active metabolite has an elimination half-life of about 7 hours (range 2-15 hours).

Healthy subjects, patients with stable atherosclerosis, and patients undergoing PCI show similar

pharmacokinetics.

Absorption and Binding - Following oral administration, ≥79% of the dose is absorbed. The absorption

and metabolism are rapid, with peak plasma concentrations (Cmax) of the active metabolite occurring

approximately 30 minutes after dosing. The active metabolite's exposure (AUC) increases slightly more

than proportionally over the dose range of 5 to 60-mg. Repeated daily doses of 10-mg do not lead to

accumulation of the active metabolite. In a study of healthy subjects given a single 15-mg dose, the

AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased

by 49% and Tmax was increased from 0.5 to 1.5 hours. Prasugrel tablets can be administered without

regard to food. The active metabolite is bound about 98% to human serum albumin.

Metabolism and Elimination - Prasugrel is not detected in plasma following oral administration. It is

rapidly hydrolyzed in the intestine to a thiolactone, which is then converted to the active metabolite by a

single step, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19. The

estimates of apparent volume of distribution of prasugrel's active metabolite ranged from 44 to 68 L and

the estimates of apparent clearance ranged from 112 to 166 L/hr in healthy subjects and patients with

stable atherosclerosis. The active metabolite is metabolized to two inactive compounds by S-

methylation or conjugation with cysteine. The major inactive metabolites are highly bound to human

plasma proteins. Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the feces

as inactive metabolites.

Specific Populations

Geriatric - In a study of 32 healthy subjects between the ages of 20 and 80 years, age had no significant

effect on pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation. In

TRITON-TIMI 38, the mean exposure (AUC) of the active metabolite was 19% higher in patients ≥75

years of age than in patients <75 years of age. In a study in subjects with stable atherosclerosis, the

mean exposure (AUC) to the active metabolite of prasugrel in subjects ≥75 years old taking a 5-mg

maintenance dose was approximately half that seen in subjects 45 to 64 years old taking a 10-mg

maintenance dose. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].

Body Weight - The mean exposure (AUC) to the active metabolite is approximately 30 to 40% higher in

subjects with a body weight of <60 kg than in those weighing ≥60 kg. In a study in subjects with stable

atherosclerosis, the AUC of the active metabolite on average was 38% lower in subjects <60 kg taking

5-mg (N=34) than in subjects ≥60 kg taking 10-mg (N=38) [see Dosage and Administration (2), Warnings

and Precautions (5.1), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].

Gender -Pharmacokinetics of prasugrel's active metabolite are similar in men and women.

Ethnicity -Exposure in subjects of African and Hispanic descent is similar to that in Caucasians. In

clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was

approximately 19% higher in Chinese, Japanese, and Korean subjects than in Caucasian subjects.

Smoking -Pharmacokinetics of prasugrel's active metabolite are similar in smokers and nonsmokers.

Renal Impairment - Pharmacokinetics of prasugrel's active metabolite and its inhibition of platelet

aggregation are similar in patients with moderate renal impairment (CrCL=30 to 50 mL/min) and healthy

subjects. In patients with end-stage renal disease, exposure

to the active metabolite (both Cmax and AUC (0-tlast)) was about half that in healthy controls and

patients with moderate renal impairment [see Warnings and Precautions (5.1) and Use in Specific

patients with moderate renal impairment [see Warnings and Precautions (5.1) and Use in Specific

Populations (8.7)].

Hepatic Impairment - Pharmacokinetics of prasugrel's active metabolite and inhibition of platelet

aggregation were similar in patients with mild to moderate hepatic impairment compared to healthy

subjects. The pharmacokinetics and pharmacodynamics of prasugrel's

active metabolite in patients with severe hepatic disease have not been studied [see Warnings and

Precautions (5.1) and Use in Specific Populations (8.8)].

Drug Interactions

Potential for Other Drugs to Affect Prasugrel

Inhibitors of CYP3A - Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and

CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the active metabolite's

AUC and Tmax, but decreased the Cmax by 34% to 46%. Therefore, CYP3A inhibitors such as

verapamil, diltiazem, indinavir, ciprofloxacin, clarithromycin, and grapefruit juice are not expected to

have a significant effect on the pharmacokinetics of the active metabolite of prasugrel [see Drug

Interactions (7.3)].

Inducers of Cytochromes P450 - Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6 and

an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of

prasugrel's active metabolite or its inhibition of platelet aggregation. Therefore, known CYP3A

inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not expected

to have significant effect on the pharmacokinetics of the active metabolite of prasugrel [see Drug

Interactions (7.3)].

Drugs that Elevate Gastric pH - Daily coadministration of ranitidine (an H2 blocker) or lansoprazole (a

proton pump inhibitor) decreased the Cmax of the prasugrel active metabolite by 14% and 29%,

respectively, but did not change the active metabolite's AUC and Tmax. In TRITON-TIMI 38, Prasugrel

tablets was administered without regard to coadministration of a proton pump inhibitor or H2 blocker

[see Drug Interactions (7.3)].

Statins - Atorvastatin (80 mg daily), a drug metabolized by CYP450 3A4, did not alter the

pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation [see Drug

Interactions (7.3)].

Heparin - A single intravenous dose of unfractionated heparin (100 U/kg) did not significantly alter

coagulation or the prasugrel-mediated inhibition of platelet aggregation; however, bleeding time was

increased compared with either drug alone [see Drug Interactions (7.3)].

Aspirin - Aspirin 150 mg daily did not alter prasugrel-mediated inhibition of platelet aggregation;

however, bleeding time was increased compared with either drug alone [see Drug Interactions (7.3)].

Warfarin - A significant prolongation of the bleeding time was observed when prasugrel was

coadministered with 15-mg of warfarin [see Drug Interactions (7.1)].

Potential for Prasugrel to Affect Other Drugs

In vitro metabolism studies demonstrate that prasugrel's main circulating metabolites are not likely to

cause clinically significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A, or

induction of CYP1A2 or CYP3A.

Drugs Metabolized by CYP2B6 — Prasugrel is a weak inhibitor of CYP2B6. In healthy subjects,

prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by

23%, an amount not considered clinically significant. Prasugrel is not anticipated to have significant

effect on the pharmacokinetics of drugs that are primarily metabolized by CYP2B6, such as halothane,

cyclophosphamide, propofol, and nevirapine.

Effect on Digoxin - The potential role of prasugrel as a Pgp substrate was not evaluated. Prasugrel is not

an inhibitor of Pgp, as digoxin clearance was not affected by prasugrel coadministration [see Drug

Interactions (7.3)].

Interactions (7.3)].

12.5 Pharmacogenomics

There is no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or CYP3A5 on the

pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis -No compound-related tumors were observed in a 2-year rat study with prasugrel at oral

doses up to 100 mg/kg/ day (>100 times the recommended therapeutic exposures in humans (based on

plasma exposures to the major circulating human metabolite). There was an increased incidence of

tumors (hepatocellular adenomas) in mice exposed for 2 years to high doses (>250 times the human

metabolite exposure).

Mutagenesis - Prasugrel was not genotoxic in two in vitro tests (Ames bacterial gene mutation test,

clastogenicity assay in Chinese hamster fibroblasts) and in one in vivo test (micronucleus test by

intraperitoneal route in mice).

Impairment of Fertility - Prasugrel had no effect on fertility of male and female rats at oral doses up to

300 mg/kg/day (80 times the human major metabolite exposure at daily dose of 10-mg prasugrel).

14 CLINICAL STUDIES

The clinical evidence for the effectiveness of Prasugrel tablets is derived from the TRITON-TIMI 38

(Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with

Prasugrel) study, a 13,608-patient, multicenter, international, randomized, double-blind, parallel-group

study comparing Prasugrel tablets to a regimen of clopidogrel, each added to aspirin and other standard

therapy, in patients with ACS (UA, NSTEMI, or STEMI) who were to be managed with PCI.

Randomization was stratified for UA/NSTEMI and STEMI.

Patients with UA/NSTEMI presenting within 72 hours of symptom onset were to be randomized after

undergoing coronary angiography. Patients with STEMI presenting within 12 hours of symptom onset

could be randomized prior to coronary angiography. Patients with STEMI presenting between 12 hours

and 14 days of symptom onset were to be randomized after undergoing coronary angiography. Patients

underwent PCI, and for both UA/NSTEMI and STEMI patients, the loading dose was to be administered

anytime between randomization and 1 hour after the patient left the catheterization lab. If patients with

STEMI were treated with thrombolytic therapy, randomization could not occur until at least 24 hours

(for tenecteplase, reteplase, or alteplase) or 48 hours (for streptokinase) after the thrombolytic was

given.

Patients were randomized to receive Prasugrel tablets (60-mg loading dose followed by 10-mg once

daily) or clopidogrel (300-mg loading dose followed by 75-mg once daily), with administration and

follow-up for a minimum of 6 months (actual median 14.5 months). Patients also received aspirin (75-mg

to 325-mg once daily). Other therapies, such as heparin and intravenous glycoprotein IIb/IIIa (GPIIb/IIIa)

inhibitors, were administered at the discretion of the treating physician. Oral anticoagulants, other

platelet inhibitors, and chronic NSAIDs were not allowed.

The primary outcome measure was the composite of cardiovascular death, nonfatal MI, or nonfatal

stroke in the UA/NSTEMI population. Success in this group allowed analysis of the same endpoint in

the overall ACS and STEMI populations. Nonfatal MIs included both MIs detected solely through

analysis of creatine kinase muscle-brain (CK-MB) changes and clinically apparent (investigator-

reported) MIs.

The patient population was 92% Caucasian, 26% female, and 39% 65 years of age. The median time

from symptom onset to study drug administration was 7 hours for patients with STEMI and 30 hours for

patients with UA/NSTEMI. Approximately 99% of patients underwent PCI. The study drug was

administered after the first coronary guidewire was placed in approximately 75% of patients.

Prasugrel tablets significantly reduced total endpoint events compared to clopidogrel (see Table 5 and

Figure 3). The reduction of total endpoint events was driven primarily by a decrease in nonfatal MIs,

both those occurring early (through 3 days) and later (after 3 days). Approximately 40% of MIs

occurred peri-procedurally and were detected solely by changes in CK-MB. Administration of the

clopidogrel loading dose in TRITON-TIMI 38 was delayed relative to the placebo-controlled trials

that supported its approval for ACS. Prasugrel tablets produced higher rates of clinically significant

bleeding than clopidogrel in TRITON-TIMI 38 [see Adverse Reactions (6.1)]. Choice of therapy

requires balancing these differences in outcome.

The treatment effect of Prasugrel tablets was apparent within the first few days, and persisted to the end

of the study (see Figure 3). The inset shows results over the first 7 days.

Figure 3: Time to first event of CV death, MI, or stroke (TRITON-TIMI 38).

The Kaplan-Meier curves (see Figure 3) show the primary composite endpoint of CV death, nonfatal

MI, or nonfatal stroke over time in the UA/NSTEMI and STEMI populations. In both populations, the

curves separate within the first few hours. In the UA/NSTEMI population, the curves continue to

diverge throughout the 15 month follow-up period. In the STEMI population, the early separation was

maintained throughout the 15 month follow-up period, but there was no progressive divergence after

the first few weeks.

Prasugrel tablets reduced the occurrence of the primary composite endpoint compared to clopidogrel in

both the UA/NSTEMI and STEMI populations (see Table 5). In patients who survived an on-study

myocardial infarction, the incidence of subsequent events was also lower in the Prasugrel tablets group.

Table 5: Patients with Outcome Events (CV Death, MI, Stroke) in TRITON-TIMI 38

Patients with

events

From Kaplan-

Meier analysis

Prasugrel tablets

(%)

Clopidogrel

(%)

Relative Risk

Reduction (%)

(95% CI)

p-value

UA/NSTEMI

N=5044

N=5030

CV death, nonfatal

MI, or nonfatal

stroke

11.2

18.0 (7.3, 27.4)

0.002

CV death

2.1 (-30.9, 26.8)

0.885

Nonfatal MI

23.9 (12.7, 33.7)

<0.001

Nonfatal Stroke

2.1 (-51.3, 36.7)

0.922

STEMI

N=1769

N=1765

CV death, nonfatal

MI, or nonfatal

stroke

12.2

20.7 (3.2, 35.1)

0.019

CV death

26.2 (-9.4, 50.3)

0.129

Nonfatal MI

25.4 (5.2, 41.2)

0.016

Nonfatal Stroke

-9.7 (-104.0, 41.0)

0.77

RRR = (1-Hazard Ratio) x 100%. Values with a negative relative risk reduction indicate a relative risk

increase.

The effect of Prasugrel tablets in various subgroups is shown in Figures 4 and 5. Results are generally

consistent across pre-specified subgroups, with the exception of patients with a history of TIA or

stroke [see Contraindications (4.2)]. The treatment effect was driven primarily by a reduction in nonfatal

MI. The effect in patients 75 years of age was also somewhat smaller, and bleeding risk is higher in

these individuals [see Adverse Reactions (6.1)]. See below for analyses of patients 75 years of age with

risk factors.

Figure 4: Subgroup analyses for time to first event of CV death, MI, or stroke (HR and 95% CI;

TRITON-TIMI 38) UA/NSTEMI Patients.

a

Figure 5: Subgroup analyses for time to first event of CV death, MI, or stroke (HR and 95% CI;

TRITONTIMI38) STEMI Patients.

Prasugrel tablets is generally not recommended in patients 75 years of age, except in high-risk

situations (diabetes mellitus or prior MI) where its effect appears to be greater and its use may be

considered. These recommendations are based on subgroup analyses (see Table 6) and must be

interpreted with caution, but the data suggest that Prasugrel tablets reduces ischemic events in such

patients.

Table 6: Subgroup Analyses for Time to First Event of CV Death, MI, or Stroke: Patients < or

≥75 Years of Age, ± Diabetes, ± Prior History of MI, All ACS Patient Population

Prasugrel

tablets

Clopidogrel

N

% with events

N

% with events

Hazard Ratio

(95% Cl)

Age ≥75

Diabetes – yes

14.9

21.8

0.64 (0.42,

0.97)

Diabetes - no

16.4

15.3

1.1 (0.83,

1.43)

Age <75

Diabetes – yes

1327

10.8

1336

14.8

0.72 (0.58,

0.89)

Diabetes - no

4585

4551

0.82 (0.71,

0.94)

Age ≥75

Prior MI - yes

17.3

22.6

0.72 (0.47,

1.09)

Prior MI - no

15.6

15.2

1.05 (0.80,

1.37)

Age <75

Prior MI - yes

1006

12.2

15.4

0.78 (0.62,

0.99)

Prior MI - no

4906

4891

0.78 (0.68,

0.90)

There were 50% fewer stent thromboses (95% C.I. 32% -64%; p<0.001) reported among patients

randomized to Prasugrel tablets (0.9%) than among patients randomized to clopidogrel (1.8%). The

difference manifested early and was maintained through one year of follow-up. Findings were similar

with bare metal and drug-eluting stents.

In TRITON-TIMI 38, prasugrel reduced ischemic events (mainly nonfatal MIs) and increased bleeding

events [see Adverse Reactions (6.1)] relative to clopidogrel. The findings are consistent with the

intended greater inhibition of platelet aggregation by prasugrel at the doses used in the study [see

Clinical Pharmacology (12.2)]. There is, however, an alternative explanation: both prasugrel and

clopidogrel are pro-drugs that must be metabolized to their active moieties. Whereas the

pharmacokinetics of prasugrel's active metabolite are not known to be affected by genetic variations in

CYP2B6, CYP2C9, CYP2C19, or CYP3A5, the pharmacokinetics of clopidogrel's active metabolite are

affected by CYP2C19 genotype, and approximately 30% of Caucasians are reduced-metabolizers.

Moreover, certain proton pump inhibitors, widely used in the ACS patient population and used in

TRITON-TIMI 38, inhibit CYP2C19, thereby decreasing formation of clopidogrel's active metabolite.

Thus, reduced-metabolizer status and use of proton pump inhibitors may diminish clopidogrel's activity

in a fraction of the population, and may have contributed to prasugrel's greater treatment effect and

greater bleeding rate in TRITON-TIMI 38. The extent to which these factors were operational,

however, is unknown.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Prasugrel tablets is available as oval, biconvex, film coated tablets, non-scored tablets in the following

strengths, colors, deboss, and presentations:

Feature

Strengths

5 mg

10 mg

Tablet color

Yellow

Yellow

Tablet debossed

Presentation and NDC Codes

Bottles of 30

0440-0604-30

0440-0605-30

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room

Temperature].

Dispense and keep product in original container. Keep container closed and do not remove desiccant

from bottle. Do not break the tablet.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide)

Benefits and Risks

Summarize the effectiveness features and potential side effects of Prasugrel tablets.

Tell patients to take Prasugrel tablets exactly as prescribed.

Remind patients not to discontinue Prasugrel tablets without first discussing it with the physician who

prescribed Prasugrel tablets.

Recommend that patients read the Medication Guide

Bleeding

Inform patients that they:

will bruise and bleed more easily.

will take longer than usual to stop bleeding.

should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine.

Other Signs and Symptoms Requiring Medical Attention

Inform patients that TTP is a rare but serious condition that has been reported with Prasugrel tablets.

Instruct patients to get prompt medical attention if they experience any of the following symptoms that

cannot otherwise be explained: fever, weakness, extreme skin paleness, purple skin patches, yellowing

of the skin or eyes, or neurological changes.

Inform patients that they may have hypersensitivity reactions including rash, angioedema, anaphylaxis,

or other manifestations. Patients who have had hypersensitivity reactions to other thienopyridines may

have hypersensitivity reactions to Prasugrel tablets.

Invasive Procedures

Instruct patients to:

inform physicians and dentists that they are taking Prasugrel tablets before any invasive procedure is

scheduled.

tell the doctor performing the invasive procedure to talk to the prescribing health care professional

before stopping Prasugrel tablets.

Concomitant Medications

Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements

Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements

they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk

(e.g., warfarin and NSAIDs).

Manufactured by:

Windlas Healthcare (P) Ltd.

Plot No.: 183 & 192, Mohabewala industrial Area,

Dehradun-248110, Uttarakhand-INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: 10/2017

MEDICATION GUIDE

Prasugrel (PRA-soo-grel) tablets

Read this Medication Guide before you start taking Prasugrel tablets and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking with your

doctor about your medical condition or your treatment.

What is the most important information I should know about Prasugrel tablets?

Prasugrel tablets is used to lower your chance of having a heart attack or other serious problems with

your heart or blood vessels. But, Prasugrel tablets can cause bleeding, which can be serious, and

sometimes lead to death. You should not start to take Prasugrel tablets if it is likely that you will have

heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher

risk of bleeding if you take Prasugrel tablets and then have heart bypass surgery.

Do not take Prasugrel tablets if you:

currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head

have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)

are allergic to prasugrel or any of the ingredients in Prasugrel tablets. See the end of this Medication

Guide for a list of ingredients in Prasugrel tablets.

Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you

may be having a stroke or TIA include:

sudden slurring of speech,

sudden weakness or numbness in one part of your body,

sudden blurry vision, or sudden severe headache.

If you have a stroke or TIA while taking Prasugrel tablets, your doctor will probably stop your

Prasugrel tablets. Follow your doctor's instructions about stopping Prasugrel tablets. Do not

stop taking Prasugrel tablets unless your doctor tells you to.

Before having any surgery you should talk to your doctor about stopping Prasugrel tablets. If

possible, Prasugrel tablets should be stopped at least 1 week (7 days) before any surgery, as

instructed by the doctor who prescribed Prasugrel tablets for you.

Your risk of bleeding while taking Prasugrel tablets may be higher if you also:

have had trauma, such as an accident or surgery

have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer

have severe liver problems

have moderate to severe kidney problems

weigh less than 132 pounds

take other medicines that increase your risk of bleeding, including:

warfarin sodium (Coumadin*, Jantoven*)

a medicine that contains heparin

other medicines to prevent or treat blood clots

regular daily use of non-steroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your

medicine is one listed above.

Prasugrel tablets increases your risk of bleeding because it lessens the ability of your blood to clot.

While you take Prasugrel tablets:

you will bruise and bleed more easily

you are more likely to have nose bleeds

it will take longer for any bleeding to stop

Call your doctor right away if you have any of these signs or symptoms of bleeding:

unexpected bleeding or bleeding that lasts a long time

bleeding that is severe or you cannot control

pink or brown urine

red or black stool (looks like tar)

bruises that happen without a known cause or get larger

cough up blood or blood clots

vomit blood or your vomit looks like “coffee grounds”

Do not stop taking Prasugrel tablets without talking to the doctor who prescribes it for you.

People who are treated with angioplasty and have a stent, and stop taking Prasugrel tablets too

soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must

stop Prasugrel tablets because of bleeding, your risk of a heart attack may be higher. See “What

are the possible side effects of Prasugrel tablets?” for more information about side effects.

What is Prasugrel tablets?

Prasugrel tablets is a prescription medicine used to treat people who:

have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen,

have been treated with a procedure called “angioplasty” (also called balloon angioplasty).

Prasugrel tablets is used to lower your chance of having another serious problem with your heart or

blood vessels, such as another heart attack, a stroke, blood clots in your stent, or death.

Platelets are blood cells that help with normal blood clotting. Prasugrel tablets helps prevent platelets

from sticking together and forming a clot that can block an artery or a stent.

It is not known if Prasugrel tablets is safe and works in children.

What should I tell my doctor before taking Prasugrel tablets?

Prasugrel tablets may not be right for you. Tell your doctor about all of your medical conditions,

including if you:

have any bleeding problems

have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)

are allergic to any medicines, including clopidogrel (Plavix*) or ticlopidine hydrochloride (Ticlid*)

have a history of stomach ulcers, colon polyps, diverticulosis

have liver problems

have kidney problems

have had any recent severe injury or surgery

plan to have surgery or a dental procedure. See “What is the most important information I should know

about Prasugrel tablets?”

pregnant, or are planning to get pregnant. It is not known if Prasugrel tablets will harm your baby.

if you are breast-feeding. It is not known if Prasugrel passes into your breast-milk. You and your

doctor should decide if you will take Prasugrel tablets or breast-feed. You should not do both without

talking with your doctor.

Tell all of your doctors and dentists that you are taking Prasugrel tablets. They should talk to the doctor

who prescribed Prasugrel tablets for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription

medicines, vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. See

“What is the most important information I should know about Prasugrel tablets?”

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you

get a new medicine.

How should I take Prasugrel tablets?

Take Prasugrel tablets exactly as prescribed by your doctor.

Take Prasugrel tablets one time each day.

You can take Prasugrel tablets with or without food.

Take Prasugrel tablets with aspirin as instructed by your doctor.

Your doctor will decide how long you should take Prasugrel tablets. Do not stop taking Prasugrel

tablets without first talking to the doctor who prescribed it for you. See “What is the most important

information I should know about Prasugrel tablets?”

If you miss a dose, take Prasugrel tablets as soon as you remember. If it is almost time for your next

dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the

same time unless your doctor tells you to.

If you take too much Prasugrel tablets, call your local emergency room or poison control center right

away.

Call your doctor or healthcare provider right away if you fall or injure yourself, especially if you hit

your head. Your doctor or healthcare provider may need to check you.

What are the possible side effects of Prasugrel tablets?

Prasugrel tablets can cause serious side effects, including:

See “What is the most important information I should know about Prasugrel tablets?”

A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen

with Prasugrel tablets, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem

where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a

hospital right away, because you may die. Get medical help right away if you have any of these

symptoms and they cannot be explained by another medical condition:

purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to

bleeding under the skin

paleness or jaundice (a yellowish color of the skin or eyes)

feeling tired or weak

fever

fast heart rate or feeling short of breath

headache, speech changes, confusion, coma, stroke, or seizure

low amount of urine or urine that is pink-tinged or has blood in it

stomach area (abdominal) pain, nausea, vomiting, or diarrhea

visual changes

Serious allergic reactions. Serious allergic reactions can happen with Prasugrel tablets, or if you

have had a serious allergic reaction to the medicine clopidogrel (Plavix*) or ticlopidine (Ticlid*). Get

medical help right away if you get any of these symptoms of a severe allergic reaction while

taking Prasugrel tablets.

swelling or hives of your face, lips, in or around your mouth, or throat

trouble breathing or swallowing

chest pain or pressure

dizziness or fainting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Prasugrel tablets. For more information, ask your

doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.

How should I store Prasugrel tablets?

Keep Prasugrel tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Prasugrel tablets in the container it comes in.

Keep the container closed tightly with the gray cylinder inside.

Protect Prasugrel tablets from moisture.

Keep Prasugrel tablets and all medicines out of the reach of children.

General Information about Prasugrel tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use Prasugrel tablets for a condition for which it was not prescribed. Do not give your Prasugrel

tablets to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Prasugrel tablets. If you would

like more information about Prasugrel tablets, talk with your doctor or pharmacist. For more

information, call 877-272-7901.

What are the ingredients in Prasugrel tablets?

Active Ingredient: prasugrel

Inactive Ingredients: mannitol, hypromellose, stearic acid, microcrystalline cellulose, Glyceryl

behenate and low substituted hydroxypropyl cellulose.

The color coatings contain lactose monohydrate, hypromellose, titanium dioxide, triacetin and iron

(Ferric) oxide yellow.

Trademarks are the property of their respective owners.

Manufactured by:

Windlas Healthcare (P) Ltd.

Plot No.: 183 & 192, Mohabewala Industrial Area,

Dehradun-248110, Uttarakhand-INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: 10/2017

PACKAGE LABEL – Prasugrel Tablets 5 mg

30 Tablets

NDC 0440-0604-30

Prasugrel tablets

5 mg

Rx only

Dispense and keep only in original container. Keep container closed and do not remove desiccant

from bottle.

Dispense accompanying Medication Guide to each patient.

PACKAGE LABEL – Prasugrel Tablets 10 mg

30 Tablets

NDC 0440-0605-30

Prasugrel tablets

10 mg

Rx only

Dispense and keep only in original container. Keep container closed and do not remove desiccant

from bottle.

Dispense accompanying Medication Guide to each patient.

PRASUGREL

prasugrel tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 440 -0 6 0 4(NDC:6 78 77-6 0 4)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRASUGREL HYDRO CHLO RIDE (UNII: G8 9 JQ59 I13) (PRASUGREL - UNII:34K6 6 TBT9 9 )

PRASUGREL

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

GLYCERYL BEHENATE/EICO SADIO ATE (UNII: 73CJJ317SR)

LO W-SUBSTITUTED HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 216 5RE0 K14)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

HYPRO MELLO SE 2 9 10 ( 15 MPA.S) (UNII: 36 SFW2JZ0 W)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

OVAL

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 440 -0 6 0 4-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 579 0

10 /17/20 17

PRASUGREL

prasugrel tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 440 -0 6 0 5(NDC:6 78 77-6 0 5)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRASUGREL HYDRO CHLO RIDE (UNII: G8 9 JQ59 I13) (PRASUGREL - UNII:34K6 6 TBT9 9 )

PRASUGREL

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Liberty Pharmaceuticals, Inc.

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

GLYCERYL BEHENATE/EICO SADIO ATE (UNII: 73CJJ317SR)

LO W-SUBSTITUTED HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 216 5RE0 K14)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

HYPRO MELLO SE 2 9 10 ( 15 MPA.S) (UNII: 36 SFW2JZ0 W)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 440 -0 6 0 5-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 579 0

10 /17/20 17

Labeler -

Liberty Pharmaceuticals, Inc. (012568840)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro ficient Rx LP

0 79 50 2574

RELABEL(0 440 -0 6 0 4, 0 440 -0 6 0 5)

Revised: 8/2019

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