Effient (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Effient (prasugrel) 10 mg is supplied as a beige, elongated hexagonal, film-coated, non-scored tablet debossed with “10 MG” on one side and “4759” on the other side.
Bottles of 30NDC 54868-6238-0

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

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 Medication Guide

17.1 Benefits and Risks

  • Summarize the effectiveness features and potential side effects of Effient.
  • Tell patients to take Effient exactly as prescribed.
  • Remind patients not to discontinue Effient without first discussing it with the physician who prescribed Effient.
  • Recommend that patients read the Medication Guide.

17.2 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.

17.3 Other Signs and Symptoms Requiring Medical Attention

  • Inform patients that TTP is a rare but serious condition that has been reported with Effient.
  • 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.

17.4 Invasive Procedures

Instruct patients to:

  • inform physicians and dentists that they are taking Effient before any invasive procedure is scheduled.
  • tell the doctor performing the invasive procedure to talk to the prescribing health care professional before stopping Effient.

17.5 Concomitant Medications

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).

Literature Revised: December 6, 2010

Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285

Marketed by Daiichi Sankyo, Inc. and Eli Lilly and Company

Copyright ©2009, 2010, Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

PV 7311 AMP

Relabeling of “Additional barcode label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

MEDICATION GUIDE

Effient™ (Ef′-fee-ent)

(prasugrel)

Tablets

Read this Medication Guide before you start taking Effient 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 Effient?

  • Effient is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, Effient can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take Effient 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 Effient and then have heart bypass surgery.
  • Do not take Effient if you:
    • currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head
    • have a history of stroke, or “mini-stroke” (transient ischemic attack or TIA)
    • are allergic to prasugrel or any of the ingredients in Effient. See the end of this Medication Guide for a list of ingredients in Effient.
  • You should stop taking Effient if you have a stroke.
  • Whenever possible, you should stop taking Effient at least 7 days before any surgery, as instructed by the doctor who prescribed Effient for you.

You may also have a higher risk of bleeding if you take Effient and:

  • 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
  • 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
    • non-steroidal anti-inflammatory drugs (NSAIDs) for a long time

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.

  • Effient increases your risk of bleeding because it lessens the ability of your blood to clot. While you take Effient:
    • 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 can not control
    • pink or brown urine
    • red or black stools (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 Effient without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking Effient too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop Effient because of bleeding, your risk of a heart attack may be higher. See “What are the possible side effects of Effient?” for more information about side effects.

What is Effient?

Effient 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).

Effient 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. Effient helps prevent platelets from sticking together and forming a clot that can block an artery or a stent.

It is not known if Effient is safe and works in children.

What should I tell my doctor before taking Effient?

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

  • have any bleeding problems
  • have a history of stomach ulcers, colon polyps, diverticulosis
  • have liver 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 Effient?”
  • pregnant, or are planning to get pregnant. It is not known if Effient will harm your baby.
  • if you are breast-feeding. It is not known if Effient passes into your breast-milk. You and your doctor should decide if you will take Effient or breast-feed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking Effient. They should talk to the doctor who prescribed Effient 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 Effient?”

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 Effient?

  • Take Effient exactly as prescribed by your doctor.
  • Take Effient one time each day.
  • You can take Effient with or without food.
  • Take Effient with aspirin as instructed by your doctor.
  • Your doctor will decide how long you should take Effient. Do not stop taking Effient without first talking to the doctor who prescribed it for you. See “What is the most important information I should know about Effient?”
  • If you miss a dose, take Effient 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 Effient, call your local emergency room or poison control center right away.

What are the possible side effects of Effient?

Effient can cause serious side effects, including:

  • See “What is the most important information I should know about Effient?”
  • A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with Effient, 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 can not 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

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 Effient. 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 Effient?

  • Keep Effient at room temperature between 59°F to 86°F (15°C to 30°C).
  • Keep Effient in the container it comes in.
  • Keep the container closed tightly with the gray cylinder inside.
  • Protect Effient from moisture.

Keep Effient and all medicines out of the reach of children.

General Information about Effient

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Effient for a condition for which it was not prescribed. Do not give your Effient to other people, even if they have similar symptoms. It may harm them.

This Medication Guide summarizes the most important information about Effient. If you would like more information about Effient, talk with your doctor or pharmacist. For more information, call 1-800-545-5979 or go to the following website: www.Effient.com

What are the ingredients in Effient?

Active Ingredient: prasugrel

Inactive Ingredients: mannitol, hypromellose, croscarmellose sodium, microcrystalline cellulose, and vegetable magnesium stearate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10 mg tablet).

*The brands listed are trademarks of their respective owners and are not trademarks of Daiichi Sankyo, Inc. or Eli Lilly and Company.

Revised: December 6, 2010

Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285

Marketed by Daiichi Sankyo, Inc. and Eli Lilly and Company

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Copyright © 2009, 2010, Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

PV 6181 AMP

PACKAGE LABEL – Effient 10 mg 30 Tablets

Effient TM

(prasugrel) tablets

10 mg

Rx only

Each tablet contains prasugrel hydrochloride* equivalent to 10 mg prasugrel

*see package insert section 11

Dispense accompanying Medication Guide to each patient.

image of 10 mg package label
(click image for full-size original)
EFFIENT prasugrel hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6238(NDC:0002-4759)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRASUGREL HYDROCHLORIDE (PRASUGREL) PRASUGREL 10 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
HYPROMELLOSES
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
LACTOSE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color brown (beige) Score no score
Shape HEXAGON (6 sided) (double-arrow) Size 11mm
Flavor Imprint Code 10;mg;4759
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6238-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022307 03/15/2011
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2011 Physicians Total Care, Inc.

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