Prasugrel patient counseling information

Prasugrel
EFFIENT® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Prasugrel
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Patient Counseling Information

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.

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 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.

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 Effient.

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.

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 November 14, 2013

Effient® is a registered trademark of Eli Lilly and Company.

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

Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLC

Copyright ©2009, 2013 Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

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