Oral anticoagulants, NSAIDs, Clopidogrel, fibrinoltics, heparin, Cyclophophamide, Efavirenz

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

Effient safely and effectively. See full prescribing information for Effient. EFFIENT (prasugrel) tablets

Initial U.S. Approval: 2009

Prevention of atherothrombtic events in patients undergoing coronary intervention

Proprietary  Name- Effient

GI and other haemorrhage, anemia, hematoma, epitasxis, eye bleed, stroke, rash, newly diagonosed neoplasm, confusion

Severe hepatic impairment Active pathological bleeding History of stroke or TIA, Lactation

Special precautions-

Renal impairment, mild to moderate hepatic impairment Increased risk of bleeding (trauma, syrgery, recent ur recurrent GI bleed, active peptic ulcer) Anaemia, thrombocytopaenia, intracranial pathology history. Premature discontinuation.

Elderly over 75 years- treat only f benfit exceed risk. Discontinue at least 7 days prior to elective surgery if platelet effect not desired.

CABG surgery surgery within 7 days of discontinuation of therapy Advice patients to report any unusual bleeding. Galactose intolerance. laap

Lactase deficiency. Glucose or galactose malabsorption Pregnancy

Dosage-

Intially 60mg as a single dose Maintenance- under 60kg - 5mg daily 60kg or over- 10mg daily Continue treatment for up to 12 months unless discontinuation clinically indicated

Elderly- over 75 years- Initially 60mg as a single dose then 5mg daily

Patients below 18 years- not recommended

 PATIENT COUNSELING INFORMATION

See Medication Guide

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.

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.

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.

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.

.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).

Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285 Marketed by Daiichi Sankyo, Inc. and Eli Lilly and Company Copyright ©2009, yyyy, Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved. 3.0 NL 7310 AMP PRINTED IN USA

Pregnancy- excercise caution.

Lactation-- contraindicated