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Mifepristone

Termination of Pregnancy

  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical and medical abortions, including following the use of mifepristone. No causal relationship between the use of mifepristone and misprostol and these events has been established. Before prescribing mifepristone, inform the patient about the risks of these serious events and discuss the MEDICATION GUIDE and the PATIENT AGREEMENT. Ensure the patient knows whom to call and what to do, including going to the Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol.
  • Patients should be advised to take their MEDICATION GUIDE with them if they visit an emergency room or another health care provider who did not prescribe mifepristone, so that the provider will be aware that the patient is undergoing a medical abortion

Atypical Presentation of INFECTION

  • Patients with serious bacterial infections (e.g. Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis (See Product Labeling Warnings)

BLEEDING

  • Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience heavy vaginal bleeding. (See Product Labeling Warnings)

FDA and Industry Communications

Approved Risk Evaluation and Mitigation Strategies (REMS)

MIFEPREX (mifepristone) Tablets

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Mifepristone

Updated January 2018