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Author ------ Message
 Author: crow
PostPosted: Wed Mar 30, 2016 4:16 pm 
Mifeprex (mifepristone) Information

Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application for Mifeprex based on data and information submitted by the drug manufacturer. After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling.

FDA-Approved Regimen (2016):

Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period).

The approved Mifeprex dosing regimen is:
• On Day One: 200 mg of Mifeprex taken by mouth
• 24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
• About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider

Risk Evaluation and Mitigation Strategy (REMS)

The FDA previously approved a REMS for Mifeprex. After reviewing the supplemental application, the agency determined that a REMS continues to be necessary to ensure the safe use of Mifeprex. Under the REMS:
Mifeprex must be ordered, prescribed and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications;
Healthcare providers who wish to prescribe Mifeprex must complete a Prescriber Agreement Form prior to ordering and dispensing Mifeprex;
Mifeprex may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider;
The healthcare provider must obtain a signed Patient Agreement Form before dispensing Mifeprex.

Healthcare providers who prescribe Mifeprex are required under FDA regulations to provide the patient with a copy of the Mifeprex Medication Guide (FDA-approved information for patients).

To learn more, please see Mifeprex (mifepristone) Questions and Answers.

# # #
http://www.fda.gov/Drugs/DrugSafety/Pos ... 111323.htm


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