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Mifepristone: This medication is taken first and works by blocking the hormone progesterone, which is necessary for the pregnancy to continue. Without this hormone, the lining of the uterus breaks down, and the pregnancy cannot continue.





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Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period). The approved mifepristone dosing regimen is:



On day one: 200 mg of mifepristone taken by mouth



24 to 48 hours after taking mifepristone: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient



About seven to fourteen days after taking mifepristone: follow-up with the health care provider



When did the FDA approve mifepristone for medical termination of pregnancy?



The FDA first approved Mifeprex (mifepristone) in September 2000 for medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019. The agency’s approval of this generic reflects the FDA’s determination that Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation. The labeling for the approved generic version of Mifeprex is consistent with the labeling for Mifeprex.



Who should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy?



An individual should not take mifepristone, in a regimen with misoprostol, for medical termination of pregnancy if it has been more than 70 days since the first day of their last menstrual period, or if they:



have an ectopic pregnancy (a pregnancy outside of the uterus)



have problems with the adrenal glands (the glands near the kidneys)



are currently being treated with long-term corticosteroid therapy (medications)



have had an allergic reaction to mifepristone, misoprostol or similar drugs



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have inherited porphyria (a rare disorder that can affect the liver and other organs)



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The US first approved mifepristone for the medical termination of pregnancy through seven weeks gestation in September 2000. In 2016, its approved use was extended to 10 weeks of pregnancy.







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