+971566583979 Questions and Answers on Mifepristone' for Medical Termination of Pregnancy Through Ten Weeks Gestation, in Dubai, UAE, Bahrain, Abu Dhabi, Sharjah,Fujairah,Satwa, Al Ain, Al Barsha, Dubai Marina,
+971566583979 General Information
What is mifepristone and how does it work?
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 an intrauterine 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 an 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
have had an allergic reaction to mifepristone, misoprostol or similar drugs
have bleeding problems or are taking anticoagulant (blood thinning) drug products
have inherited porphyria (a rare disorder that can affect the liver and other organs)
have an intrauterine device (IUD) in place (it must be removed before taking mifepristone)
Is it safe to use mifepristone?
Yes. Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it is approved for use for medical termination of pregnancy up to 70 days of gestation. The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.