(mifepristone) Tablets, 200 mg
For Oral Administration Only
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex* use. No causal relationship between the use of Mifeprex and misoprostol and these events has been established. Before prescribing Mifeprex, inform the patient about the risk of these serious events and discuss the MEDICATION GUIDE and the PATIENT AGREEMENT. Ensure that the patient knows whom to call and what to do, including going to an 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.
- 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 who presented 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 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 prolonged heavy vaginal bleeding (see WARNINGS).
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 Mifeprex, so that provider will be aware that the patient is undergoing a medical abortion.
Mifeprex tablets each contain 200 mg of mifepristone, a synthetic steroid with antiprogestational effects. The tablets are light yellow in color, cylindrical and biconvex, and are intended for oral administration only. The tablets include the inactive ingredients colloidal silica anhydrous, corn starch, povidone, microcrystalline cellulose, and magnesium stearate.
Mifepristone is a substituted 19-nor steroid compound chemically designated as 11β-[p-(Dimethylamino)phenyl]-17β-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one. Its empirical formula is C29H35NO2. Its structural formula is:
The compound is a yellow powder with a molecular weight of 429.6 and a melting point of 192-196°C. It is very soluble in methanol, chloroform and acetone and poorly soluble in water, hexane and isopropyl ether.
What are the possible side effects of mifepristone (Mifeprex)?
Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you...
What are the precautions when taking mifepristone (ru486) (Mifeprex)?
Before taking mifepristone, tell your doctor if you are allergic to it; or to misoprostol; or to other progestins (e.g., norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions or other problems. Before using this medicine, consult your doctor if you have any of the following: undiagnosed abdominal growth (adnexal mass), certain adrenal gland problem (chronic adrenal failure), bleeding problem (e.g., coagulopathy), certain blood disorder (inherited porphyrias), IUD (intrauterine birth control device) in place, pregnancy longer than 7 weeks, proven or possible abnormal...
Last reviewed on RxList: 6/27/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mifeprex Information
Mifeprex - User Reviews
Mifeprex User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.