"Risk factors for repeat pregnancy terminations include teenage pregnancy, social deprivation, two or more previous live births or miscarriages at the time of the initial termination, and the use of posttermination contraception with implants and "...
SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
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.
- 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 AND PRECAUTIONS].
- Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or othercomplications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavyvaginal bleeding [see WARNINGS AND PRECAUTIONS].
Because of the risks of serious complications described above, MIFEPREX is available only through a restricted program under a Risk Evaluation and Mitigation Strategy(REMS) called the MIFEPREX REMS Program [see WARNINGS AND PRECAUTIONS].
Before prescribing MIFEPREX, inform the patient about the risk of these seriousevents. 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 ifshe experiences abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
Advise the patient to take the Medication Guide with her if she visits an emergencyroom or a healthcare provider who did not prescribe MIFEPREX, so that the provider knows that she 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 bi-convex, 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 Mifeprex (Mifeprex)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Bleeding and spotting are normal side effects of Mifeprex. Bleeding may be slightly heavier than a normal period. Call your doctor right away if you bleed enough to soak through 2 full-size sanitary pads per hour for 2 hours in a row.
Call your doctor at once if you have any other serious side effect, such as:
- general ill feeling and fast heart rate;
- a fever higher than 100.4 degrees F (38...
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: 4/12/2016
This monograph has been modified to include the generic and brand name in many instances.
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