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Mifepristone

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IMPORTANT WARNING:

Serious or life threatening vaginal bleeding may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. It is not known if taking mifepristone increases the risk that you will experience very heavy bleeding. Tell your doctor if you have or have ever had bleeding problems, an ectopic pregnancy ('tubal pregnancy' or pregnancy outside the uterus), anemia (less than normal number of red blood cells), or if you are taking anticoagulants ('blood thinners') such as warfarin (Coumadin), heparin, or aspirin. If you experience very heavy vaginal bleeding, such as soaking through two thick full-size sanitary pads every hour for two continuous hours, call your doctor immediately or seek emergency medical care.

Serious or life threatening infections may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. A small number of patients died due to infections that they developed after they used mifepristone and misoprostol to end their pregnancies. Some of these patients had used misoprostol vaginally; vaginal use of oral misoprostol tablets has not been approved by the Food and Drug Administration (FDA). It is not known if mifepristone and/or misoprostol taken vaginally or by mouth caused these infections or deaths.

If you develop a serious infection, you may not have many symptoms and your symptoms may not be very severe. You should call your doctor immediately if you experience any of the following symptoms: fever greater than 100.4 °F that lasts for more than 4 hours, severe pain or tenderness in the area below the waist, chills, fast heartbeat, or fainting .

You should also call your doctor immediately if you have general symptoms of illness such as weakness, upset stomach, vomiting, diarrhea, or feeling sick more than 24 hours after taking mifepristone even if you do not have a fever or pain in the area below your waist.

Your doctor will give you the manufacturer's patient information sheet (Medication Guide) to read before you begin treatment with mifepristone.You will also need to sign a patient agreement before taking mifepristone. Tell your doctor if you have questions about treatment with mifepristone or if you cannot follow the guidelines in the patient agreement.

Talk to your doctor and decide whom to call and what to do in case of an emergency after taking mifepristone. Tell your doctor if you do not think that you will be able to follow this plan or to get medical treatment quickly in an emergency during the first two weeks after you take mifepristone. Take your medication guide with you if you visit an emergency room or seek emergency medical care so that the doctors who treat you will understand that you are undergoing a medical abortion.

Keep all appointments with your doctor.These appointments are necessary to be sure that your pregnancy has ended and that you have not developed serious complications of medical abortion.

Talk to your doctor about the risks of taking mifepristone.

Why is this medication prescribed?

Mifepristone is used alone or in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 49 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy.

How should this medicine be used?

Mifepristone comes as a tablet to take by mouth. It should be taken only in a clinic, medical office, or hospital under the supervision of a qualified doctor. You will take three tablets of mifepristone at one time on the first day. Two days later you must go back to your doctor. If your doctor is not certain that your pregnancy has ended, you will take two tablets of another medication called misoprostol. You may have vaginal bleeding for 9 to 30 days or longer. Fourteen days after taking mifepristone, you must go back to your doctor for an exam or ultrasound to make sure that the pregnancy has ended. Take mifepristone exactly as directed.

Other uses for this medicine

Mifepristone is also sometimes used to end pregnancies when more than 49 days have passed since the woman's last menstrual period; as an emergency contraceptive after unprotected sexual intercourse ('morning-after pill'); to treat tumors of the brain, endometriosis (growth of uterus tissue outside the uterus), or fibroids (noncancerous tumors in the uterus); or to induce labor (to help start the birth process in a pregnant woman). Talk to your doctor about the possible risks of using this drug for your condition.

What storage conditions are needed for this medicine?

Your doctor will store the medication in his or her office.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

dizziness
fainting
blurred vision
upset stomach
tiredness
weakness
shortness of breath
fast heart beat

What other information should I know?

You should get mifepristone only from a doctor and use this medication only while under the care of a doctor. You should not buy mifepristone from other sources, such as the Internet, because you would bypass important safeguards to protect your health.

Do not let anyone else take your medication.

Brand names

Mifeprex®

Other names

RU-486

Notes:

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EditText of this page (last edited November 27, 2009)