Warnings:

Rarely, serious medical problems can occur when a pregnancy ends (for example, due to medical abortion with medications including mifepristone, surgical abortion, miscarriage), including sometimes fatal infections and bleeding. Read the Medication Guide, read and sign the Patient Agreement, and consult your doctor if you have any questions. This medication is available only through a restricted program called the Mifepristone Shared REMS Program. Only doctors enrolled in the program may prescribe and give this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Your doctor must give you clear instructions regarding whom to call and what to do in case of an emergency (e.g., severe bleeding, infection). If you go to the emergency room or visit another health care professional, show them the Medication Guide so they know you are having a medical abortion.

Seek immediate medical attention if you experience symptoms such as severe abdominal pain, fainting, fast heartbeat, fever lasting more than 4 hours. You may have a very serious infection even if you do not have a fever. Therefore, seek immediate medical attention if you have abdominal pain or feel sick (for example, if you have nausea, vomiting, diarrhea, weakness) more than 24 hours after taking the second drug (misoprostol), even if you do not have a fever. Also seek immediate medical attention if you have continued heavy bleeding, which may be a sign of an incomplete abortion or other serious medical problem. You may need surgery or other medical care. See also Side Effects section.

Uses

Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 10 of pregnancy (up to 70 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol.Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

How to use Mifeprex

Read the Medication Guide provided by your doctor before you start using mifepristone. Keep the guide to reread if needed. If you have any questions, consult your doctor or pharmacist. Read and sign the Patient Agreement form provided by your doctor. Tell your doctor if you do not understand how to use this medication or cannot follow the instructions. Mifepristone is available only from your doctor. It is not available from store pharmacies.

You must visit the doctor's office at least 2 times to complete your treatment and important examinations. This treatment is only given under direct medical supervision in a doctor's office, clinic, or hospital. Be sure to have clear instructions from your doctor regarding whom to call and what to do in case of an emergency.

Your doctor may want to do an ultrasound to make sure your pregnancy is less than 10 weeks and is not outside the womb (ectopic).

Take mifepristone by mouth as directed by your doctor, usually as a single dose. After taking mifepristone, your doctor should direct you to wait 24 to 48 hours before taking another medication (misoprostol) by mouth as a single dose. The medications may not work as well if you take misoprostol sooner than 24 hours after taking mifepristone or later than 48 hours after taking mifepristone. Follow your doctor's instructions carefully. Heavy vaginal bleeding does not mean that an abortion is complete.

Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise.

It is important that you return for a follow-up visit within 7 to 14 days after taking mifepristone, even if you are not having any problems.

If abortion does not occur or is not complete, or there are serious medical problems, surgery may be needed. If the treatment fails and the pregnancy continues until birth, there is a risk of birth defects.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.