What is Mifeprex (Mifepristone)?

Mifeprex blocks the actions of the naturally occurring hormone progesterone, which is necessary for pregnancy to continue.

When used together with another medicine called misoprostol, mifepristone is used to end an early pregnancy.

Mifeprex may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mifeprex (mifepristone)?

Mifeprex is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifeprex must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

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 need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What should I discuss with my healthcare provider before taking Mifeprex (mifepristone)?

Do not take mifepristone if

• it has been more than 49 days (7 weeks) since your last menstrual period began;
• you have an IUD;
• your healthcare provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy);
• you have problems with your adrenal glands (chronic adrenal failure);
• you take a medicine such as warfarin (Coumadin) to thin your blood;
• you have a bleeding problem;
• you take certain steroid medicines;
• you cannot return for the next 2 visits;
• you cannot easily get emergency medical help in the 2 weeks after you take mifepristone; or
• you are allergic to medicines that contain misoprostol, such as Cytotec or Arthrotec.

Before taking mifepristone, tell your healthcare provider about any other medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to take mifepristone, or you may require special monitoring during treatment.

Mifeprex is in the FDA pregnancy category X. This means that mifepristone is known to cause birth defects in an unborn baby. Mifeprex treatment that does not end in termination of pregnancy may cause birth defects in the unborn baby. It is not known whether mifepristone passes into breast milk. Do not take mifepristone without first talking to your doctor if you are breast-feeding a baby.

How should I take Mifeprex (mifepristone)?

Take mifepristone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Mifeprex is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifeprex must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

On Day 1 at your healthcare provider's office, you will read the Medication Guide for mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets of mifepristone.

When you return to your healthcare provider's office on Day 3, your healthcare provider will check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms.

About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare provider's office to be sure you are well and that you are not pregnant. Your healthcare provider will check to see whether the pregnancy has completely ended. If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

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 need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What happens if I miss a dose?

Your doctor will administer mifepristone, so you will not miss a dose.

What happens if I overdose?

An overdose of mifepristone is unlikely to threaten life and is unlikely to occur since the tablets are administered at your doctor's office.

Symptoms of a mifepristone overdose are not known.

What should I avoid while taking Mifeprex (mifepristone)?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

Mifeprex (mifepristone) side effects

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 need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

Other less serious side effects may include:

• diarrhea, nausea, vomiting;
• headache or dizziness;
• back pain; or
• tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Mifeprex (mifepristone)?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.