mifepristone (Mifeprex)

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

This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.

What is mifepristone (Mifeprex)?

Mifeprex blocks the actions of a hormone needed to maintain a pregnancy.

Mifeprex is used to end an early pregnancy that is not further along than 70 days (10 weeks) after the first day of your last menstrual period. Mifeprex is used together with another medicine called misoprostol (Cytotec).

Mifeprex is available from a certified healthcare provider and from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medicine.

This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.

Mifeprex may also be used for purposes not listed in this medication guide.

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

Treatment with Mifeprex and misoprostol requires at least 2 visits to your doctor. Do not use this medicine if you cannot attend all required follow-up visits.

• it has been more than 70 days (10 weeks) since your last menstrual period began;
• you cannot easily get emergency medical help if needed in the 2 weeks after you take these medicines;
• you have an intrauterine device, or IUD (it must be removed before you take Mifeprex);
• you have a pregnancy outside the uterus (ectopic pregnancy);
• you have problems with your adrenal glands (chronic adrenal failure);
• you have a bleeding or blood-clotting disorder, such as hemophilia;
• you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• you have a condition for which you use a blood thinner such as warfarin (Coumadin, Jantoven);
• you have a condition for which you have been taking steroid medicine for a long period of time; or
• you are allergic to prostaglandins.

To make sure Mifeprex is safe for you, tell your doctor if you have:

• a history of uterine rupture or uterine scar.

How is Mifeprex given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before receiving this medicine, you must read a Mifeprex Medication Guide. Then, you must sign a Patient Agreement form stating that you understand the risks and benefits of using this medicine.

Complete treatment to end the pregnancy will require at least 2 visits to your doctor.

• At the first visit (Day 1) you will be given a Mifeprex tablet. You will also be given or prescribed 4 misoprostol tablets. If you receive only a prescription for misoprostol, be sure to get the prescription filled right away so you will be ready to take the medicine on schedule.
• In 24 to 48 hours, you will take 4 misoprostol tablets at one time. For treatment to be effective, you must take misoprostol 24 to 48 hours after you took Mifeprex.
• Misoprostol can cause cramps, nausea, diarrhea, and other side effects. Your doctor may give you medicine to treat or prevent these side effects.
• Your uterus should begin to pass the pregnancy within 2 to 24 hours after taking misoprostol. Be sure you are in a place where you will be ready for this to happen. You will likely have fairly heavy vaginal bleeding while your uterus is passing the pregnancy.
• At the second visit (Day 7 to 14 after you took Mifeprex), your doctor will check your uterus to make sure the pregnancy has completely ended.
• If your body has not completely passed the pregnancy, you may be given another dose of misoprostol. If you take a second dose of misoprostol, you should have a follow-up visit 7 days later.

You may need surgery to end the pregnancy completely. Carrying a pregnancy to term after taking Mifeprex or misoprostol may cause birth defects or death of the baby. Talk with your doctor about your treatment options.

Bleeding and spotting are normal side effects of Mifeprex and misoprostol. It is possible to continue bleeding for up to 30 days. Bleeding may be heavier than a normal heavy period, and you may also pass blood clots and tissue.

It is possible to get pregnant again right after terminating a pregnancy. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.

What happens if I miss a dose?

Mifeprex is used as a single dose and does not have a daily dosing schedule.

What happens if I overdose?

What should I avoid after taking Mifeprex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Grapefruit and grapefruit juice can make it harder for your body to metabolize Mifeprex. Avoid the use of grapefruit products shortly before or after taking Mifeprex.

What are the possible side effects of Mifeprex?

• a fever higher than 100.4 degrees F (38 degrees C) lasting longer than 4 hours;
• confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• a general ill feeling or fast heartbeats;
• severe pelvic pain or tenderness;
• severe or ongoing nausea, vomiting, diarrhea, weakness; or
• no vaginal bleeding at all after taking Mifeprex.

Common side effects may include:

• heavy vaginal bleeding for 2 days;
• light vaginal bleeding or spotting for up to 16 days;
• fever, chills, weakness;
• dizziness; or
• nausea, vomiting, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mifeprex?

Tell your doctor about all your current medicines. Many drugs can affect Mifeprex, especially:

• St. John's wort;
• medication to treat hepatitis or HIV;
• an antibiotic or antifungal medication;
• heart or blood pressure medication;
• seizure medication; or
• tuberculosis medication.

Many drugs can affect Mifeprex, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about Mifeprex.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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