Mifeprex

DRUG DESCRIPTION

Mifeprex tablets each contain 200 mg of mifepristone, a synthetic steroid with antiprogestational effects. The tablets are light yellow in color, cylindrical and biconvex, 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 11?-[p-(Dimethylamino)phenyl]-17?-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one. Its empirical formula is C29H35NO2. Its structural formula is:

MIFEPREX® (mifepristone)  Structural Formula Illustration

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 mifepristone (Mifeprex)?

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...

Read All Potential Side Effects and See Pictures of Mifeprex »

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...

Read All Potential Precautions of Mifeprex »


Mifeprex Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, weakness, or dizziness may occur. If these effects persist longer than the first 24 hours after taking the second drug (misoprostol), seek immediate medical attention because they can be signs of a serious medical problem.

Bleeding and cramping are expected during this treatment. Usually, the symptoms mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. Therefore, you must return for all 3 of your doctor visits. Nausea and cramping may worsen in the 24 hours after you take the second drug (misoprostol). Your doctor may direct you to take other medication to help with these symptoms. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Bleeding and spotting may last up to 30 days and may be much heavier than a normal period. In very few cases, this bleeding will need to be stopped by surgery. Seek immediate medical attention if you bleed enough to soak through 2 thick, full-size sanitary pads each hour for 2 hours in a row, or if you are concerned about heavy bleeding.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if you have any of these unlikely but very serious side effects: fever of 100.4 degrees F (38 degrees C) or higher, fainting, fast heartbeat, stomach/abdominal pain or tenderness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 pregnancy outside the womb (ectopic pregnancy), unable to return for a doctor's visit in 48 hours and again in 14 days, unable to easily get emergency help in the 2 weeks after taking mifepristone.

If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood count (anemia), smoking more than 10 cigarettes a day.

This drug must be used only if you can easily reach adequate emergency medical services in case you have a serious medical problem.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result.

Another pregnancy can occur after this abortion treatment and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Consult your doctor for more information.

It is not known whether this drug passes into breast milk. Since the effects of mifepristone on infants are unknown, breast-feeding women should consult their doctors on whether they should discard their breast milk for a few days following this treatment.


Mifeprex Patient Information Including Side Effects

Brand Names: Mifeprex

Generic Name: mifepristone (Pronunciation: mih feh PRIH stone)

  • What is mifepristone (Mifeprex)?
  • What are the possible side effects of mifepristone (Mifeprex)?
  • What is the most important information I should know about mifepristone (Mifeprex)?
  • What should I discuss with my healthcare provider before taking mifepristone (Mifeprex)?
  • How should I take mifepristone (Mifeprex)?
  • What happens if I miss a dose (Mifeprex)?
  • What happens if I overdose (Mifeprex)?
  • What should I avoid while taking mifepristone (Mifeprex)?
  • What other drugs will affect mifepristone (Mifeprex)?
  • Where can I get more information?

What is mifepristone (Mifeprex)?

Mifepristone 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.

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

What are the possible side effects of mifepristone (Mifeprex)?

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. You may report side effects to FDA at 1-800-FDA-1088.

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

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone 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.

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