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Mifepristone

This form:

Warning

Rarely, serious medical problems can occur when a pregnancy ends, 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. To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Mifepristone REMS Program. 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 about who to call and what to do in case of an emergency (such as 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 trying to end your pregnancy.

Get medical help right away 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. Get medical help right away 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 get medical help right away if you have continued heavy bleeding, which may be a sign the pregnancy has not ended or other serious medical problem. You may need surgery or other medical care. See also Side Effects section.

Precautions

Before taking mifepristone, tell your doctor if you are allergic to it; or to misoprostol; or to other progestins (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: undiagnosed abdominal growth (adnexal mass), adrenal gland problem, certain blood disorder (inherited porphyrias), bleeding problems, low blood count (anemia).

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

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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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 treatment with this medication 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.

This medication passes into breast milk. Since the effects of mifepristone on infants are unknown, breastfeeding women should consult their doctors on whether they should discard their breast milk for a few days following this treatment.

Side Effects

See also Warning section.

Nausea, vomiting, diarrhea, weakness, or dizziness may occur. If these effects last longer than the first 24 hours after taking the second drug (misoprostol), get medical help right away 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. You must return for all of your follow-up visits with your doctor. Nausea and cramping may get worse 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 last or get worse, 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. Get medical help right away 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 this medication has been prescribed because your doctor 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.

Get medical help right away if you have any very serious side effects, including: 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, get medical help right away 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 or at www.fda.gov/medwatch.

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

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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