mifepristone 200 mg tablet

Generic name:
Mifepristone - oral

Pronunciation
(MIF-e-PRIS-tone)

Brand name(s)
Mifeprex

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 mifepristone in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. 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.

Mifepristone (also known as RU 486) is used to end a pregnancy 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 end the pregnancy in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

Read the Medication Guide provided by your doctor before you start using mifepristone. Keep the guide to reread if needed. Read and sign the Patient Agreement form provided by your doctor. If you have any questions, consult your doctor or pharmacist.

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. Learn about who to call and what to do in case of an emergency.

Your doctor may order 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 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 the pregnancy has ended.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

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 the pregnancy has not ended, 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.

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.

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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• long-term corticosteroid therapy (such as prednisone)
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of mifepristone from your body, which may affect how mifepristone works. Examples include azole antifungals (such as itraconazole), dexamethasone, macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Mifepristone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine, some statin drugs (such as fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, warfarin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe vaginal bleeding.

Lab and/or medical tests (such as ultrasound) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

You must follow the dosing and appointment schedule as directed by your doctor. If you miss an appointment, contact your doctor right away.

This drug is available only from your doctor. Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.