Generic Name: mifepristone (MIF-e-PRIS-tone)
Brand Name: Mifeprex
Serious and sometimes fatal infections or bleeding may rarely occur following any abortion, including those caused by mifepristone. Read the Medication Guide and Patient Agreement that come with mifepristone. Ask your doctor any questions that you may have. Make sure you are given clear instructions. Be sure you understand whom to call and what to do in case of an emergency. This includes going to the nearest emergency room if your doctor is not available. Contact your doctor if you experience persistent fever, severe stomach pain, fast heartbeat, prolonged heavy vaginal bleeding, or fainting.
If mifepristone does not work within 2 days, your doctor may give you another medicine called misoprostol. If you experience stomach pain or discomfort, weakness, nausea, vomiting, or diarrhea for more for than 24 hours after taking misoprostol, contact your doctor immediately or seek emergency medical care.
If you go to an emergency room or another health care provider, take the Medication Guide with you so they will know that you are taking mifepristone. If mifepristone does not cause a complete abortion, you may need surgery. Talk with your doctor for more information.
Mifepristone is used for:
Ending pregnancy in women who have been pregnant for 49 days (7 weeks) or less. It may be used with other medicines. If mifepristone does not work, surgery to end the pregnancy may be necessary.
Mifepristone is a synthetic steroid. It works by blocking a hormone (progesterone) necessary for pregnancy to continue.
Do NOT use mifepristone if:
- you are allergic to any ingredient in mifepristone, misoprostol, or similar medicines
- you are taking anticoagulants (eg, warfarin, heparin) or corticosteroids (eg, prednisone, dexamethasone)
- you have an intrauterine device (IUD) in place
- you have a pregnancy outside the uterus (ectopic pregnancy)
- you have adrenal gland problems (chronic adrenal failure) or Addison disease
- you have bleeding problems or certain blood problems (eg, porphyria)
- you have an undiagnosed growth in the abdomen
- you are unable to follow-up with your heath care provider or you are unable to get emergency medical care for any serious problems that might occur within several weeks after taking mifepristone
- you do not understand the effects of mifepristone or the follow-up treatment procedures or you are unable to comply with the instructions given by your health care provider
Contact your doctor or health care provider right away if any of these apply to you.
Before using mifepristone:
Some medical conditions may interact with mifepristone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have breathing, heart, liver, lung, or kidney problems; diabetes; anemia; or high blood pressure
- if you will be undergoing general anesthesia
- if you are older than 35 years old and you also smoke 10 or more cigarettes per day
Some MEDICINES MAY INTERACT with mifepristone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) or corticosteroids (eg, hydrocortisone) because the risk of side effects, including excessive bleeding, may be increased
- Azole antifungals (eg, itraconazole, ketoconazole) or erythromycin because they may increase the risk of mifepristone's side effects
- Certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), dexamethasone, rifampin, or St. John's wort because they may decrease mifepristone's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if mifepristone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use mifepristone:
Use mifepristone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Mifepristone comes with an extra patient information sheet called a Medication Guide and a Patient Agreement. Read them carefully. Read them again each time you get mifepristone refilled.
- Mifepristone is supplied by your health care provider and is not available at a pharmacy.
- Mifepristone requires 3 visits to your health care provider.
- On day 1 at your health care provider's office, you will read the Medication Guide and discuss the benefits and risks of using mifepristone to end your pregnancy. If you decide mifepristone is right for you, sign the Patient Agreement. After your physical exam, you will take 3 tablets of mifepristone.
- On day 3 at your health care provider's office, if you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your health care provider may give you other medicines for these symptoms.
- Around day 14 at your health care provider's office, you will return for an important follow-up visit. You must return about 14 days after you have taken mifepristone to be sure the pregnancy has ended. If the pregnancy has not ended, there is a chance of birth defects. Your health care provider will discuss with you your choices, including surgical abortion.
- Grapefruit and grapefruit juice may increase the risk of side effects from mifepristone. Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking mifepristone.
- You must follow the dosing schedule as directed by your doctor. If you miss an appointment, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use mifepristone.
Important safety information:
- Mifepristone may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use mifepristone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Make sure that your health care provider gives you clear instructions and a telephone number that you can call in case of an emergency or if you have any problems or concerns.
- If you are using an IUD, it should be removed before treatment with mifepristone begins.
- Mifepristone should not be used if your pregnancy is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. In fact, it may cause very serious internal or external bleeding.
- You can become pregnant again immediately after using mifepristone. To avoid pregnancy, start using birth control as soon as your pregnancy ends and before you start having sexual intercourse again.
- Tell your doctor or dentist that you take mifepristone before you receive any medical or dental care, emergency care, or surgery. Take the Medication Guide with you if you go to an emergency room or another health care provider so they will know that you are taking mifepristone.
- Lab tests, including human chorionic gonadotropin (hCG) levels and ultrasonographic scan, may be performed while you use mifepristone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Mifepristone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result. It is not known if this medicine is found in breast milk. Because the effects of mifepristone on infants are not known, contact your doctor if you are breast-feeding to determine if you should discard your breast milk for a few days following treatment.
Possible side effects of mifepristone:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; chills/shaking; diarrhea; dizziness; headache; nausea; stomach (menstrual-like) pain and/or cramping; tiredness; vaginal bleeding or discharge; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast heartbeat; fever (100.4 degrees F [38 degrees C] or higher); heavy vaginal bleeding (enough to soak through 2 thick full-size sanitary pads per hour for 2 straight hours, or if you are concerned about heavy bleeding); pelvic pain or tenderness; severe dizziness, light-headedness, or headache; severe or persistent nausea, vomiting, or diarrhea; severe stomach pain; shortness of breath; unusual weakness; vaginal discomfort, itching, or unusual discharge.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of mifepristone:
Mifepristone is usually handled and stored by a health care provider. Keep mifepristone out of the reach of children and away from pets.
- If you have any questions about mifepristone, please talk with your doctor, pharmacist, or other health care provider.
- Mifepristone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take mifepristone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mifepristone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mifepristone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using mifepristone.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.