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|Mifepristone

Mifepristone

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 blood thinners (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 , 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 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 of age 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:

• St. John"s wort because the effectiveness of Mifepristone may be decreased
• Anticoagulants (eg, warfarin) or corticosteroids (eg, hydrocortisone) because the risk of side effects, including excessive bleeding, may be increased

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 additional patient information sheet called a Medication Guide. Read it carefully and reread it 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.
• Avoid drinking grapefruit juice 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mifepristone . Using Mifepristone alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• 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.
• Before you have any medical or dental treatments, emergency care, laboratory tests, or surgery, tell the doctor or dentist that you are using Mifepristone .
• LAB TESTS, including human chorionic gonadotropin (hCG) levels and ultrasonographic scan, and health care provider"s appointments will be required to monitor your progress. Be sure to keep all doctor and lab appointments.
• Mifepristone is not recommended for use in CHILDREN. Safety and effectiveness 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 unknown if Mifepristone is excreted in breast milk. Because the effects of Mifepristone on infants are unknown, 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:

Abdominal (menstrual-like) pain and/or cramping; anxiety; back pain; chills/shaking; diarrhea; dizziness; headache; indigestion; nausea; tiredness; vaginal bleeding or discharge; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast heartbeat; fever (100.4 degrees F 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); infection; pelvic pain; severe abdominal pain; vaginal discomfort, itching, or unusual discharge.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Mifepristone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mifepristone out of the reach of children and away from pets.

General information:

• 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.

This information is a summary only. It does not contain all information about Mifepristone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.