Drugs & Vitamins

Mifepristone Active Ingredients: Mifepristone Representative Names: Mifeprex, RU-486 What are mifepristone tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with mifepristone? What side effects may I notice from taking mifepristone? What should I watch for while taking mifepristone? Where can I keep my medicine? What are mifepristone tablets? (Back to top) MIFEPRISTONE (Mifeprex® or RU-486) is a hormone-like drug. Mifepristone is used in combination with other medications, called prostaglandins, to end an early pregnancy (usually during the first 7 weeks). Mifepristone has been used for emergency birth control after unprotected sexual intercourse. Because mifepristone has hormone-like actions, it is also being studied for the treatment of certain reproductive diseases or cancers. Generic mifepristone is not available. Mifepristone is not available in pharmacies in the US; mifepristone is only available in a prescriber's office, health clinic, or hospital. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •it has been more than 49 days since your last menstrual period began •have an intrauterine device in your uterus (an 'IUD') •live in an area where it would not be easy to get emergency medical help in the 2 weeks after you take this medicine •tubal or ectopic pregnancy You should also not take this medicine if: •adrenal gland problems •hemophilia or any other bleeding or bleeding problems •kidney disease •liver disease •porphyria •smoke 10 or more cigarettes per day •take certain steroid medications like prednisone •take a medication used to thin the blood like warfarin (Coumadin®) or an injectable 'blood thinner' •an unusual or allergic reaction to mifepristone, misoprostol, prostaglandins, or other medicines, foods, dyes, or preservatives •breast-feeding •If you are taking this medication for a purpose other than to end an early pregnancy, tell your prescriber if you think you may be pregnant. How should I take this medicine? (Back to top) Take exactly as directed. Prior to taking this medication, read the provided Medication Guide from your prescriber. Make sure you understand the information. Discuss the use of this medication and how you will need to be monitored with your prescriber. For pregnancy termination: You will need to visit your prescriber 3 times. On the first visit, mifepristone is taken by mouth as a single dose in the prescriber's office. Two days later (48 hours after mifepristone) you will need to see your prescriber again for an exam. If your pregnancy has not ended at that time, your prescriber will give you a second medication, called misoprostol, and more instructions. You will experience cramping and bleeding; your prescriber will give you instructions to follow for these effects, including what to do if an emergency occurs. You MUST follow-up with a visit to the prescriber 2 weeks after mifepristone to make sure the pregnancy has ended and to get a complete exam to make sure you are well. Do not miss this appointment. For other uses: Mifepristone is taken by mouth at roughly the same time daily for other uses with a sip of water. Follow the directions of your prescriber. This medicine is not for use in children. What if I miss a dose? (Back to top) For pregnancy termination: This does not apply, mifepristone is given in your prescriber's office only. Keep all scheduled doctor's visits during your treatment. For other uses: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with mifepristone? (Back to top) Ask our prescriber about medications that you may take for pain or cramps. Do not take any other medications, non-prescription drugs, or herbal or dietary supplements during your treatment without the approval of your prescriber. Medications that can interfere with mifepristone or that mifepristone may interact with may include: •anticoagulants ('blood thinners', like warfarin, heparin or enoxaparin) •astemizole •cilostazol •cisapride •corticosteroids like dexamethasone or prednisone •cyclosporine •dofetilide •doxercalciferol •erythromycin •grapefruit juice •medicines for anxiety or sleeping problems, such as alprazolam or triazolam •medicines for fungal infections (ketoconazole, itraconazole, voriconazole) •medications for high blood pressure or to regulate heartbeat •medications for high cholesterol or blood fats •medicines for seizures (carbamazepine, phenytoin, phenobarbital) •medications for treating HIV infection or AIDS •medications used in surgery for anesthesia •paricalcitol •pimozide •rifampin •sildenafil •sirolimus •St. John's wort or other herbal products •tacrolimus •terfenadine Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking mifepristone? (Back to top) The following side-effects listed relate to the use of mifepristone to end an early pregnancy. Side effects that you should report to your prescriber or health care professional as soon as possible: •any unusual side effects that concern you •bad-smelling vaginal discharge •fainting •fast, slow, or irregular heartbeat, palpitations, chest pain •fever •redness, blistering, peeling or loosening of the skin, including inside the mouth •severe abdominal pain or cramps •skin rash •very heavy vaginal bleeding (bleeding enough to soak 2 full-size sanitary pads per hour for 2 consecutive hours; or if you are concerned about the amount of blood being passed) •continued vomiting •weakness Side effects that usually do not require medical attention. These side effects are common and will usually decrease after day 3 and are usually gone after 2 weeks (report to your prescriber or health care professional if they continue or are bothersome): •back pain •diarrhea •dizziness •feeling tired •headache •hot flashes •mild abdominal cramps •mild nausea or vomiting •temporary reduction in appetite •vaginal bleeding (spotting for roughly 9—16 days, may be similar in amount to a menstrual period) What should I watch for while taking mifepristone? (Back to top) Visit your prescriber as instructed to make sure you have responded to the treatment. Report any unusual effects to your prescriber. If you are taking this medication to end a pregnancy, tell your prescriber if you do not have any vaginal bleeding after 5 days. Note that prolonged or heavy vaginal bleeding is not proof of a complete termination of the pregnancy, so you must visit your prescriber as directed to check that the treatment worked and that you are well. If the medication does not work, you may need surgery to end the pregnancy, and there is a risk of birth defects. In about 1 of every 100 women, bleeding can be so heavy it requires a surgical procedure to stop it. This is why you must be able to get emergency care if needed. Your provider will tell you how you must handle emergencies. If you have abdominal pain or discomfort, or you are 'feeling sick', with symptoms of weakness, nausea, vomiting or diarrhea, more than 24 hours after your treatment, you should contact your provider without delay. These symptoms may be a sign of a serious infection or an ectopic pregnancy (a pregnancy outside the womb). Also, if you have a fever of 100.4 degrees F or higher that lasts for more than 4 hours, you should contact your provider right away. Fever may be a symptom of a serious infection or another serious problem. Where can I keep my medicine? (Back to top) This does not apply. This medicine is kept at the prescriber's office. You will not take this medicine home with you. Last Updated:08/30/2005 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.