Mifepristone (mif-e-PRIS-tone)

Ends a pregnancy that is less than 10 weeks along (70 days or less since the start of your last menstrual period). Also used to control high blood sugar in patients with Cushing syndrome.

Brand Name(s):

Korlym, Mifeprex

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• For patients using mifepristone tablets for termination of pregnancy:
  • Treatment requires 1 tablet of mifepristone and 4 tablets of a medicine called misoprostol.
  • Day One:
    • One 200 mg tablet of mifepristone in a single oral dose.
  • 24 to 48 hours after taking mifepristone tablet:
    • Four 200 microgram (mcg) tablets (total dose 800mcg) of misoprostol. Two 200 mcg tablets are placed in each cheek pouch for 30 minutes. Swallow any remaining pieces with water or other liquid.
    • This medicine must be taken within 24 to 48 hours after mifepristone; no sooner than 24 hours and no later than 48 hours.
  • Most women will expel the pregnancy within 2 to 24 hours of taking misoprostol.
  • You must follow up with your doctor 7 to 14 days after the day one dose of mifepristone. Your doctor will check to make sure you are no longer pregnant. It is very important that you go to your follow-up appointment. Call your doctor if you are not able to make your appointment.
  • This medicine will cause you to bleed and have cramps for about 2 weeks.
• For patients using mifepristone tablets tocontrol high blood sugar:
  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • It is best to take this medicine with food or milk.
  • Swallow the tablet whole. Do not split, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with cyclosporine, dihydroergotamine, ergotamine, fentanyl, lovastatin, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, blood thinner (including warfarin), or steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisone).
• Some foods and medicines can affect how mifepristone works. Tell your doctor knows if you are using any of the following:
  • Bupropion, carbamazepine, clarithromycin, conivaptan, erythromycin, itraconazole, ketoconazole, nefazodone, phenobarbital, phenytoin, posaconazole, repaglinide, rifabutin, rifampin, rifapentine, St John's wort, telithromycin, voriconazole
  • Birth control pills
  • Medicine to treat HIV/AIDS (including amprenavir, atazanavir, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen, celecoxib)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• For patients using mifepristone tablets for termination of pregnancy:
  • Tell your doctor if you are breastfeeding, or if you have adrenal gland problems, blood clotting problems, bleeding disorder, or anemia. Tell your doctor if you have an IUD.
  • After treatment, it is possible for you to get pregnant again, even before you have your next period. You may start using birth control as soon as your pregnancy ends.
  • This medicine may cause the following problems:
    • Serious infection, including sepsis
    • Heavy vaginal bleeding
  • It is sometimes necessary to have a surgical abortion to completely end the pregnancy. You may also need to have surgery if there is any tissue left in your uterus after treatment with mifepristone.
• For patients using mifepristone tablets tocontrol high blood sugar:
  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, you must have a negative pregnancy test before starting and before restarting this medicine if you stop taking it for more than 14 days. Use an effective form of birth control (including condom, diaphragm, or cervical cap) to keep from getting pregnant during treatment with this medicine and for 1 month after the last dose.
  • Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, allergy to aspirin, bleeding disorder, heart failure, high blood pressure, or a history of heart or blood vessel disease or organ transplant.
  • This medicine could cause the following problems:
    • Adrenal gland problems
    • Vaginal bleeding
    • Heart rhythm problems, including QT prolongation
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• For patients using mifepristone tablets for termination of pregnancy:
  • Fever, severe stomach pain, or pelvic tenderness
  • Heavy vaginal bleeding or severe cramping
• For patients using mifepristone tablets tocontrol high blood sugar:
  • Changes in skin color, dark freckles
  • Cold feeling, tiredness, weight loss
  • Dry mouth, increased thirst, muscle cramps, nausea or vomiting
  • Fast, pounding, or uneven heartbeat
  • Lightheadedness, dizziness, fainting
  • Shaking, trembling, sweating, hunger, confusion, weakness
  • Swelling in your hands, ankles, or feet
  • Trouble breathing
  • Vaginal bleeding

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite
• Diarrhea
• Headache
• Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088