When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mifepristone, misoprostol, or similar medicines, or if you have abnormal vaginal bleeding, endometrial cancer, a bleeding disorder, or porphyria. Patients with Cushing syndrome should not use this medicine if they are pregnant.

How to Use This Medicine:
Tablet

• Mifeprex® tablets:
  
  • The entire treatment requires 3 visits to your doctor.
  • At the first visit, you will be given 1 mifepristone tablet. Two days later at the second visit, you will be given 4 tablets of another medicine called misoprostol. Two weeks later at the third visit, your doctor will check to make sure you are no longer pregnant. It is very important that you go to all of your appointments during your treatment. Call your doctor if you are not able to keep one of your appointments.
  • This medicine will cause you to bleed and have cramps for about 2 to 4 weeks.
• Korlym™ tablets:
  
  • 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 break, 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 if you are also using a blood thinner (including warfarin), cyclosporine, dihydroergotamine, ergotamine, fentanyl, lovastatin, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, 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:
  
  • Aprepitant, boceprevir, bupropion, carbamazepine, conivaptan, diltiazem, fluvastatin, imatinib, mibefradil, nefazodone, repaglinide, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St John's wort, telaprevir, or verapamil
  • Medicine to treat HIV/AIDS (including amprenavir, atazanavir, darunavir/ritonavir, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat an infection (including ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole)
  • 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:

• Mifeprex® tablets:
  
  • Tell your doctor if you are breastfeeding, or if you have adrenal gland problems, a 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 severe infection or excessive 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.
• Korlym™ tablets:
  
  • 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. Use an effective form of birth control during treatment and for 1 month after treatment ends.
  • Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, a bleeding disorder, heart failure, high blood pressure, or a history of heart or blood vessel disease.
  • This medicine could cause the following problems:
    
    • Adrenal insufficiency
    • Low potassium levels in the blood
    • Vaginal bleeding
    • QT prolongation (heart rhythm problem)
• 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
• Mifeprex® tablets:
  
  • Fever, severe stomach pain, or pelvic tenderness
  • Heavy vaginal bleeding or severe cramping
• Korlym™ tablets:
  
  • Dry mouth, increased thirst, muscle cramps
  • 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:

• Joint or muscle pain
• Decreased appetite
• Diarrhea, nausea, vomiting
• Headache
• Tiredness

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