Mifepristone (Oral Route)

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Mifeprex® tablets in pregnant women younger than 17 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Korlym™ tablets in the pediatric population. Safety and efficacy have not been established.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal vaginal bleeding, history of or
• Adrenal failure, chronic or
• Bleeding problems or
• Ectopic pregnancy (eg, a pregnancy that develops in fallopian tubes instead of the uterus) or
• Endometrial hyperplasia or cancer or
• Lower abdominal mass that is undiagnosed or
• Porphyria (an enzyme problem)—Should not be used in patients with these conditions.

• Adrenal problems or
• Autoimmune disorders or
• Diabetes or
• Heart failure or
• Heart or blood vessel disease (eg, coronary vascular disease) or
• Heart rhythm problem (eg, QT prolongation) or
• Hypertension (high blood pressure) or
• Lung disease—Use with caution. May make these conditions worse.

• Anemia, severe or
• Inability of blood to clot properly or
• Poor blood circulation—Mifeprex® causes heavy bleeding in a small portion of users, this may be intensified in patients with bleeding disorders.

• Hypokalemia (low potassium in the blood)—Should be corrected first before using this medicine.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For termination of pregnancy (70 days or less) taken together with misoprostol:
    • Adults—200 milligrams (mg) as a single dose on Day 1. This is followed 2 days later by 800 micrograms (mcg) (four-200 mcg tablets) of misoprostol as a single dose placed in the cheeks.
    • Children—Use is not recommended.
  • For treatment of hyperglycemia in patients with Cushing's syndrome:
    • Adults—At first, 300 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1200 mg per day.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.