Classes
DEA Class; Rx
Common Brand Names; Mifeprex, Korlym, ru486
- Antiprogestins;
- Cortisol Receptor Blockers
Description
Synthetic steroid with potent antiprogesterone and antiglucocorticoid activity; derivative of the synthetic progestin norethindrone
One product is used with a prostaglandin (e.g., misoprostol) as an abortifacent regimen via a restricted access program (Mifeprex)
Another product (Korlym) is used to treat hyperglycemia in adults with Cushing’s syndrome and is available via a limited distribution program since use is contraindicated during pregnancy
Indications
Contraindications
Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins
Adverse Effects
- Abdominal pain, cramping (96%)
- Uterine cramping (83%)
- Nausea (43-61%)
- Headache (2-31%)
- Vomiting (1-26%)
- Diarrhea (12-20%)
- Dizziness (1-12%)
- Fatigue (48%)
- Nausea (48%)
- Headache (44%)
- Endometrial hypertrophy (38%)
- Hypokalemia (34%)
- Arthralgia (30%)
- Vomiting (26%)
- Peripheral edema (26%)
- Hypertension (24%)
- Dizziness (22%)
- Decreased appetite (20%)
- Abnormal thyroid function test (18%)
- Xerostomia (18%)
- Back pain (16%)
- Dyspnea (16%)
- Myalgia (14%)
- Pain (14%)
- Sinusitis (14%)
- Nasopharyngitis (12%)
- Extremity pain (12%)
- Diarrhea (12%)
Warnings
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Pregnancy and Lactation
Drug contraindicated in pregnancy because use results in pregnancy loss; there are no data that assess risk of birth defects in women exposed to drug during pregnancy
Drug is present in human milk, however, there are no data on amount of mifepristone in human milk, effects on breastfed infant, or on milk production during long term use of mifepristone; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for Korlym and any potential adverse effects on breastfed child from drug or from the underlying maternal condition
Maximum Dosage
200 mg PO as a single dose is the FDA-approved maximum dose for termination of pregnancy; 1,200 mg/day PO for Cushing’s syndrome and not to exceed 20 mg/kg/day PO; otherwise maximum dose is dependent on the indication for use.
Safety and efficacy have not been established.
200 mg PO as a single dose is the FDA-approved maximum dose for termination of pregnancy; safety and efficacy have not been established for Cushing’s syndrome.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Mifepristone
tablet
- 200mg (Mifeprex)
- 300mg (Korlym)
