Adult Dosing
Early termination of pregnancy
- Day 1: 600 mg PO as a single dose
- Day 3: Misoprostol 400 mcg PO; unless abortion has been confirmed by clinical or ultrasonographic examination
- Day 14: Follow-up visit to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred
Notes- Patient must be <49 days away from 1st day of last menstrual period
Hyperglycemia secondary to hypercortisolism in Cushing's syndrome
- 300 mg PO qd
- Max: 1200 mg PO qd but should not exceed 20 mg/kg per day
Notes:- Dose increases should not occur more frequently than once every 2-4 weeks
- Take dose with meal. Do not split, crush, or chew tablets
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Severe vaginal bleeding may occur following spontaneous, surgical, or medical abortion. Prolonged heavy vaginal bleeding may be a sign of incomplete abortion or other complications. Prompt medical/surgical intervention may be required [US Black Box Warning]
- If excessive vaginal bleeding occurs, use uterotonics, vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions
- Serious bacterial infections, including very rare cases of fatal septic shock, have occurred. Sustained fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness may be an indication of infection [US Black Box Warning]
- Patients with serious bacterial infections and sepsis may present without fever, bacteremia, or significant findings on pelvic examination post-abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis [US Black Box Warning]
- Follow-up visit at approximately 14 days with physician to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred and to assess the degree of bleeding
- Contraindicated in confirmed or suspected ectopic pregnancy. Before prescribing mifepristone, patient should undergo ultrasonography to avoid the presence of ectopic pregnancy
- Mifepristone should be administered only in a clinic, medical office, or hospital, by or under the supervision of a qualified physician, experienced in assessing gestational age and diagnosis of ectopic pregnancies
- Safety and efficacy have not been established in patients with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking
- Patients who have been administered with mifepristone may experience adrenal insufficiency. Monitor closely for signs and symptoms of adrenal insufficiency including weakness, nausea, increased fatigue, hypotension, and hypoglycemia
- Discontinue the treatment if adrenal insufficiency is suspected and administer glucocorticoids
- Hypokalemia has been reported during treatment with mifepristone, correct hypokalemia before initiating mifepristone. Measure serum potassium 1 to 2 weeks after initiating or increasing the dose and periodically thereafter. Consider intravenous or oral potassium supplementation treatment based on event severity, if still hypokalemia persist treat with mineralocorticoid antagonists
- Therapy may cause QTc prolongation, Avoid mifepristone with QT interval prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval
- Use cautiously in patients receiving ketoconazole and other strong inhibitors of CYP3A as it may increase the concentration of mifepristone in the blood
- Therapy may increase the risk of opportunistic infections such as pneumocystis jiroveci pneumonia in patients with Cushing’s syndrome. Perform diagnostic tests and appropriate treatment for pneumocystis jiroveci
Cautions: Use cautiously in
- Chronic medical conditions
- Women >35 yrs who smoke
10 cigarettes/day - Cardiovascular disease
- Hepatic impairment
- Renal impairment
- Respiratory disease
Pregnancy Category:X
Breastfeeding: Safety unknown. Limited information indicates that breastfeeding need not be interrupted after a single dose of mifepristone. A dose of 200 mg might be preferable to a 600 mg dose in nursing mothers. This information based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 12 February 2011). As per the manufacturer's data, nursing women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.
