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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(mi FE pris tone)
Generic Available (U.S.)
No
Index Terms
Medication Guide
An FDA-approved patient medication guide, which is available with the product and as follows, must be dispensed with this medication:
Korlym™http://www.fda.gov/downloads/Drugs/DrugSafety/UCM294245.pdf
Mifeprex®: http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf
REMS Components
Elements to Assure Safe Use; Implementation System; Medication Guide
Prescribing and Access Restrictions
Mifeprex®: As a requirement of the REMS program, a medication guide must be given to the patient prior to receiving the medication. In addition, the manufacturer recommends distributing a patient agreement form which must be signed by the patient and prescriber confirming the patient's agreement to terminate her pregnancy. A signed copy of the patient agreement should be kept in the patient's medical record.
Mifeprex® is only available direct from Danco Laboratories' distributor. To obtain the product, please refer to, http://www.earlyoptionpill.com, or call 1-877-432-7596.
Investigators wishing to obtain the agent for use in oncology patients must apply for a patient-specific IND from the FDA.
Brand Names: U.S.
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Korlym™: To control hyperglycemia occurring secondary to hypercortisolism in patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and who failed surgery or who are not surgical candidates
Mifeprex®: Medical termination of intrauterine pregnancy, through day 49 of pregnancy. Patients may need treatment with misoprostol and possibly surgery to complete therapy.
Use: Unlabeled
Treatment of unresectable meningioma; has been studied in the treatment of breast cancer and ovarian cancer; termination of pregnancy ≤63 days of pregnancy
Pregnancy Risk Factor
X
Pregnancy Considerations
Use of mifepristone in a pregnant woman will result in fetal loss. In addition, skull deformities were observed in rabbit reproduction studies and were most likely due to uterine contractions. Korlym™: [U.S. Boxed Warning]: Use of mifepristone will result in termination of pregnancy. When used to control hyperglycemia in women with Cushing's syndrome, pregnancy must be excluded prior to initiation of therapy. Nonhormonal contraception must be used during treatment and for 1 month after discontinuation of therapy unless the patient has had surgical sterilization. Pregnancy must be excluded if treatment is interrupted for ≥14 days.Mifeprex®: This medication is used to terminate pregnancy; there are no approved treatment indications for its use during pregnancy. In addition, skull defects, cranial nerve palsies, delayed growth and psychomotor development, facial malformations and limb defects have been reported following prostaglandin exposure (including misoprostol). If treatment fails, there is a risk of fetal malformation. In sexually active women, pregnancy can occur prior to the first menstrual period following treatment. Appropriate contraception can be started as soon as termination of pregnancy is confirmed or before sexual intercourse is resumed.
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Mifepristone milk concentrations were evaluated in lactating women receiving a single dose for the termination of pregnancy. In women receiving mifepristone 200 mg (n=2), milk concentrations were below the limit of detection (<0.013 micromole/L) in samples collected over the following 5 days. The highest milk concentration following a single 600 mg dose (n=10) was 0.913 micromole/L on day 1 and concentrations decreased to 0.062 micromole/L by day 5. Using the highest reported milk concentration, the authors calculated the relative infant dose to be ≤1.5% of the weight adjusted maternal dose in a fully breastfed infant (Sääv, 2010).
When using this medication for termination of pregnancy, the manufacturer recommends that breast milk be discarded for a few days following the last dose. When using for the treatment of hyperglycemia in women with Cushing's syndrome, the manufacturer recommends that the decision to continue or discontinue breast-feeding during therapy take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Contraindications
Hypersensitivity to mifepristone or any component of the formulation
Korlym™ (additional contraindications): Concomitant use of lovastatin, simvastatin, or CYP3A substrates with a narrow therapeutic range (eg, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinine, sirolimus, tacrolimus); concomitant use of systemic corticosteroids for serious medical conditions (eg, immunosuppression following organ transplant); women with a history of unexplained vaginal bleeding, or endometrial hyperplasia with atypia or endometrial carcinoma; pregnancy
Mifeprex® (additional contraindications): Hypersensitivity to misoprostol; chronic adrenal failure; porphyrias; hemorrhagic disorder or concurrent anticoagulant therapy; pregnancy termination >49 days; intrauterine device (IUD) in place; ectopic pregnancy or undiagnosed adnexal mass; concurrent long-term corticosteroid therapy; inadequate or lack of access to emergency medical services; inability to understand effects and/or comply with treatment
Warnings/Precautions
Boxed warnings:
• Bacterial infections: See “Concerns related to adverse effects” below.
• Bleeding: See “Concerns related to adverse effects” below.
• Medication guide: See “Other warnings/precautions” below.
• Patient education: See “Other warnings/precautions” below.
• Pregnancy: See “Special populations” below.
Concerns related to adverse effects:
• Adrenal insufficiency: When used for the treatment of hyperglycemia in patients with Cushing's syndrome, adrenal insufficiency may occur. Serum cortisol concentrations remain elevated and may increase, and cannot be used for monitoring. If signs and symptoms of adrenal insufficiency occur (eg, fatigue, hypoglycemia, hypotension, nausea, weakness), discontinue mifepristone and administer glucocorticoids (high doses may be needed). Following resolution, treatment may be resumed at a lower dose; evaluate patient for precipitating causes (eg, infection, trauma).
• Bacterial infections: [U.S. Boxed Warning]: When used for the termination of pregnancy, bacterial infections have been reported following use of this product and may have an atypical presentation. In rare cases, these infections may be serious and/or fatal, with septic shock as a potential complication. A causal relationship has not been established. Sustained fever, abdominal pain, or pelvic tenderness should prompt evaluation; however, healthcare professionals are warned that atypical presentations of serious infection without these symptoms have also been noted. Patients presenting with nausea, vomiting, diarrhea, or weakness, with or without abdominal pain or fever, should be evaluated for serious bacterial infection when symptoms occur >24 hours after taking misoprostol. Treatment with antibiotics, including coverage for anaerobic bacteria (eg, Clostridium sordellii) should be initiated. Patients with Cushing's syndrome may be at risk for opportunistic infections such as Pneumocystis jiroveci pneumonia.
• Bleeding: Regardless of indication, endometrial proliferation is promoted by mifepristone, resulting in endometrial thickening, cystic dilation of endometrial glands, and vaginal bleeding. [U.S. Boxed Warning]: When used for the termination of pregnancy, patients should be counseled to seek medical attention in cases of excessive bleeding. Bleeding occurs and should be expected (average 9-16 days, may be ≥30 days). In some cases, bleeding may be prolonged and heavy and may be a sign of incomplete abortion or other complications, potentially leading to hypovolemic shock; the manufacturer cites soaking through 2 thick sanitary pads per hour for 2 consecutive hours as an example of excessive bleeding. Bleeding may require blood transfusion (rare), curettage, saline infusions, and/or vasoconstrictors. Patients should be instructed to seek medical attention if prolonged heavy vaginal bleeding occurs. When used for termination of pregnancy, use is contraindicated in women with hemorrhagic disorders or those using anticoagulants; use caution in women with severe anemia, hypocoagulability or hemostatic disorders. When used for the treatment of hyperglycemia in patients with Cushing's syndrome, use caution in women with hemorrhagic disorders or women using anticoagulants and evaluate unexplained vaginal bleeding; use is contraindicated with a history of unexplained vaginal bleeding.
• Hypokalemia: May occur at any time during therapy when used to control hyperglycemia in patients with Cushing's syndrome. Correct hypokalemia prior to initiation of treatment; monitor potassium levels closely with therapy.
• QT prolongation: May prolong the QTc interval (dose related); use caution with other QT-prolonging agents.
Disease-related concerns:
• Cardiovascular disease: When used for the termination of pregnancy, safety and efficacy have not been established for use in women with chronic cardiovascular disease as well as hypertension. Because mifepristone does not reduce serum cortisol concentrations, mineralocorticoid receptors in cardiac tissue may be activated; use caution in patients with Cushing's syndrome who also have heart failure or coronary vascular disease.
• Diabetes: Safety and efficacy have not been established for use in insulin-dependent diabetes mellitus.
• Hepatic impairment: In patients with moderate hepatic impairment, a large variability in exposure to mifepristone and its metabolites was observed at doses of 600 mg/day. Safety and efficacy have not been established for use in women with hepatic impairment when used as a single dose for the termination of pregnancy.
• Renal impairment: In patients with severe renal impairment, exposure to mifepristone and its metabolites was increased and a large variability in exposure was observed following multiple doses used in patients with Cushing's syndrome. Safety and efficacy have not been established for use in women with renal impairment when used as a single dose for the termination of pregnancy.
• Respiratory disease: Safety and efficacy have not been established for use in women with respiratory disease when used as a single dose for the termination of pregnancy.
Concurrent drug therapy issues:
• Corticosteroids: Use of mifepristone for the treatment of hyperglycemia in patients with Cushing's syndrome may antagonize the effects of steroids used for other conditions. Use is contraindicated when steroids are required for lifesaving indications.
• High potential for drug interactions: High potential for drug interactions exists when used for the treatment of hyperglycemia in patients with Cushing's syndrome. Refer to drug interactions for detailed information. The potential for drug interactions was not specifically studied following a single dose for the termination of pregnancy.
Special populations:
• Pregnancy: [U.S. Boxed Warning]: Use of mifepristone will result in termination of pregnancy. When used to control hyperglycemia in women with Cushing's syndrome, pregnancy must be excluded prior to initiation of therapy. Nonhormonal contraception must be used during treatment and for 1 month after discontinuation of therapy unless the patient has had surgical sterilization. Pregnancy must be excluded if treatment is interrupted for ≥14 days.
• Smokers: Use with caution in patients who are heavy smoker (>10 cigarettes/day); these patients were excluded from clinical trials when used as a single dose for the termination of pregnancy.
• Women >35 years: Use with caution in women >35 years of age; these patients were excluded from clinical trials when used as a single dose for the termination of pregnancy.
Other warnings/precautions:
• Confirmation of terminated pregnancy: When used for the termination of pregnancy, confirmation of pregnancy termination by clinical exam or ultrasound must be made 14 days following treatment. Manufacturer recommends surgical termination of pregnancy when medical termination fails or is not complete. Prescriber should determine in advance whether they will provide such care themselves or through other providers. Preventative measures to prevent rhesus immunization must be taken prior to surgical abortion.
• Ectopic pregnancy: Ultrasound should be used if an ectopic pregnancy is suspected or if duration of pregnancy is uncertain. Ultrasonography may not identify all ectopic pregnancies, and healthcare providers should be alert for signs and symptoms which may be related to undiagnosed ectopic pregnancy in any patient who receives mifepristone. Mifepristone is not effective in terminating ectopic pregnancies.
• Experienced physician: When used for the termination of pregnancy, to be administered only by physicians who can date pregnancy, diagnose ectopic pregnancies, provide access to surgical abortion (if needed), and can provide access to emergency care. Medication will be distributed directly to these physicians following signed agreement with the distributor. Must be administered under supervision by the qualified physician.
• Medication guide: [U.S. Boxed Warning]: When used for the termination of pregnancy, patients undergoing treatment with mifepristone should be instructed to bring their medication guide with them when an obtaining treatment from an emergency room or healthcare provider that did not prescribe the medication initially in order to identify that they are undergoing a medical abortion.
• Patient education: [U.S. Boxed Warning]: When used for the termination of pregnancy, patient must be instructed of the treatment procedure and expected effects. A signed agreement form must be kept in the patient's file. Physicians may obtain patient agreement forms, physician enrollment forms, and medical consultation directly from Danco Laboratories at 1-877-432-7596. Prescriber should also give the patient clear instructions on whom to call and what to do in the event of an emergency following administration of therapy.
• Pregnancy dating: Pregnancy is dated from day 1 of last menstrual period (presuming a 28-day cycle, ovulation occurring midcycle). Pregnancy duration can be determined using menstrual history and clinical examination. Ultrasound should be used if duration of pregnancy is uncertain.
• Reporting of adverse effects: When used for the termination of pregnancy, adverse effects (including blood transfusions, hospitalization, ongoing pregnancy, and other major complications) must be reported in writing to the medication distributor.
Adverse Reactions
Adverse events associated with treatment of hyperglycemia in patients with Cushing's syndrome:
>10%:
Cardiovascular: Peripheral edema (26%), hypertension (24%)
Central nervous system: Fatigue (48%), headache (44%), dizziness (22%), pain (14%)
Endocrine & metabolic: Hypokalemia (34% to 44%), endometrial hypertrophy (38%), thyroid function tests abnormal (18%)
Gastrointestinal: Nausea (48%), vomiting (26%), appetite decreased (20%), xerostomia (18%), diarrhea (12%)
Genitourinary: Vaginal bleeding (14%)
Neuromuscular & skeletal: Arthralgia (30%), back pain (16%), myalgia (14%), extremity pain (12%)
Respiratory: Dyspnea (16%), sinusitis (14%), nasopharyngitis (12%)
5% to 10%:
Cardiovascular: Edema, pitting edema
Central nervous system: Anxiety (10%), somnolence (10%), insomnia, malaise
Endocrine & metabolic: Hypoglycemia, triglycerides increased
Gastrointestinal: Anorexia (10%), constipation (10%), abdominal pain, GI reflux
Genitourinary: Vaginal hemorrhage, metrorrhagia
Neuromuscular & skeletal: Flank pain, malaise, musculoskeletal chest pain, weakness
Miscellaneous: Thirst
<5% or frequency not defined: Adrenal insufficiency (4%), pruritus (4%), rash (4%), HDL cholesterol decreased
Adverse events associated with treatment for termination of pregnancy: Note: Vaginal bleeding and uterine cramping are expected to occur when this medication is used to terminate a pregnancy; ~90% of women using this medication for this purpose also report adverse reactions on day 3 after the procedure. Bleeding or spotting occurs in most women for a period of 9-16 days. Up to 8% of women will experience some degree of bleeding or spotting for 30 days or more. In some cases, bleeding may be prolonged and heavy, potentially leading to hypovolemic shock.
>10%:
Central nervous system: Headache (2% to 31%), dizziness (1% to 12%)
Gastrointestinal: Abdominal pain (cramping) (96%), nausea (43% to 61%), vomiting (18% to 26%), diarrhea (12% to 20%)
Genitourinary: Uterine cramping (83%)
1% to 10%:
Cardiovascular: Syncope (1%)
Central nervous system: Fatigue (10%), fever (4%), insomnia (3%), anxiety (2%), fainting (2%)
Gastrointestinal: Dyspepsia (3%)
Genitourinary: Uterine hemorrhage (5%), vaginitis (3%), pelvic pain (2%), endometriosis/salpingitis/pelvic inflammatory disease (1%)
Hematologic: Decreased hemoglobin >2 g/dL (6%), anemia (2%), leukorrhea (2%)
Neuromuscular & skeletal: Back pain (9%), rigors (3%), leg pain (2%), weakness (2%)
Respiratory: Sinusitis (2%)
Miscellaneous: Viral infection (4%)
<1%: Significant ALT/AST, alkaline phosphatase, and GT changes have been reported rarely
Postmarketing and/or case reports: Adult respiratory distress syndrome (ADRS), allergic reaction including urticaria and hives, bacterial infection (including an ectopic bacteria such as Clostridium sordellii), Crohn's disease (exacerbation), disseminated intravascular coagulopathy (DIC), dyspnea, hematometra, hypotension, lightheadedness, loss of consciousness, MI, pancreatitis (acute), pelvic infection, postabortal infection, QT prolongation, ruptured ectopic pregnancy, sepsis, septic shock, sickle cell crisis (exacerbation), tachycardia, toxic shock syndrome
Unresectable meningioma trials: Most common adverse effects included breast tenderness or gynecomastia, fatigue, hair thinning, hot flashes, and rash. In premenopausal women, vaginal bleeding may be seen shortly after beginning therapy and cessation of menses is common. Thyroiditis and effects related to antiglucocorticoid activity have also been noted.
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BCRP, CYP1A2 (weak), CYP2A6 (weak), CYP2B6 (weak), CYP2C19 (weak), CYP2C8 (weak), CYP2C9 (weak), CYP2D6 (weak), CYP2E1 (weak), CYP3A4 (weak), P-glycoprotein
Drug Interactions
ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole systemic exposure/affects with concomitant use of a weak CYP3A4 inhibitor. Decrease aripiprazole dose to 25% of the usual dose in patients receiving both a CYP3A4 and a CYP2D6 inhibitor (regardless of potencies). Risk C: Monitor therapy
ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult product labeling for specific recommendations. Risk C: Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Grapefruit juice may inhibit mifepristone metabolism, leading to increased levels. Management: Do not take with grapefruit juice.
Herb/Nutraceutical: St John's wort may induce mifepristone metabolism, leading to decreased levels. Management: Avoid St John's wort.
Storage
Store at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86 °F).
Mechanism of Action
Mifepristone is a synthetic steroid. At low doses, it competitively binds to the intracellular progesterone receptor, blocking the effects of progesterone. When used for the termination of pregnancy, this leads to contraction-inducing activity in the myometrium. In the absence of progesterone, mifepristone acts as a partial progesterone agonist. At high doses used for the treatment of hyperglycemia in patients with Cushing's syndrome, mifepristone blocks the effect of cortisol at the glucocorticoid receptor (antagonizes the effects of cortisol on glucose metabolism) while at the same time increasing circulating cortisol concentrations.
Pharmacodynamics/Kinetics
Absorption: Oral: rapid
Protein binding: 98% to albumin and α1-acid glycoprotein
Metabolism: Hepatic via CYP3A4 to three metabolites (active)
Bioavailability: Oral: 69%
Half-life elimination: Single dose: Terminal: 18 hours following a slower phase where 50% eliminated between 12-72 hours; Multiple doses (600 mg/day): 85 hours
Time to peak: Oral: 90 minutes; Range: Single dose: 1-2 hours, Multiple doses: 1-4 hours
Excretion: Feces (83%); urine (9%)
Dosage
Oral:
Adults:
Hyperglycemia in patients with Cushing's syndrome: Initial dose: 300 mg once daily. Dose may be increased in 300 mg increments at intervals of ≥2-4 weeks based on tolerability and symptom control. Maximum dose: 1200 mg once daily, not to exceed 20 mg/kg/day. If treatment is interrupted, reinitiate at 300 mg/day or a dose lower than the dose that caused the treatment to be stopped if interruption due to adverse reactions
Dosage adjustment with concurrent use of strong CYP450 inhibitor therapy (eg ketoconazole): Maximum dose 300 mg/day
Termination of pregnancy: Treatment consists of 3 office visits by the patient; the patient must read medication guide and sign patient agreement prior to treatment:
Day 1: 600 mg (three 200 mg tablets) taken as a single dose under physician supervision
Day 3: Patient must return to the healthcare provider 2 days following administration of mifepristone; unless abortion has occurred (confirmed using ultrasound or clinical examination): 400 mcg (two 200 mcg tablets) of misoprostol; patient may need treatment for cramps or gastrointestinal symptoms at this time
Day 14: Patient must return to the healthcare provider ~14 days after administration of mifepristone; confirm complete termination of pregnancy by ultrasound or clinical exam. Surgical termination is recommended to manage treatment failures.
Termination of pregnancy (unlabeled dosing): Mifepristone 200 mg orally, followed by misoprostol 800 mcg vaginally 24-48 hours later (ACOG, 2005; FIGO, 2011)
Meningioma, unresectable (unlabeled use; refer to individual protocols): 200 mg/day, continue based on toxicity and response (Grunberg, 1991)
Elderly: Hyperglycemia in patients with Cushing's syndrome: Refer to adult dosing.
Dosage adjustment in renal impairment:
Hyperglycemia in patients with Cushing's syndrome: Maximum dose 600 mg/day; Note: Following doses of 1200 mg/day for 7 days in patients with severe renal impairment (Clcr <30 mL/minute), exposure to mifepristone and its metabolites was increased and a large variability in exposure was observed.
Termination of pregnancy: No dosage adjustment provided in manufacturer's labeling (has not been studied)
Dosage adjustment in hepatic impairment:
Hyperglycemia in patients with Cushing's syndrome:
Mild-to-moderate impairment: Maximum dose 600 mg/day
Severe impairment: Use is not recommended
Note: Following single and multiple doses of 600 mg/day in patients with moderate hepatic impairment (Child-Pugh Class B), a large variability in exposure to mifepristone and its metabolites was observed.
Termination of pregnancy: No dosage adjustment provided in manufacturer's labeling (has not been studied); use with caution due to CYP3A4 metabolism.
Administration: Oral
Hyperglycemia in patients with Cushing's syndrome: Administer as a single daily dose with a meal. Tablets should be swallowed whole, not crushed, split, or chewed.
Termination of pregnancy: To be taken as a single dose under physician supervision
Monitoring Parameters
Treatment of hyperglycemia in patients with Cushing's syndrome: Signs and symptoms of adrenal insufficiency (serum cortisol concentrations will not be accurate); thyroid function; serum potassium (1-2 weeks after initiating dose or dose increase, then periodically thereafter); serum glucose and psychiatric symptoms (may show response to therapy within 6 weeks); cushingoid appearance (acne, hirsutism, striae, weight may take >2 months of therapy to show improvement); vaginal ultrasound in women (annually)
Termination of pregnancy: Clinical exam and/or ultrasound to confirm complete termination of pregnancy; hemoglobin, hematocrit, and red blood cell count in cases of heavy bleeding. Consider CBC in any patient who reports nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after administration of misoprostol.
Test Interactions
hCG levels will not be useful to confirm pregnancy termination until at least 10 days following mifepristone treatment
When used for the treatment of hyperglycemia in patients with Cushing's syndrome, serum cortisol concentrations remain elevated and may increase, and cannot be used for monitoring.
Patient Education
Mifeprex®: This medication is used to terminate pregnancy under 7 weeks. It must be administered under direction of a qualified physician. You will need follow-up visits as directed by your prescriber (approximately 3 days and 14 days after treatment). Surgical termination of pregnancy may be required if medication fails; there is a risk of fetal malformation if treatment fails. You may experience vaginal bleeding and cramping that is heavier than a normal menstrual period; report immediately if severe or persistent. You may experience nausea, vomiting, and diarrhea. It is possible to get pregnant before your next period. Once the pregnancy has proved to be ended, contraception should be started before having sexual intercourse.
Additional Information
Mifeprex®: Medication will be distributed directly to qualified physicians following signed agreement with the distributor, Danco Laboratories. It will not be available through pharmacies. Major adverse reactions (hospitalization, blood transfusion, ongoing pregnancy, etc) should be reported to Danco Laboratories.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause dizziness, fatigue, insomnia, or anxiety
Mental Health: Effects on Psychiatric Treatment
Gastrointestinal side effects are common; use caution with lithium, valproic acid, and SSRIs. Fluoxetine, fluvoxamine, and nefazodone may increase mifepristone serum levels and/or toxicity; monitor. Carbamazepine, phenobarbital, and St John's wort may increase the metabolism of mifepristone, resulting in decreased mifepristone levels and/or effect; monitor.
Nursing: Physical Assessment/Monitoring
May only be administered under supervision of a qualified physician. Patient must be instructed in procedure and sign patient consent forms. Monitor for excessive bleeding. Monitor vital signs.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, oral:
Mifeprex®: 200 mg
References
ACOG, ACOG Practice Bulletin, Clinical Management Guidelines of Obstetrician-Gynecologists, Number 67, October 2005, "Medical Management of Abortion," Obstet Gynecol, 2005, 106(4):871-82.
FIGO Working Group on Prevention of Unsafe Abortion and its Consequences, "The Combination of Mifepristone and Misoprostol for the Termination of Pregnancy," Int J Gynaecol Obstet, 2011, 115(1):1-4.
Fischer M, Bhatnagar J, Guarner J, et al, "Fatal Toxic Shock Syndrome Associated With Clostridium sordellii After Medical Abortion," N Engl J Med, 2005, 353(22):2352-60.
Gary MM and Harrison DJ, "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," Ann Pharmacother, 2006, 40(2):191-7.
Grunberg SM, Weiss MH, Spitz IM, et al, “Treatment of Unresectable Meningiomas With the Antiprogesterone Agent Mifepristone,” J Neurosurg, 1991, 74(6):861-6.
Johanssen S and Allolio B, "Mifepristone (RU 486) in Cushing's Syndrome," Eur J Endocrinol, 2007, 157(5):561-9.
Perrault D, Eisenhauer EA, Pritchard KI, et al, “Phase II Study of the Progesterone Antagonist Mifepristone in Patients With Untreated Metastatic Breast Carcinoma: A National Cancer Institute of Canada Clinical Trials Group Study,” J Clin Oncol, 1996, 14(10):2709-12.
Rocereto TF, Saul HM, Aikins JA, et al, “Phase II Study of Mifepristone (RU486) in Refractory Ovarian Cancer,” Gynecol Oncol, 2000, 77(3):429-32.
Sääv I, Fiala C, Hämäläinen JM, et al, "Medical Abortion in Lactating Women -- Low Levels of Mifepristone in Breast Milk," Acta Obstet Gynecol Scand, 2010, 89(5):618-22.
Spitz IM and Bardin CW, “Mifepristone (RU486) - A Modulator of Progestin and Glucocorticoid Action,” N Engl J Med, 1993, 329(6):404-12.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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