vemurafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.venetoclaxSerious - Use Alternative (1)mifepristone will increase the level or effect of venetoclax by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.venlafaxineMonitor Closely (1)mifepristone will increase the level or effect of venlafaxine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.verapamilMonitor Closely (2)verapamil will increase the level or effect of mifepristone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. mifepristone will increase the level or effect of verapamil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.vilanterol/fluticasone furoate inhaledSerious - Use Alternative (2)mifepristone will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. mifepristone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.vilazodoneMonitor Closely (1)mifepristone will increase the level or effect of vilazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. If intolerable adverse effects occur when coadministered with moderate CYP3A4 inhibitors, reduce vilazodone to 20 mg/dayvinblastineMonitor Closely (1)mifepristone will increase the level or effect of vinblastine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.vincristineMonitor Closely (1)mifepristone will increase the level or effect of vincristine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.vincristine liposomalMonitor Closely (1)mifepristone will increase the level or effect of vincristine liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.vinorelbineMonitor Closely (1)mifepristone will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.voclosporinContraindicated (1)mifepristone will increase the level or effect of voclosporin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.Monitor Closely (1)voclosporin, mifepristone. Either increases effects of the other by QTc interval. Use Caution/Monitor.vorapaxarMonitor Closely (1)mifepristone will increase the level or effect of vorapaxar by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.voriconazoleMonitor Closely (1)voriconazole will increase the level or effect of mifepristone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Do not exceed mifepristone 300 mg/day for Cushing syndrome when coadministered with strong CYP3A4 inhibitors; combination may also prolong QT interval. Use alternatives if availableSerious - Use Alternative (1)mifepristone will increase the level or effect of voriconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.vorinostatMonitor Closely (1)mifepristone, vorinostat. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.vortioxetineMonitor Closely (1)mifepristone will increase the level or effect of vortioxetine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.voxelotorSerious - Use Alternative (1)voxelotor will increase the level or effect of mifepristone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.warfarinContraindicated (1)mifepristone increases effects of warfarin by anticoagulation. Contraindicated.zanubrutinibMonitor Closely (1)mifepristone will increase the level or effect of zanubrutinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce zanubrutinib (a CYP3A4 substrate) to 80 mg PO BID when coadministered with a moderate CYP3A4 inhibitor. Interrupt dose as recommended for adverse reactions. After discontinuing the CYP3A4 inhibitor, resume previous zanubrutinib dose. ziprasidoneMonitor Closely (1)mifepristone, ziprasidone. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.zolpidemMonitor Closely (1)mifepristone will increase the level or effect of zolpidem by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. >10% (Mifeprex) Abdominal pain, cramping (96%) Uterine cramping (83%) Nausea (43-61%) Headache (2-31%) Vomiting (1-26%) Diarrhea (12-20%) Dizziness (1-12%) >10% (Korlym) 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%) Postmarketing reports Angioedema 1-10% (Mifeprex) Fatigue (10%) Back pain (9%) Decreased hemoglobin >2 g/dL (6%) Uterine hemorrhage (5%) Viral infection (4%) Dyspepsia (3%) Insomnia (3%) Rigors (3%) Vaginitis (3%) Anemia (2%) Anxiety (2%) Fainting (2%) Leg pain (2%) Leukorrhea (2%) Pelvic pain (2%) Sinusitis (2%) Weakness (2%) 1-10% (Korlym) Constipation (10%) Somnolence (10%) Anorexia (10%) Anxiety (10%) Gastroesophageal reflux (5-10%) Abdominal pain (5-10%) Increased triglycerides (5-10%) Hypoglycemia (5-10%) Insomnia (5-10%) Vaginal hemorrhage, metrorrhagia (5-10%) General disorders: asthenia, malaise, edema, pitting edema, thirst (5-10%) Musculoskeletal and connective tissue disorders: muscular weakness, flank pain, musculoskeletal chest pain (5-10%) Adrenal insufficiency (4%) Rash (4%) Pruritus (4%) Black Box Warnings Mifeprex Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions Atypical presentation of infection reported; patients with serious bacterial infections (eg, Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination following an abortion; very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise Prolonged heavy bleeding may be a sign of incomplete abortion or other complications that requires prompt medical attention Should be used only with strict adherence to recommended dosages by medically trained personnel who can provide immediate intensive care in acute surgical facilities Korlym Potent antiprogestational effects and will result in the termination of pregnancy Pregnancy must therefore be excluded before the initiation of treatment with Korlym, or if treatment is interrupted for more than 14 days in females of reproductive potential Pregnancy must be prevented during treatment and for 1 month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization Contraindications Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins Mifeprex Confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, or IUD currently in place Chronic adrenal failure or concurrent long-term corticosteroid therapy Hemorrhagic disorders, inherited porphyrias, or concurrent anticoagulant therapy Concurrent long-term corticosteroid therapy Hypersensitivity to drug or components Inherited porphyrias Patients with intrauterine device (IUD) in place if terminating intrauterine pregnancy Korlym Pregnancy Coadministration with simvastatin or lovastatin and CYP3A substrates with narrow therapeutic range (eg, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) Patients requiring systemic corticosteroids for serious medical conditions Women with history of unexplained vaginal bleeding Women with endometrial hyperplasia with atypia or endometrial carcinoma Cautions Mifeprex A clinical examination or ultrasonographic scan should be performed approximately 14 days after mifepristone administration to confirm termination of pregnancy Preventive measures to suppress formation of anti-Rho(D) antibodies (eg, administration of Rho(D) immune globulin) should be considered in Rho (D)-negative women Use with caution in women <35 years who smoke 10 or more cigarettes daily Available only through a restricted program under a REMS called the mifepristone REMS Program, because of the risks of serious complications; prescribers must be certified and patients must sign a patient agreement form Must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers Infection and sepsis Any termination of pregnancy, including those resulting from mifepristone use, may result in serious, potentially fatal infections and bleeding (see Black Box Warnings) As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, reported following the therapy Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to possibility of this rare event; a sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be indication of infection A high index of suspicion is needed to rule out sepsis (eg, from Clostridium sordellii) if patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise No causal relationship between drug and misoprostol use and an increased risk of infection or death established Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions Uterine bleeding Uterine bleeding occurs in almost all patients during medical abortion; prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent development of hypovolemic shock Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days; women report experiencing heavy bleeding for a median duration of 2 days Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as duration of pregnancy increased Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in women who bleed heavily Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to < 0.1% of subjects Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia Ectopic pregnancy Contraindicated in patients with a confirmed or suspected ectopic pregnancy; drug is not effective for terminating ectopic pregnancies Healthcare providers should remain alert to possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed drug Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy REMS program Prescribers must be certified with the program by completing the Prescriber Agreement Form. Patients must sign a Patient Agreement Form. Drug must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers Further information is available at 1-877-4 Early Option (1-877-432-7596) Korlym Do not use for treatment of hyperglycemia unrelated to Cushing syndrome; patients with endogenous Cushing’s syndrome are at risk for opportunistic infections such as Pneumocystis jiroveci pneumonia during treatment; patients may present with respiratory distress shortly after initiation of therapy; appropriate diagnostic tests should be undertaken and treatment for Pneumocystis jiroveci should be considered Drug prolongs QTc interval in a dose-related manner; there is little or no experience with high exposure, concomitant dosing with other QT-prolonging drugs, or potassium channel variants resulting in a long QT interval; to minimize risk, the lowest effective dose should always be used Drug does not reduce serum cortisol levels; elevated cortisol levels may activate mineralocorticoid receptors which are also expressed in cardiac tissues; caution should be used in patients with underlying heart conditions including heart failure and coronary vascular disease Use of Korlym in patients who receive corticosteroids for other conditions (eg, autoimmune disorders) may lead to exacerbation or deterioration because of Korlym’s glucocorticoid antagonistic effects; for medical conditions in which chronic corticosteroid therapy is life-saving (eg, immunosuppression in organ transplantation), Korlym is contraindicated Coadministration with strong CYP3A inhibitors can increase mifepristone plasma levels significantly; use only when necessary and limit mifepristone dose to 300 mg (see Dosage Modification) Endometrial changes Being an antagonist of the progesterone receptor, mifepristone promotes unopposed endometrial proliferation that may result in endometrium thickening, cystic dilatation of endometrial glands, and vaginal bleeding Drug should be used with caution in women who have hemorrhagic disorders or are receiving concurrent anticoagulant therapy Women who experience vaginal bleeding during treatment should be referred to a gynecologist for further evaluation Adrenal insufficiency Patients receiving mifepristone may experience adrenal insufficiency Because serum cortisol levels remain elevated and may even increase during treatment, serum cortisol levels do not provide an accurate assessment of hypoadrenalism in patients receiving drug Patients should be closely monitored