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Korlym is contraindicated in women who are pregnant. Pregnancy must be excluded before the initiation of treatment with Korlym or if treatment is interrupted for more than 14 days in females of reproductive potential. Nonhormonal contraceptives should be used during and one month after stopping treatment in all women of reproductive potential. [See Use in Specific Populations]
Drugs Metabolized By CYP3A
Korlym is contraindicated in patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [See DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]
Corticosteroid Therapy Required For Lifesaving Purposes
Korlym is contraindicated in patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation) because Korlym antagonizes the effect of glucocorticoids.
Women With Risk Of Vaginal Bleeding Or Endometrial Changes
Korlym is contraindicated in the following:
- Women with a history of unexplained vaginal bleeding
- Women with endometrial hyperplasia with atypia or endometrial carcinoma
Known Hypersensitivity To Mifepristone
Korlym is contraindicated in patients with prior hypersensitivity reactions to mifepristone or to any of the product components.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/24/2014
Additional Korlym Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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