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Korlym Generic Name & Formulations
Legal Class
Rx
General Description
Mifepristone 300mg; tabs.
Pharmacological Class
Cortisol receptor blocker.
How Supplied
Tabs—28, 280
Manufacturer
Generic Availability
NO
Korlym Indications
Indications
To control hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Limitations of Use
Not for treatment of type 2 diabetes unless secondary to Cushing’s syndrome.
Korlym Dosage and Administration
Adult
Swallow whole. Take with food. Initially 300mg once daily. May increase in 300mg increments (once every 2–4 weeks) to a max of 1200mg once daily, based on response and tolerability. Max: 20mg/kg per day. Renal or mild-to-moderate hepatic impairment: max 600mg once daily. Severe hepatic impairment: not recommended. Concomitant strong CYP3A4 inhibitors (if necessary): max 900mg once daily; see full labeling.
Children
Not established.
Korlym Contraindications
Contraindications
Pregnancy. Currently taking simvastatin, lovastatin, or CYP3A substrates with narrow therapeutic range (eg, cyclosporine, ergots, fentanyl, pimozide, quinidine, sirolimus, tacrolimus). Concomitant long-term corticosteroids for serious conditions/illnesses. Women with endometrial hyperplasia with atypia, endometrial carcinoma, or history of unexplained vaginal bleeding.
Korlym Boxed Warnings
Not Applicable
Korlym Warnings/Precautions
Warnings/Precautions
Exclude pregnancy before the initiation or treatment interruption for >14 days. Females of reproductive potential should use non-hormonal contraceptives during and for 1 month after discontinuing treatment. Monitor for adrenal insufficiency; discontinue and treat if suspected; resume therapy at lower dose after resolution. Correct hypokalemia prior to treatment. Measure serum potassium 1–2 weeks after initiation, during dose increases, and periodically thereafter. Risk of QT interval prolongation or opportunistic infections (eg, Pneumocystis jiroveci pneumonia). Avoid in patients with potassium channel variants resulting in a long QT interval. Underlying heart conditions (including heart failure, coronary vascular disease). Women who have hemorrhagic disorders or receiving concurrent anticoagulant therapy. Renal or hepatic impairment. Nursing mothers: not recommended (may consider pumping and discarding milk during and for 18–21 days after the last dose).
Korlym Pharmacokinetics
See Literature
Korlym Interactions
Interactions
See Contraindications. Avoid initiating or increasing the dose of any interacting concomitant drugs after discontinuing Korlym for at least 2 weeks. Avoid concomitant CYP3A inducers (eg, rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, St. John’s wort) or QT interval-prolonging drugs. Potentiated by strong CYP3A inhibitors (eg, ketoconazole, itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir/ritonavir, posaconazole, saquinavir, telithromycin, voriconazole); caution, if co-admin necessary; limit dose to 900mg/day (see Adults). Potentiates CYP2C8/2C9 substrates (eg, fluvastatin, NSAIDs, warfarin, repaglinide); use lower dose of these and monitor closely. Caution with drugs that are metabolized by CYP2B6 (eg, bupropion, efavirenz). Antagonizes hormonal contraceptives.
Korlym Adverse Reactions
Adverse Reactions
Nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy.
Korlym Clinical Trials
See Literature
Korlym Note
Not Applicable
Korlym Patient Counseling
See Literature
