Prescribing guide
Korlym (mifepristone)Pregnancy testing, potassium monitoring, titration, CYP3A limits and prior approval criteria for hyperglycemia in Cushing syndromeFor prescribers and their offices treating Cushing syndrome, including Cushing disease: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; boxed warning for termination of pregnancy; negative pregnancy test where it applies, non-hormonal contraception, hypokalemia corrected, a contraindicated-medicine review, prior approval, and a SPARK Patient Enrollment Form.
Example PA threshold
FEP example: age 18 or older, endogenous Cushing syndrome with type 2 diabetes or glucose intolerance, failed surgery or not a candidate, pregnancy exclusion agreed, no Child-Pugh C impairment.
Monitoring
Potassium before starting, 1 to 2 weeks after starting or each dose increase, then periodically; clinical signs of adrenal insufficiency (not serum cortisol); vaginal bleeding; pregnancy test after any interruption over 14 days.
Support line
Corcept SPARK 1-855-456-7596 (1-855-4KORLYM), enrollment form fax 1-855-288-0601, specialty pharmacist on call 24/7; Corcept Cares Patient Advocate line 1-855-295-9969.
Give your patient their plan
A one-page handout for starting Korlym, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/korlymBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| No REMS; boxed warning | The February 17, 2012 approval letter states that a REMS is not necessary for Korlym, and the current label describes none. The label carries a boxed warning for termination of pregnancy. | FDA letter |
| Confirm the indication | Hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Not for type 2 diabetes unrelated to endogenous Cushing syndrome. | FDA label |
| Pregnancy test and contraception | Negative pregnancy test before initiation in females of reproductive potential. Counsel on non-hormonal contraception during treatment and for one month after stopping; hormonal contraceptives are not to be used. | FDA label |
| Correct hypokalemia | Hypokalemia should be corrected prior to initiating Korlym (section 5.2). | FDA label |
| Medication reconciliation | Contraindicated with simvastatin, lovastatin and narrow therapeutic range CYP3A substrates (cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), and in patients receiving systemic corticosteroids for lifesaving purposes. Review strong CYP3A inhibitors, CYP3A inducers and QT-prolonging drugs. | FDA label |
| Other contraindications | Pregnancy; history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma; known hypersensitivity to mifepristone or any product component. | FDA label |
| Medication Guide | Section 17 says doctors must review the Korlym Medication Guide with every patient as part of counseling. | FDA label |
| SPARK enrollment form | Korlym is only commercially available through SPARK specialty pharmacy partners. The completed SPARK Patient Enrollment Form serves as the prescription; fax it to 1-855-288-0601. SPARK representatives answer at 1-855-456-7596. | Corcept Cares and SPARK |
| After enrollment | Patients are automatically enrolled in SPARK. A Patient Access Coordinator coordinates shipments and helps with coverage and financial aid options; a specialty pharmacist is on call 24/7 and checks for drug-drug interactions. | Corcept Cares and SPARK |
| Enrollment form details | Three pages (US-KOR-25-0043 5-26): prescriber signs either Dispense as written or Substitution allowed, no stamps; preprinted options include 300mg daily for 30 days (QTY 30) and 300mg for 14 days then 600mg for 16 days (QTY 46), with 600mg refills of 60. New York prescribers submit on an original state prescription blank. | SPARK enrollment form |
| Prior authorization help | The form says most payers require PA and SPARK can prepare it, and submit it if the payer allows. It asks for the insurance card, DST, LNSC or UFC reports, HbA1c or other glucose testing (ideally within 6 months, within a year acceptable), chart notes on diagnosis, hyperglycemia and surgical history, medication lists, and confirmation of a negative pregnancy test where it applies. | SPARK enrollment form |
| Monthly confirmation | The patient pages say the coordinator verifies benefits, calls to schedule the first delivery with a pharmacist handoff, then calls every month. Korlym cannot be shipped unless the delivery is confirmed with the patient each month. | Getting Korlym |
| Patient Advocate | Patients who consent get check-in calls from a Corcept Cares Patient Advocate (1-855-295-9969), who explains how Korlym works and what to expect but cannot offer medical advice. | Korlym one-on-one support |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval approved for 12 months. Renewal, also for 12 months, asks for age, the diagnosis, type 2 diabetes or glucose intolerance, and no severe liver impairment. Policy 5.30.025 was last reviewed on June 11, 2026 and took effect July 1, 2026. It cites the September 2024 Korlym package insert, which is the current one. Other plans set their own criteria and their own approval lengths. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 years of age and older | Date of birth on the request | FEP policy |
| Diagnosis | Endogenous Cushing syndrome | Chart note and the biochemical workup | FEP policy |
| Glycemic status | Type 2 diabetes mellitus or glucose intolerance | Diagnosis in the chart, with glucose or HbA1c results | FEP policy |
| Surgical status | Patient has failed surgery, or patient is not a candidate for surgery (initial request only) | Operative or consult note | FEP policy |
| Pregnancy | Females of childbearing potential only: prescriber agrees that pregnancy will be excluded before the initiation of treatment (initial request only) | Attestation on the request; the label requires the negative test | FEP policy |
| Hepatic function | No severe hepatic impairment (Child-Pugh Class C), at initial request and renewal | Chart note or liver panel | FEP policy |
| Approval length | 12 months; renewal limits are the same. No pre-PA allowance. All other indications are considered investigational | Renewal request before month 12 | FEP policy |
Korlym dosing and titration
| When | Label | Source |
|---|---|---|
| Start | 300mg orally once daily as a single daily dose, always with a meal. Swallow whole; do not split, crush or chew. | FDA label |
| Titration | Increase in 300mg increments no more frequently than once every 2 to 4 weeks, based on tolerability and the degree of improvement in Cushing syndrome manifestations. | FDA label |
| Maximum | 1200mg once daily, not to exceed 20mg/kg per day. | FDA label |
| Early response, within 6 weeks | Changes in glucose control, anti-diabetic medication requirements, insulin levels and psychiatric symptoms may help guide early titration. | FDA label |
| Beyond 2 months | Cushingoid appearance, acne, hirsutism, striae and body weight change over a longer period and, with measures of glucose control, may be used to determine dose changes. | FDA label |
| Interruption | Reinitiate at 300mg. If the interruption was for an adverse reaction, aim for a dose lower than the one that resulted in interruption. Repeat the pregnancy test if the interruption exceeded 14 days. | FDA label |
| Renal impairment | No change in the initial dose; maximum 600mg per day. In severe renal impairment mean mifepristone exposure rose 31%, with large variability. | FDA label |
| Hepatic impairment | Mild to moderate: no change in the initial dose; maximum 600mg per day. Severe: should not be used. | FDA label |
| With a strong CYP3A inhibitor already on board | Start at 300mg; if clinically indicated, titrate to a maximum of 900mg. | FDA label |
| Adding a strong CYP3A inhibitor (Table 1) | At 300mg, no change. At 600mg, reduce to 300mg, then titrate to a maximum of 600mg if indicated. At 900mg, reduce to 600mg, then titrate to a maximum of 900mg if indicated. At 1200mg, reduce to 900mg. | FDA label |
| Supply, Korlym | 300mg tablets in bottles of 28 (NDC 76346-073-01) and 280 (NDC 76346-073-02). Store at 25 degrees C (77 degrees F), excursions permitted to 15 to 30 degrees C. | FDA label |
| Generic, Teva | The Actavis-labeled mifepristone 300mg tablet (ANDA 211436) carries the same indication and boxed warning; its label lists bottles of 28 (NDC 0591-4390-96) and 280 (NDC 0591-4390-35). | Generic label |
| Unbranded, Corcept | Corcept lists mifepristone 300mg tablets under NDA 202107 in bottles of 280 (NDC 76346-654-03), debossed Corcept and 300 like Korlym. | Corcept mifepristone label |
| NDC directory | FDA's directory lists 3 mifepristone 300mg products: Korlym (76346-073), Corcept mifepristone (76346-654, marketing start May 28, 2024) and Actavis mifepristone (0591-4390, marketing start January 19, 2024). | FDA NDC directory |
Monitoring the Korlym label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Pregnancy test in females of reproductive potential; serum potassium | Exclude pregnancy; correct hypokalemia before initiating | FDA label |
| 1 to 2 weeks after starting or increasing the dose, then periodically | Serum potassium | Hypokalemia in 44% in Study 400, at any time; give IV or oral potassium by severity, and consider a mineralocorticoid antagonist if it persists | FDA label |
| Throughout | Signs and symptoms of adrenal insufficiency: weakness, nausea, increased fatigue, hypotension, hypoglycemia | Serum cortisol is not an accurate assessment. If suspected, discontinue immediately and give glucocorticoids without delay; high doses may be needed. Reported in 2 of 50 subjects (4%). Evaluate for precipitants such as infection or trauma; may resume at a lower dose after resolution | FDA label |
| Throughout, in women | Vaginal bleeding and endometrial thickening | Refer women with vaginal bleeding to a gynecologist. Bleeding in 5 of 35 females (14%); endometrial thickness above normal in 10 of 26 (38%). Caution with hemorrhagic disorders or anticoagulants | FDA label |
| Throughout | QT interval | Prolongs QTc in a dose-related manner; use the lowest effective dose. Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Little or no experience with other QT-prolonging drugs or potassium channel variants causing long QT. The label sets no ECG schedule | FDA label |
| Shortly after initiation | Respiratory distress | Risk of Pneumocystis jiroveci pneumonia; undertake appropriate diagnostic tests and consider treatment | FDA label |
| Any interruption over 14 days | Pregnancy test | Required before restarting in females of reproductive potential | FDA label |
| Underlying heart disease | Heart failure and coronary vascular disease | Korlym does not reduce serum cortisol, which may activate mineralocorticoid receptors in cardiac tissue; use caution | FDA label |
| Laboratory changes | TSH and HDL-C | TSH rose above normal in 8 of 42 subjects (19%), asymptomatic; HDL-C reductions returned to baseline after discontinuation | FDA label |
| Postmarketing | Angioedema | Listed in section 6.2 | FDA label |
Korlym drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Simvastatin, lovastatin | Contraindicated because of the increased risk of myopathy and rhabdomyolysis; Korlym increased simvastatin and simvastatin acid exposure significantly. | FDA label |
| Narrow therapeutic range CYP3A substrates (cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) | Contraindicated. | FDA label |
| Other CYP3A substrates | Use the lowest dose with monitoring; extreme caution, and alternatives when possible, for drugs with high first pass CYP3A metabolism. | FDA label |
| Strong CYP3A inhibitors (ketoconazole, itraconazole, nefazodone, ritonavir, clarithromycin, posaconazole, voriconazole and others) | Use only when necessary; limit Korlym to 900mg per day. Ketoconazole raised mifepristone AUC 1.38-fold. | FDA label |
| CYP3A inducers (rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's wort) | Avoid co-administration; not studied. | FDA label |
| CYP2C8/2C9 substrates (NSAIDs, warfarin, repaglinide) | Use the smallest recommended doses and monitor closely. Fluvastatin AUC rose 3.57-fold. | FDA label |
| CYP2B6 substrates (bupropion, efavirenz) | Use with caution; not studied. | FDA label |
| Digoxin | AUC rose 1.40-fold. Measure plasma digoxin after 1 to 2 weeks of concomitant use and at appropriate intervals thereafter. | FDA label |
| Hormonal contraceptives | Do not use with Korlym; mifepristone interferes with their effectiveness. Use non-hormonal methods. | FDA label |
| Systemic corticosteroids | Contraindicated when lifesaving (for example immunosuppression after organ transplantation); other steroid-treated conditions may be exacerbated. | FDA label |
| After stopping Korlym | Allow at least 2 weeks before initiating or increasing the dose of any interacting concomitant medication, because of the long terminal half-life. | FDA label |
| Grapefruit juice and lactation | The Medication Guide says not to drink grapefruit juice. Mifepristone is present in milk; women may consider pumping and discarding during treatment and for 18 to 21 days after the last dose. | FDA label |
| Label history on CYP3A inhibitors | S-007 (May 16, 2017) added safety labeling on increased mifepristone exposure with CYP3A inhibitors after a February 3, 2017 FDA letter. | FDA letter |
| Itraconazole study | S-008 (November 5, 2019) added Study C1073-38 results with itraconazole to sections 2, 5.6, 7.2 and 12.3, plus PLLR revisions. | FDA letter |
| Label versions | The prescribing information Corcept posts is dated Revised: 09/2024 and lists the same recent major change, section 2.5, 11/2019, as the SPL. | Corcept prescribing information |
| Supplement history | Drugs@FDA lists the original approval (February 17, 2012), labeling supplements S-006 (October 25, 2016), S-007 and S-008, and manufacturing supplements; none later than S-008 appears. | Drugs@FDA record |
| Generic approval | Drugs@FDA lists ANDA 211436 (Teva, mifepristone 300mg tablets) as approved August 3, 2020 with TE code AB. | Drugs@FDA generic record |
Why a first fill stalls, and the fix
- The prescription went to a local pharmacyCorcept says Korlym is only commercially available through its SPARK specialty pharmacy partners. The office completes the SPARK Patient Enrollment Form, which serves as the prescription, and faxes it to 1-855-288-0601. A SPARK representative answers the phone at 1-855-456-7596, also written 1-855-4KORLYM.
- Prior approval pending or deniedThe Federal Employee Program policy asks for age 18 or older and endogenous Cushing syndrome. It also requires type 2 diabetes or glucose intolerance, and failed surgery or no option of surgery. The endocrinologist's office sends the records that show each point.
- The prior authorization is missing recordsCorcept's enrollment form says most payers require prior authorization, and that SPARK can help prepare it. It lists the cortisol test reports that diagnosed Cushing syndrome and an HbA1c or other glucose test. It also lists chart notes on surgery, the medicine list and a negative pregnancy test where it applies.
- The plan wants pregnancy ruled outFor women who can become pregnant, the same policy asks the prescriber to agree that pregnancy will be excluded before treatment starts. The label requires that test anyway, so the office can confirm it on the request.
- A current medicine cannot be combined with KorlymThe label rules out simvastatin, lovastatin and 8 other named medicines, and it limits or avoids several more. Any change to another medicine is a decision for the prescribers involved.
- The monthly shipment did not comeCorcept says Korlym cannot be shipped unless the Patient Access Coordinator confirms the delivery with you each month. The coordinator also asks about medicine and insurance changes on that call. The coordinator's number is 1-855-456-7596, the same one used for the Specialty Pharmacist.
- A copay you cannot pay, or no coverageCorcept lists a Co-Pay Assistance Program and a Patient Assistance Program for qualifying patients. It also lists medication at no cost for eligible patients who are seeking reimbursement approval, have no insurance or were denied coverage. Corcept's pages do not publish the full terms, so the Patient Access Coordinator at 1-855-456-7596 is the one to ask.
SPARK, the Support Program for Access and Reimbursement for Korlym, with Corcept Cares (Corcept Therapeutics)
- A Patient Access Coordinator who reviews insurance benefits, assists with prior authorization, explains affordability options and coordinates delivery to your door
- A Specialty Pharmacist on call 24/7 who reviews your medication list and answers questions about drug interactions and side effects
- A Co-Pay Assistance Program and a Patient Assistance Program for qualifying patients
- Medication at no cost for eligible patients who are seeking reimbursement approval, have no insurance, or have been denied coverage
- Referral to independent organizations that may provide alternate funding, if needed
- A Corcept Cares Patient Advocate, reached at 1-855-295-9969, who calls to check in if you consent to one-on-one support
- Patient Advocates explain how Korlym works and what to expect, review the resources sent with shipments, and offer emotional support, but cannot give medical advice Korlym one-on-one support
- For prescribers, the SPARK Patient Enrollment Form is faxed to 1-855-288-0601 Corcept Cares and SPARK
Questions prescribers' offices ask about Korlym
What is the Korlym titration schedule?
Start 300mg once daily with a meal, then increase in 300mg increments no more frequently than once every 2 to 4 weeks, per the September 2024 label (section 2.2). Maximum 1200mg once daily, not to exceed 20mg/kg per day. After any interruption, reinitiate at 300mg; if the interruption was for an adverse reaction, titrate to a dose lower than the one that caused it.
When is pregnancy testing required with Korlym?
A negative pregnancy test is required before initiation and again if treatment is interrupted for more than 14 days in females of reproductive potential, per the September 2024 label (boxed warning, sections 2.1 and 8.3). Non-hormonal contraception is required during treatment and for one month after stopping, unless the patient has had a surgical sterilization. Hormonal contraceptives are not to be used with Korlym.
How often should potassium be checked on Korlym?
Measure serum potassium 1 to 2 weeks after starting or increasing the dose and periodically thereafter, after correcting hypokalemia before initiation, per the September 2024 label (section 5.2). Hypokalemia was observed in 44% of subjects in Study 400 and can occur at any time. Treat with intravenous or oral potassium by severity, and consider a mineralocorticoid antagonist if it persists.
Why can serum cortisol not be used to monitor Korlym?
Mifepristone has a half-life of 85 hours and blocks the glucocorticoid receptor without reducing cortisol, so serum cortisol stays elevated or rises and does not assess hypoadrenalism, per the September 2024 label (sections 5.1 and 12.2). Monitor for weakness, nausea, increased fatigue, hypotension and hypoglycemia. If adrenal insufficiency is suspected, the label says to discontinue Korlym immediately and give glucocorticoids without delay, possibly at high doses.
What do insurers ask for to approve Korlym?
The FEP policy shown here, 5.30.025, effective July 1, 2026, asks for age 18 or older, endogenous Cushing syndrome, type 2 diabetes mellitus or glucose intolerance, failed surgery or not a surgical candidate, prescriber agreement that pregnancy will be excluded in females of childbearing potential, and no Child-Pugh C hepatic impairment, with approval for 12 months. Renewal drops the surgery and pregnancy items.
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Sources
- KORLYM (mifepristone) 300mg tablets: prescribing information and Medication Guide, revised 09/2024, SPL version 26, Corcept Therapeutics Incorporated, via the openFDA drug label API, 2025-09-25.
- KORLYM (mifepristone) 300 mg Tablets, Highlights of Prescribing Information and Medication Guide, Revised: 09/2024, Corcept Therapeutics Incorporated, 2024-09.
- How to Get Korlym, Getting your medicine, Corcept Therapeutics Incorporated, 2026-11-12.
- One-on-One Support for Korlym, Corcept Therapeutics Incorporated, 2026-11-12.
- Corcept Cares and SPARK - Korlym (mifepristone) HCP, Corcept Therapeutics Incorporated, 2026-11-12.
- 5.30.025 Korlym, Prescription Drugs, Endocrine and Metabolic Drugs, Blue Cross Blue Shield Association, Federal Employee Program, 2026-07-01.
- Patient Enrollment and Prescription Form for Korlym (mifepristone), US-KOR-25-0043 5-26, Corcept Therapeutics Incorporated, 2026-05.
- NDA 202107 approval letter, Korlym (mifepristone) tablets, 300 mg, FDA, 2012-02-17.
- NDA 202107/S-007 supplement approval letter, safety labeling on CYP3A inhibitors, FDA, 2017-05-16.
- NDA 202107/S-008 supplement approval letter, itraconazole interaction study and Pregnancy Lactation Labeling Rule revisions, FDA, 2019-11-05.
- Drugs@FDA record for NDA 202107, Korlym, via openFDA, FDA, 2026-11-12.
- Drugs@FDA record for ANDA 211436, mifepristone 300mg tablets, Teva Pharmaceuticals USA, via openFDA, FDA, 2026-11-12.
- Mifepristone tablets 300mg (Actavis Pharma, Teva): prescribing information and Medication Guide, issued 2/2022, Actavis Pharma, Inc., via the openFDA drug label API, 2022-02-01.
- Mifepristone 300mg tablets (Corcept, under NDA 202107): prescribing information and Medication Guide, revised 09/2024, Corcept Therapeutics Incorporated, via the openFDA drug label API, 2025-09-25.
- NDC directory listings for mifepristone 300mg tablets, via openFDA, FDA, 2026-11-12.
A reference drawn from the September 25, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 12, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.