Prescribing guide
Recorlev (levoketoconazole)Liver and QT monitoring, titration, CYP3A4 interactions and prior authorization criteria for Cushing's syndromeFor prescribers and their offices treating Cushing's syndrome (high cortisol): 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; baseline ALT, AST and total bilirubin, baseline ECG with QTcF 470 msec or less, correction of hypokalemia and hypomagnesemia, a CYP3A4 and QT medication review, prior authorization and dispensing only through PANTHERx Rare Pharmacy.
Example PA threshold
Cigna example: age 18 or older, hypercortisolemia, surgery not an option or not curative (or awaiting surgery or radiotherapy effect), ketoconazole tablets tried, endocrinologist or Cushing's specialist.
Monitoring
LFTs weekly for at least 6 weeks, every 2 weeks for 6 weeks, monthly for 3 months; ECG before each dose increase; K and Mg periodically; 24-hour UFC every 2 to 3 weeks during titration, then every 1 to 2 months.
Support line
Xeris CareConnection and PANTHERx Rare Pharmacy 1-844-444-RCLV (7258), Start Form fax 1-312-276-4846, CloudTop PA fax 1-872-201-1062; $0 co-pay program for eligible commercial patients.
Give your patient their plan
A one-page handout for starting Recorlev, 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/recorlevBefore 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 | Neither the label nor the FDA approval letters set a REMS. The label carries a boxed warning for hepatotoxicity and QT prolongation. | FDA label |
| Baseline liver tests | ALT, AST and total bilirubin before initiation (section 2.1). Contraindicated with baseline AST or ALT above 3 times ULN, cirrhosis, acute or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, prior azole DILI requiring discontinuation, or extensive metastatic liver disease. | FDA label |
| Baseline ECG and electrolytes | Obtain a baseline ECG and correct hypokalemia and hypomagnesemia before starting. Contraindicated with QTcF above 470 msec, history of torsades de pointes, VT, VF or long QT syndrome including first-degree family history. | FDA label |
| Medication reconciliation | Contraindicated with QT-prolonging drugs associated with ventricular arrhythmias and with certain sensitive CYP3A4 or CYP3A4 and P-gp substrates. Avoid strong CYP3A4 inhibitors and inducers from 2 weeks before and during treatment. | FDA label |
| Start Form | Fax the Start Form with both sides of insurance and pharmacy cards, a 6-month medication list, chart notes and recent diagnostic results to Xeris CareConnection at 1-312-276-4846. The patient authorization page is not required at submission. The form asks whether baseline LFTs and ECG have been performed. | Recorlev Start Form |
| Prior authorization through CloudTop | By signing the Start Form, the prescriber authorizes CloudTop Health to prepare and submit PA and appeal requests. Send the PA packet by fax to 1-872-201-1062, email xeris@cloudtophealth.com or the CloudTop portal. | Recorlev Start Form |
| Clinical pharmacist line | Xeris's dosing page says a clinical pharmacist is available to support monitoring and dose modifications at 1-844-444-RCLV (7258). | Recorlev HCP dosing |
| Label version | The FDA-approved S-003 label PDF reads Revised 06/2023, and DailyMed's version updated March 10, 2026 carries the same revision date. | FDA label PDF |
| Pharmacy | PANTHERx Rare Pharmacy is the only pharmacy that carries Recorlev; it delivers to patients, works with the office on coverage and helps manage drug-drug interactions. | Xeris CareConnection |
Prior authorization criteria and what to document
One public policy as the example: Cigna, May 1, 2026. Approval approved for 1 year at a time. Policy IP0389 took effect May 1, 2026, after a review on April 9, 2026 with no criteria changes. It cites the June 2023 Recorlev label, the same text DailyMed carries now. 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 or older | Date of birth on the request | Cigna policy |
| Diagnosis | Hypercortisolemia in endogenous Cushing's syndrome | Cortisol testing that documents hypercortisolemia | Cigna policy |
| Surgical status | Per the prescriber, not a surgical candidate or surgery not curative; or awaiting surgery; or awaiting therapeutic response after radiotherapy | Chart notes with operative history or the reason surgery is not an option | Cigna policy |
| Step therapy | Patient has tried ketoconazole tablets | Fill history or chart note on the ketoconazole trial and outcome | Cigna policy |
| Prescriber | Prescribed by or in consultation with an endocrinologist or a physician who specializes in endogenous Cushing's syndrome | Specialty on the request, or the consult note | Cigna policy |
| CloudTop packet | CloudTop's request list: liver function (ALT, AST, total bilirubin), plasma ACTH, dexamethasone suppression test, chart notes, prior Cushing's treatments, ECG, 24-hour UFC and total cortisol | Lab reports, ECG and notes sent with the PA request | Recorlev Start Form |
| Approval | Approved for 1 year; not covered for fungal infections; samples do not satisfy criteria | Renewal criteria are not separately listed in IP0389 | Cigna policy |
Recorlev dosing and titration
| When | Label | Source |
|---|---|---|
| Start | 150mg orally twice daily, with or without food. | FDA label |
| Titration | Increase by 150mg a day no more frequently than every 2 to 3 weeks, based on 24-hour UFC and tolerability. ECG before each increase; weekly LFTs after each increase until stable. | FDA label |
| Maximum and minimum | Maximum 1200mg a day as 600mg twice daily. May reduce to 150mg once daily for tolerability. | FDA label |
| Inadequate response | If UFC stays above ULN at 1200mg a day, or the patient cannot tolerate treatment, consider discontinuing and switching therapy. | FDA label |
| Missed dose | Take the next dose at the regularly scheduled time. | FDA label |
| Supply | 150mg pink film-coated tablets in bottles of 50 (NDC 72065-003-01), which is 25 days at the starting dose. | FDA label |
| Start Form prescription | Preprinted as 1 tablet twice daily, 30-day supply, up to 11 refills, with a field for titration or other dosing instructions. | Recorlev Start Form |
| Food | A high-fat meal raised AUC by 30% after a single 600mg dose in healthy volunteers; the label allows dosing with or without food. | FDA label |
Monitoring the Recorlev label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | ALT, AST, total bilirubin; ECG; potassium and magnesium | Correct hypokalemia and hypomagnesemia before starting | FDA label |
| LFT schedule | Weekly for at least 6 weeks, every 2 weeks for the next 6 weeks, monthly for the next 3 months, then as clinically indicated | Weekly again after any interruption or dose increase until stable | FDA label |
| ALT or AST 5 times ULN or more, or 3 times ULN or more with bilirubin above 2 times ULN | Hepatotoxicity | Permanently discontinue | FDA label |
| ALT or AST 3 to under 5 times ULN, bilirubin 2 times ULN or less | Hepatotoxicity | Interrupt; LFTs every 3 days until stable, then every 7 to 10 days to baseline; may restart lower and titrate slower; weekly LFTs for 1 month before any increase; discontinue if it recurs | FDA label |
| ALT or AST above ULN to under 3 times ULN, rising above baseline | Liver tests | LFTs every 7 to 10 days until back to baseline; consider interruption | FDA label |
| QTcF above 500 msec | ECG | Interrupt; correct contributors such as hypokalemia, hypomagnesemia or concomitant drugs; may resume at a lower dose when 500 msec or less; discontinue if it recurs | FDA label |
| Cortisol | At least two 24-hour UFC every 2 to 3 weeks during titration, then at least every 1 to 2 months; morning serum or plasma cortisol and hypocortisolism symptoms periodically | Reduce or interrupt for low or rapidly falling cortisol; stop and give glucocorticoid replacement if low with symptoms; suppression may outlast the 4 to 6 hour half-life | FDA label |
| Trial timing | AST or ALT above 3 times ULN in 11% of patients normal at baseline, median day 83; hypocortisolism in 7%, median day 96 (range 26 to 166) | QTcF above 500 msec in 2.4% and an increase above 60 msec in 14.7% | FDA label |
Recorlev drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| QT-prolonging CYP3A4 or P-gp substrates | Contraindicated. Examples include bosutinib, cisapride, clarithromycin, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat (in some CYP2D6 metabolizers), ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine and ranolazine. | FDA label |
| Sensitive CYP3A4 or CYP3A4 and P-gp substrates | Contraindicated or not recommended. Examples include alfentanil, avanafil, buspirone, conivaptan, dabigatran etexilate, darifenacin, darunavir, digoxin, everolimus, ibrutinib, lomitapide, lovastatin, lurasidone, midazolam, simvastatin, sirolimus, tacrolimus, triazolam and vardenafil. | FDA label |
| Atorvastatin | May need a lower atorvastatin dose; use the lowest possible and monitor for myopathy above 20mg a day. | FDA label |
| Metformin and other OCT2 or MATE substrates | During titration, monitor glycemia, kidney function and vitamin B12 and adjust metformin as needed. | FDA label |
| Strong CYP3A4 inhibitors and inducers | Not recommended; avoid from 2 weeks before and during treatment. Examples include ritonavir, boosted darunavir or fosamprenavir, saquinavir, mifepristone, isoniazid, rifabutin, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine and mitotane. | FDA label |
| Gastric acid modifiers | Give antacids such as aluminum hydroxide at least 2 hours after Recorlev; avoid H2 blockers, PPIs and sucralfate. | FDA label |
| Hepatotoxic drugs and alcohol | Avoid hepatotoxic drugs; advise against excessive alcohol. Disulfiram-like reactions have been reported with ketoconazole. | FDA label |
| Label history | Lurasidone was added in August 2023 after the FDA's May 3, 2023 safety labeling letter under section 505(o)(4). | FDA letter |
Why a first fill stalls, and the fix
- The plan wants ketoconazole tried firstCigna's policy approves Recorlev only after the patient has tried ketoconazole tablets. This is a plan rule, not a judgment about the diagnosis. The endocrinologist's office decides whether to document a ketoconazole trial or ask for an exception.
- Prior authorization pending or missing recordsCloudTop's request list for Recorlev includes liver tests, an ECG, 24-hour urine cortisol, total cortisol, plasma ACTH and a dexamethasone suppression test. It also asks for chart notes and past Cushing's treatments. The office can send these by fax, email or CloudTop's online portal.
- A current medicine cannot be combined with RecorlevThe label rules out QT-prolonging medicines and certain CYP3A4 drugs, and it avoids strong CYP3A4 blockers and boosters. Any change to another medicine is a decision for the prescribers involved.
- The prescription went to a local pharmacyThe office faxes Xeris's Start Form to Xeris CareConnection, and the form authorizes forwarding it to PANTHERx Rare Pharmacy. PANTHERx then contacts the patient directly to arrange home delivery.
- A copay you cannot payXeris offers a $0 co-pay program for eligible commercially insured patients, and its pages say restrictions apply. They also mention access support for patients with and without insurance. The full terms are not published on the pages we read, so ask the support line at 1-844-444-7258.
- The plan denied RecorlevXeris posts sample letters of medical necessity, appeal letters and formulary exception letters for offices. The endocrinologist's office decides whether to appeal and what to send.
Xeris CareConnection (Xeris Pharmaceuticals) with PANTHERx Rare Pharmacy
- A $0 co-pay program for eligible commercially insured patients, with eligibility requirements, restrictions and limitations
- Access and support for patients with and without insurance
- Free specialty pharmacy services from PANTHERx Rare Pharmacy, including 24/7 support and home delivery
- Clinical pharmacists who specialize in endocrinology products and check in regularly
- A dedicated Patient Access Manager, reachable by call, text or email, who can connect you with Cushing's advocacy groups Meet your support team
- Prior authorization and appeal paperwork prepared by CloudTop for the prescriber's office Recorlev Start Form
- A Patient Assistance Program for eligible patients with financial hardship or limited or no insurance, as announced at launch in January 2022 Xeris launch release
Questions prescribers' offices ask about Recorlev
What liver monitoring does the Recorlev label require?
ALT, AST and total bilirubin at baseline, then weekly for at least 6 weeks, every 2 weeks for the next 6 weeks, monthly for the next 3 months and then as clinically indicated, per the label revised June 2023 (sections 2.1 and 2.3). Monitor weekly again after any interruption or dose increase until the dosage is stable. Baseline AST or ALT above 3 times ULN is a contraindication; above ULN up to 3 times ULN calls for careful benefit-risk review.
What ECG and electrolyte monitoring does Recorlev need?
A baseline ECG, an ECG before each dose increase and routine QT monitoring once the dosage is stable, per the June 2023 label (sections 2.1, 2.3 and 5.2). Correct hypokalemia and hypomagnesemia before starting and monitor potassium and magnesium periodically. Baseline QTcF above 470 msec is a contraindication; interrupt if QTcF exceeds 500 msec.
What is the Recorlev titration schedule?
Start at 150mg twice daily with or without food and titrate by 150mg a day no more often than every 2 to 3 weeks, to a maximum of 600mg twice daily (1200mg a day), per the June 2023 label (section 2.2). Titration is guided by at least two 24-hour UFC collections every 2 to 3 weeks; the dose may be reduced to 150mg once daily for tolerability.
Does Recorlev have a REMS?
No. The December 30, 2021 approval letter and the August 16, 2023 supplement letter set no REMS, and the June 2023 label has none, though it carries a boxed warning for hepatotoxicity and QT prolongation. The approval letter did record an agreement to report all hepatotoxicity cases as 15-day alerts for 5 years.
What do insurers ask for to approve Recorlev?
The Cigna policy IP0389 shown here, effective May 1, 2026, asks for age 18 or older, hypercortisolemia, non-curative surgery or not a surgical candidate (or awaiting surgery or radiotherapy response), a trial of ketoconazole tablets and an endocrinologist or Cushing's specialist, with approval for 1 year. It cites the June 2023 label, the current text.
Free email alert
Get an email when the Recorlev label changes
One email the day the FDA revises the Recorlev prescribing information, with a summary of what changed. No trial alerts or newsletter, and you can stop anytime.
Label changes for Recorlev only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Sources
- RECORLEV- levoketoconazole tablet: prescribing information, revised 6/2023, and Medication Guide, issued 06/2023, Xeris Pharmaceuticals, Inc., via DailyMed, 2026-03-10.
- RECORLEV (levoketoconazole) tablets, prescribing information, revised 06/2023, FDA, Drugs@FDA, 2023-08-16.
- Xeris CareConnection, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., 2026-11-10.
- Meet your support team, Recorlev (levoketoconazole), Xeris Pharmaceuticals, Inc., 2026-11-10.
- Dosing & Monitoring, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., 2026-11-10.
- Tool and Resources, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., 2026-11-10.
- RECORLEV Getting Started Forms (Start Form, Patient Authorization and CloudTop Prior Authorization Request), Xeris Pharmaceuticals, Inc., 2026-11-10.
- Getting started with RECORLEV (levoketoconazole): Treatment tips and support guide, Xeris Pharmaceuticals, Inc., 2026-11-10.
- Xeris Biopharma Announces Recorlev (levoketoconazole) Is Now Commercially Available for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing's Syndrome, Xeris Biopharma Holdings, Inc., via Business Wire, 2022-01-31.
- Drug Coverage Policy IP0389, Cushing's, Recorlev (levoketoconazole tablets, Xeris), Cigna, 2026-05-01.
- NDA 214133/S-003 supplement approval letter, lurasidone interaction and distributor address, FDA, 2023-08-16.
- NDA 214133 approval letter, Recorlev (levoketoconazole) tablets, FDA, 2021-12-30.
A reference drawn from the March 10, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 10, 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.