Your first 90 days
Your first 90 days on Recorlev for Cushing's syndrome
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Recorlev lowers the amount of cortisol the adrenal glands make, and its label pairs it with frequent testing. Liver blood tests, heart tracings and blood salts all come before the first dose and keep coming afterward. The first 3 months also bring urine cortisol collections and slow dose changes. This page lays out those weeks from the FDA label, Xeris's own Recorlev pages and one insurer's written rules.
What has to happen before the first bottle ships
Recorlev has no REMS, so the first fill waits on baseline tests, a full medicine review and an insurance approval. These are the 5 things in the way, in order.
Liver blood tests
The label asks for ALT, AST and total bilirubin before the first dose.
- Recorlev is not used when AST or ALT is above 3 times the upper normal limit.
- The label also rules it out with cirrhosis, active or poorly controlled liver disease, or repeated gallstone attacks.
- Past liver injury from ketoconazole or another azole antifungal also rules it out.FDA label
An ECG, and potassium and magnesium
A baseline ECG measures the heart's QT interval before day 1.
- The label says Recorlev is not used when that interval, read as QTcF, is above 470 msec.
- Low potassium or magnesium is corrected before starting, because both raise the risk of QT prolongation.FDA label
A full medicine review
Recorlev cannot be combined with medicines that prolong the QT interval or with certain drugs broken down by the CYP3A4 liver enzyme.
- The label also says to avoid strong CYP3A4 blockers and boosters from 2 weeks before the first dose.
- The endocrinologist and pharmacist go through every prescription and nonprescription product you take.FDA label
The Start Form and insurance approval
The endocrinologist's office faxes a Start Form to Xeris CareConnection, with insurance cards, chart notes and a medicine list from the last 6 months.
- A company called CloudTop can prepare and submit the prior authorization for the office.
- The form also asks whether the baseline liver tests and ECG are done.Recorlev Start Form
A call from PANTHERx Rare Pharmacy
Xeris says PANTHERx Rare Pharmacy is the only pharmacy that carries Recorlev, and it delivers to your home.
- A PANTHERx case manager confirms your insurance and shipping address.
- Xeris's guide asks you to answer calls from PANTHERx so the shipment can be scheduled.Getting started guide
The days that matter
Counted from the first dose, with the liver test schedule, the urine cortisol checks, the earliest dose changes and the monthly refill. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Medicine review
The label says strong CYP3A4 blockers and boosters are avoided from 2 weeks before the first dose.
- Examples it names include ritonavir, mifepristone, rifampicin, carbamazepine, phenytoin and mitotane.
Liver tests, ECG, potassium and magnesium
ALT, AST and total bilirubin, a baseline ECG, and correction of any low potassium or magnesium.
- The label does not set an exact number of days ahead.
Insurance approval, then PANTHERx calls
The plan reviews the prior authorization, which CloudTop can submit for the office.
- PANTHERx Rare Pharmacy then contacts you to arrange delivery of the first bottle.
First dose, 150mg twice a day
One 150mg tablet by mouth twice a day, with or without food, is the label's starting dose.
- The endocrinologist sets any later changes from your test results.
Weekly liver tests, for at least 6 weeks
The label asks for liver enzymes and bilirubin weekly for at least the first 6 weeks.
- Weekly testing also restarts after any pause or dose increase until the dose is stable.
Weekly liver tests, number 2
Urine cortisol and the earliest dose change
At least two 24-hour urine cortisol collections are checked every 2 to 3 weeks until the response is adequate.
- The dose can rise by 150mg a day, no sooner than every 2 to 3 weeks, with an ECG before each increase.
Weekly liver tests, number 3
Weekly liver tests, number 4
Refill shipment, about monthly
Xeris's Start Form writes Recorlev as a 30-day supply with up to 11 refills.
- The endocrinologist can write titration instructions on the same form when the dose changes.
Weekly liver tests, number 5
Weekly liver tests, number 6
Weekly liver tests, number 7
Weekly liver tests, number 8
Liver tests every 2 weeks
After the first 6 weeks, the label moves liver tests to every 2 weeks for the next 6 weeks.
- Monthly tests follow for 3 more months, then as the endocrinologist decides.
Refill shipment, number 2
Weekly liver tests, number 9
Weekly liver tests, number 10
Liver tests every 2 weeks, number 2
Weekly liver tests, number 11
Weekly liver tests, number 12
Liver tests every 2 weeks, number 3
Refill shipment, number 3
Three months in
In the trials, among people with normal liver tests at the start, enzymes above 3 times normal appeared at a median of day 83.
- Low cortisol first appeared at a median of day 96, so symptoms still matter here.
Weekly liver tests, number 13
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Recorlev label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated March 10, 2026, read from the FDA's label database today. FDA label
- August 2023
The FDA approved a label update after a May 2023 safety letter about lurasidone, an antipsychotic. Lurasidone joined the list of drugs that are contraindicated or not recommended with Recorlev. The distributor address on the label was also updated at that time.FDA letter
- December 2021
Recorlev was first approved for high cortisol in adults with Cushing's syndrome when surgery is not an option or was not curative. The FDA asked the company to report all liver injury cases quickly for 5 years.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Twice a day, with or without food
The label gives Recorlev by mouth twice a day, and food is optional.
- The tablets are pink and round, with LEV above 150 printed in black ink.FDA label
- If you miss a dose
The Medication Guide says that after a missed dose, you take the next dose at your regular scheduled time.
- If you take too much, call your doctor or go to the nearest emergency room right away.FDA label
- How the dose changes
The label raises the dose by 150mg a day at a time, based on urine cortisol results and how you feel.
- The highest recommended dose is 600mg twice a day, and side effects can bring it down to 150mg once a day.
- Every one of these changes is the endocrinologist's decision, not the patient's.FDA label
- Medicines that cannot be combined
The label rules out medicines that prolong the QT interval, and rules out or advises against certain drugs broken down by CYP3A4.
- Examples it lists include simvastatin, lovastatin, midazolam, triazolam, methadone, quinidine and clarithromycin.
- Atorvastatin above 20mg a day and metformin need closer watching, and the prescriber may adjust them.FDA label
- Antacids and acid reducers
The label says some stomach medicines reduce how well Recorlev is absorbed.
- It says antacids such as aluminum hydroxide are taken at least 2 hours after a Recorlev dose.
- It also says to avoid acid reducers such as H2 blockers and proton pump inhibitors, and sucralfate.FDA label
- Alcohol
The label advises against heavy drinking while taking Recorlev, because of the liver risk.
- With ketoconazole, alcohol has caused flushing, rash, swelling, nausea and headache that cleared within a few hours.FDA label
- The first few weeks
Xeris's patient guide says lower cortisol can bring flu-like symptoms in the first few weeks, such as fatigue, nausea, headache and muscle aches.
- It says these may be a sign Recorlev is working or of something more serious, so tell your doctor about them.Getting started guide
- Not for fungal infections
Recorlev is related to the antifungal ketoconazole, but the label says it is not approved for fungal infections.
- Its safety and effectiveness for that use have not been established.FDA label
- Pregnancy, breastfeeding and fertility
The label says Recorlev may harm an unborn baby, so tell the doctor right away about a pregnancy.
- It advises no breastfeeding during treatment and for 1 day after the last dose.
- It may lower testosterone and affect fertility in women and men.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius), with short swings between 59 and 86 degrees allowed.
- Each bottle holds 50 tablets and has a child-resistant cap.FDA label
- Side effect reports
The label lists Xeris Pharmaceuticals at 1-877-937-4737 for reporting side effects.
- Reports can also go straight to the FDA at 1-800-FDA-1088.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of liver injury
Pain on the upper right side of the belly with nausea, unusual tiredness, yellow skin or eyes, or unusual bruising or bleeding.
- The Medication Guide says to call the doctor right away.
- In the trials, 13% of people had a peak ALT or AST above 3 times normal.FDA label
Severe lightheadedness or fainting
These can be signs of QT prolongation, an irregular heartbeat that can be life threatening.
- The Medication Guide says to call the doctor right away.
- In the trials, 2.4% of people had a QTcF above 500 msec.FDA label
Signs of low cortisol
Nausea, vomiting, dizziness, unusual tiredness, low blood pressure, unexplained belly pain, loss of appetite, low blood sugar or body aches.
- The Medication Guide says to call the doctor right away.
- Low cortisol affected 7% of people across the 2 main trials.FDA label
An allergic reaction
Rash, itching, hives, fever, swelling of the lips or tongue, chest pain or trouble breathing.
- The Medication Guide says to call the doctor right away or go to an emergency center.FDA label
Signs of low testosterone
For men, breast enlargement or erection problems, and for women, lower sex drive or mood changes.
- The Medication Guide says to call the doctor about these.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Cigna policy
- 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.Recorlev Start Form
- 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.FDA label
- 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.Recorlev Start Form
- 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.Xeris CareConnection
- 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.Recorlev HCP forms
Cigna prior authorization policy, May 1, 2026
- Age 18 or older, with hypercortisolemia
- Per the prescriber, not a candidate for surgery or surgery was not curative, or awaiting surgery, or awaiting the effect of radiotherapy
- Ketoconazole tablets tried first
- Prescribed by or in consultation with an endocrinologist or a physician who specializes in endogenous Cushing's syndrome
- Not covered for fungal infections
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. Xeris CareConnection
Five questions for the pharmacist or the support line
- I take these medicines and supplements. Do any of them prolong the QT interval or interact through CYP3A4?
- I use an antacid or an acid reducer. How should I time it, or is there another option to ask my doctor about?
- How many tablets come in each shipment at my dose, and when will PANTHERx call about the next one?
- If my dose goes up, does PANTHERx need a new prescription before the next shipment?
- Who do I call after hours if I feel faint or notice signs of liver trouble?
Questions people ask in the first weeks
How often are liver tests needed on Recorlev?
The label asks for liver tests before the first dose, then weekly for at least 6 weeks. They continue every 2 weeks for the next 6 weeks and monthly for 3 months, then as the doctor decides. Weekly tests restart after any pause in treatment or any dose increase.
Why does Recorlev need ECGs?
Recorlev can lengthen the QT interval, which can lead to a dangerous heart rhythm. The label asks for an ECG before the first dose and before each dose increase, then routine checks. It also asks for potassium and magnesium to be corrected and checked periodically.
What is the starting dose of Recorlev?
The label starts at 150mg twice a day, with or without food. The dose can rise by 150mg a day, no sooner than every 2 to 3 weeks, up to 600mg twice a day. Urine cortisol results and side effects guide each change the endocrinologist makes.
Does Recorlev have a REMS?
No, the FDA approval letters and the label set no REMS. Recorlev does carry a boxed warning for liver injury and QT prolongation, which is why testing is so frequent.
Can I take an antacid or heartburn medicine with Recorlev?
The label says antacids such as aluminum hydroxide are taken at least 2 hours after a Recorlev dose. It says to avoid H2 blockers, proton pump inhibitors and sucralfate, because they reduce absorption. The endocrinologist decides how to handle any of these medicines.
What if I miss a dose of Recorlev?
The Medication Guide says to take the next dose at your regular time. It does not say to make up the missed dose.
Where do I get Recorlev?
Xeris says PANTHERx Rare Pharmacy is the only pharmacy that carries Recorlev, and it ships to your home. The office sends a Start Form to Xeris CareConnection, and PANTHERx calls you to schedule delivery.
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Sources
- RECORLEV- levoketoconazole tablet: prescribing information, revised 6/2023, and Medication Guide, issued 06/2023, Xeris Pharmaceuticals, Inc., via DailyMed, March 10, 2026.
- RECORLEV (levoketoconazole) tablets, prescribing information, revised 06/2023, FDA, Drugs@FDA, August 16, 2023.
- Xeris CareConnection, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., November 10, 2026.
- Meet your support team, Recorlev (levoketoconazole), Xeris Pharmaceuticals, Inc., November 10, 2026.
- Dosing & Monitoring, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., November 10, 2026.
- Tool and Resources, RECORLEV (levoketoconazole), Xeris Pharmaceuticals, Inc., November 10, 2026.
- RECORLEV Getting Started Forms (Start Form, Patient Authorization and CloudTop Prior Authorization Request), Xeris Pharmaceuticals, Inc., November 10, 2026.
- Getting started with RECORLEV (levoketoconazole): Treatment tips and support guide, Xeris Pharmaceuticals, Inc., November 10, 2026.
- 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, January 31, 2022.
- Drug Coverage Policy IP0389, Cushing's, Recorlev (levoketoconazole tablets, Xeris), Cigna, May 1, 2026.
- NDA 214133/S-003 supplement approval letter, lurasidone interaction and distributor address, FDA, August 16, 2023.
- NDA 214133 approval letter, Recorlev (levoketoconazole) tablets, FDA, December 30, 2021.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing endocrinologist. Found an error? Use the report link in the footer and it will be checked against the source.