Your first 90 days
Your first 90 days on Isturisa for Cushing 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.
Isturisa has no safety program forms and no vaccine standing between the prescription and the first fill. What it does have is a heart tracing and a blood check before day 1. After that come close cortisol testing and slow dose steps over the first weeks. Low cortisol was most common in the first 12 weeks of the main trial, which is the stretch this page covers. It lays out those weeks from the FDA label, Recordati Rare Diseases' own Isturisa pages and one insurer's written rules.
What has to happen before the first bottle ships
Isturisa has no REMS, and the first fill waits on an ECG, a potassium and magnesium check, an insurance approval and a pharmacy call. These are the 6 things in the way, in order.
A heart tracing, called an ECG
Isturisa can lengthen a part of the heartbeat called the QT interval, and the label says this rises with the dose.
- The label asks for an ECG before the first dose as a starting point.
- The Patient Information says another ECG comes 1 week after starting.FDA label
Potassium and magnesium
The label asks for low potassium and low magnesium to be corrected before Isturisa starts.
- Low levels add to the heart rhythm risk, and Isturisa itself can lower potassium.
- The label also asks for potassium and magnesium to be checked from time to time during treatment.FDA label
A medicine list, with heart medicines in mind
The Patient Information asks people to tell the doctor about every medicine, especially ones for heart problems.
- The label halves the Isturisa dose with strong CYP3A4 blockers such as itraconazole or clarithromycin.
- Medicines such as carbamazepine, rifampin and phenobarbital can lower Isturisa levels.FDA label
The prescription goes to one pharmacy
Recordati's prescriber site says all Isturisa prescriptions are filled through its specialty pharmacy, Anovo.
- The endocrinologist's office faxes a Patient Prescription Form or sends it electronically.
- Patients can also complete an enrollment opt-in form for the R.A.R.E. Patient Support Program.Isturisa HCP support
The insurance approval
Plans such as Cigna require prior authorization before they pay for Isturisa.
- Cigna asks for a documented diagnosis, an endocrinologist and a reason surgery is not the answer.
- Some Cigna plans also want another cortisol medicine tried first.Cigna policy
Help paying, from Recordati
Recordati Rare Diseases offers a $20 co-pay for qualified patients with commercial insurance.
- Its R.A.R.E. team also helps with prior authorization, appeals and finding other financial help.
- The R.A.R.E. phone number is 1-888-855-7273, which Recordati also writes as 1-888-855-RARE.Isturisa patient support
The days that matter
Counted from the first dose, with the week 1 ECG, the urine cortisol tests, the 2-week dose steps 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.ECG and potassium and magnesium check
A baseline heart tracing, plus blood tests that let low potassium or magnesium be corrected first.
- The label does not set an exact number of days ahead.
Prescription form to Anovo
The office faxes the Patient Prescription Form to Anovo or sends it through its electronic records system.
- R.A.R.E. then checks insurance benefits and sends the office any prior authorization form.
The pharmacist calls
Once benefits are set, Recordati's guide says a pharmacist calls the patient to arrange overnight delivery.
- Answer calls from numbers you do not know that week.
First dose, 2mg twice a day
Two 1mg tablets in the morning and two in the evening is one way to make the starting dose.
- The label says Isturisa can be taken with or without food.
Second ECG
The label asks for a repeat ECG within 1 week of starting, and again whenever the doctor thinks it is needed.
24-hour urine cortisol tests
The label asks for at least two 24-hour urine collections every 1 to 2 weeks until the response holds steady.
- Each collection means saving all urine for a full day.
Earliest dose change
The label lets the dose rise by 1mg to 2mg twice a day, no more often than every 2 weeks.
- The endocrinologist decides from cortisol results, side effects and symptoms.
24-hour urine cortisol tests, number 2
Refill, if the first fill was a month
Each carton holds 60 tablets, which is 15 days at the starting dose using 1mg tablets.
- How long a fill lasts depends on the prescribed dose and supply, so ask Anovo when to expect the next shipment.
24-hour urine cortisol tests, number 3
24-hour urine cortisol tests, number 4
Refill, number 2
24-hour urine cortisol tests, number 5
24-hour urine cortisol tests, number 6
Refill, number 3
Three months in
In the main trial, low cortisol was reported in 31% of people in the first 12 weeks and 18% in weeks 12 to 26.
- Once the dose is steady, the label asks for cortisol checks at least every 1 to 2 months.
24-hour urine cortisol tests, number 7
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Isturisa 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 November 18, 2025, read from the FDA's label database today. FDA label
- November 2025
The carton changed to 6 blister packs of 10 tablets, still 60 tablets in all. The FDA approved removing a wallet and sleeve that held the older blister cards of 20.FDA letter
- July 2025
Results of a second trial, with a 12-week placebo period, were added. The label also added reports of low white cells with fever and infection. The Patient Information now says to report any one low cortisol symptom, not more than one.FDA letter
- April 2025
The FDA broadened the use from Cushing disease to endogenous Cushing syndrome when surgery is not an option or has not been curative. This label version lists only the 1mg and 5mg tablets, without the 10mg.FDA letter
- March 2020
Isturisa was first approved for adults with Cushing disease when pituitary surgery was not an option or not curative. The first approval letter covered 1mg, 5mg and 10mg tablets.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 starts Isturisa at 2mg twice a day and says food does not matter.
- The Patient Information says the doctor decides how many tablets to take and when the dose changes.FDA label
- If you miss a dose
The label says to skip the missed dose and take the next one at the usual time.
- The label does not say to take an extra dose to make up for it.FDA label
- Two tablet strengths
Isturisa comes in 2 strengths, a 1mg tablet and a 5mg tablet.
- Recordati says the doctor may combine the two strengths to make each dose.Starting Isturisa
- How the dose climbs
The label raises the dose by 1mg to 2mg twice a day, no more often than every 2 weeks.
- Doses above 10mg twice a day can rise by 5mg twice a day every 2 weeks.
- The highest dose the label allows is 30mg twice a day.FDA label
- Where doses settled in the trials
The label says the steady doses in the trials varied between 2mg and 7mg twice a day.
- Every 2 weeks is the fastest pace the label allows for raising the dose, not a fixed schedule.FDA label
- Low cortisol can outlast the tablet
Isturisa has a half-life of about 4 hours, the time it takes for half of it to leave the body.
- The label warns that low cortisol may last longer than that after a pause or a stop.FDA label
- Medicines that change the dose
Strong CYP3A4 blockers such as itraconazole and clarithromycin call for half the Isturisa dose.
- Strong inducers such as carbamazepine, rifampin and phenobarbital may need a higher dose, and stopping one may need a lower dose.
- The pharmacist needs to hear about every new medicine, even a short course.FDA label
- Liver and kidney conditions
The label starts at 1mg twice a day with moderate liver disease and 1mg each evening with severe liver disease.
- Kidney disease needs no dose change, but urine cortisol results read lower with moderate or severe kidney disease.FDA label
- Pregnancy and breastfeeding
There are no data on Isturisa in pregnancy, and the label notes that active Cushing syndrome carries its own pregnancy risks.
- The label says not to breastfeed during treatment and for 1 week after the last dose.FDA label
- Birth control pills
In a label study, 12 days of Isturisa at 30mg twice a day did not significantly change levels of an estradiol and levonorgestrel pill.FDA label
- Storage
Room temperature, between 68 and 77 degrees Fahrenheit, with short swings between 59 and 86 degrees allowed.
- The label asks for the tablets to be kept dry.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 low cortisol
Nausea, vomiting, tiredness, low blood pressure, belly pain, loss of appetite, dizziness or low blood sugar.
- The Patient Information says to tell the doctor right away.
- The label says low cortisol can happen at any time and can be life-threatening.FDA label
An irregular heartbeat
The Patient Information says to call the doctor right away about irregular heartbeats.
- In the main trial, 13% of people had a new QT reading above 450 milliseconds on an ECG.FDA label
Low potassium, high blood pressure or swelling
Isturisa can raise other adrenal hormones, which can lower potassium and raise blood pressure.
- In the main trial, low potassium affected 17% and high blood pressure 14%.
- The Patient Information says to call the doctor about these or about swelling in the legs or ankles.FDA label
Extra hair growth or acne in women
Isturisa can raise testosterone levels in women, which can show up on the skin.
- The label reports mild to moderate extra hair growth at 12% and acne at 11% in some women in the main trial.
- The Patient Information says to call the doctor about either one.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 another cortisol medicine tried firstCigna's employer plans may ask for a trial of Signifor for Cushing disease, or of ketoconazole, Metopirone or Recorlev for other causes. A person who has already started Isturisa also meets this rule. The endocrinologist's office decides how to answer and can document a past trial or a reason.Cigna policy
- Prior authorization pending or deniedCigna asks for age 18 or older, a documented diagnosis of endogenous Cushing syndrome and an endocrinologist. It also wants surgery ruled out or not curative, or the patient awaiting surgery or a radiation response. The policy marks the diagnosis as documentation required, so the office sends chart notes or lab results.Cigna policy
- The pharmacy will not fill the full number of tabletsCigna's quantity policy caps 1mg tablets at 240 and 5mg tablets at 60 per retail fill. It approves more tablets for certain twice-a-day doses listed in the policy. The office can ask for the exception that matches the prescribed dose.Cigna quantity policy
- The prescription went to the wrong pharmacyRecordati says all Isturisa prescriptions are filled through Anovo, its specialty pharmacy. The office sends the Patient Prescription Form to Anovo by fax or through its electronic records system. Questions about the form or the shipment go to R.A.R.E. at 1-888-855-7273.Isturisa HCP support
- A copay you cannot payWith commercial insurance, Recordati offers a $20 co-pay for qualified patients, and eligibility rules apply. Recordati's R.A.R.E. team also helps people identify other financial assistance options. Our help paying page lists charity funds that may cover Cushing syndrome costs.Isturisa patient support
Cigna prior authorization policy, May 1, 2026
- Age 18 or older
- A confirmed diagnosis of endogenous Cushing syndrome, with documentation such as a chart note or lab results
- Surgery is not an option or was not curative, or the patient is waiting for surgery or for a response after radiation
- Prescribed by or with an endocrinologist or a doctor who specializes in Cushing syndrome
- For Cushing disease, a trial of Signifor or Signifor LAR, or already started on Isturisa
- For other causes of Cushing syndrome, a trial of oral ketoconazole, Metopirone or Recorlev, or already started on Isturisa
Approval length. Approved for 1 year. The policy lists no separate renewal criteria.
This version took effect May 1, 2026, after an April 9, 2026 review with no criteria changes. It cites the November 2025 label, which is the current one. Its overview still says pituitary surgery, while the label says surgery. 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 $20 co-pay for qualified patients with commercial insurance, with eligibility requirements, restrictions and limitations
- Help with prior authorization and appeals, and a check of insurance benefits
- Help finding other financial assistance options
- Nurse Educators who check in and answer questions about Isturisa after it starts
- An optional Patient Liaison for disease education and resources, at no cost
- Overnight delivery from Anovo, arranged by a pharmacist once benefits are set, with pharmacy support 24/7 Quick Start Guide
- A patient assistance program for people without insurance who meet financial requirements Recordati support programs
Details as the drugmaker publishes them. Isturisa patient support
Five questions for the pharmacist or the support line
- Which tablets make up my dose, and how many cartons does that mean each month?
- I take these medicines. Do any of them block or speed up CYP3A4, or affect my heart rhythm?
- When my dose changes, does Anovo need a new prescription before the next shipment?
- Does my plan limit how many 1mg or 5mg tablets I can get in one fill?
- Who do I call at night if I think my cortisol is too low?
Questions people ask in the first weeks
How does the Isturisa dose change over time?
The label starts at 2mg twice a day and raises it by 1mg to 2mg twice a day, no more often than every 2 weeks. Above 10mg twice a day, steps of 5mg are allowed. The maximum is 30mg twice a day, and steady doses in the trials varied between 2mg and 7mg twice a day.
What tests come with Isturisa?
The label asks for an ECG and a potassium and magnesium check before the first dose. A second ECG follows within 1 week of the first dose. While the dose is set, two 24-hour urine cortisol tests run every 1 to 2 weeks, then at least every 1 to 2 months.
What does low cortisol feel like on Isturisa?
The Patient Information lists nausea, vomiting, tiredness, low blood pressure, belly pain, loss of appetite, dizziness and low blood sugar. It says to tell the doctor right away, and the doctor may lower the dose or pause it.
What if I miss a dose of Isturisa?
The label says to take the next dose at the usual time. It does not tell people to make up the missed dose.
Is Isturisa only for Cushing disease?
No, since April 15, 2025 the label covers endogenous Cushing syndrome. That includes Cushing disease from a pituitary tumor, when surgery is not an option or did not cure it.
Where does Isturisa come from?
Recordati says all Isturisa prescriptions are filled through Anovo, its specialty pharmacy partner. A pharmacist calls to arrange overnight delivery once insurance is set.
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Sources
- ISTURISA- osilodrostat tablet, coated: prescribing information and Patient Information, revised 11/2025, Recordati Rare Diseases, Inc., via DailyMed, November 18, 2025.
- ISTURISA (osilodrostat) tablets prescribing information and Patient Information, revised 04/2025, FDA, Drugs@FDA, April 15, 2025.
- ISTURISA (osilodrostat) Patient Support, R.A.R.E. Program, Recordati Rare Diseases Inc., November 10, 2026.
- Starting ISTURISA (osilodrostat) for Cushing's, Recordati Rare Diseases Inc., November 10, 2026.
- ISTURISA (osilodrostat), Resources & Support, Recordati Rare Diseases Inc., November 10, 2026.
- ISTURISA (osilodrostat) Patient Prescription Form, ISTURISA.RX.01, revised October 26, 2026, Recordati Rare Diseases Inc. and AnovoRx, October 26, 2026.
- ISTURISA Quick Start Guide, Endogenous Hypercortisolemia in Cushing's Syndrome, PP-IST-US-0674, Recordati Rare Diseases Inc., November 10, 2026.
- Our Focus, Patient Support Programs, Recordati Rare Diseases Inc., November 10, 2026.
- Drug Coverage Policy IP0044, Isturisa (Cushing's, Isturisa), Cigna, May 1, 2026.
- Cushing's Disease, Isturisa Drug Quantity Management Policy, Per Rx, Cigna, May 13, 2026.
- Drugs@FDA record for NDA 212801, Isturisa, via openFDA, FDA, November 10, 2026.
- NDA 212801/S-007 supplement approval letter, corrected, removal of the wallet and sleeve for the blister pack of 20, FDA, November 4, 2025.
- NDA 212801/S-004 supplement approval letter, final results of Clinical Trial C2302 and febrile neutropenia, FDA, July 3, 2025.
- NDA 212801/S-003 supplement approval letter, indication broadened to Cushing's syndrome, FDA, April 15, 2025.
- NDA 212801 approval letter, Isturisa (osilodrostat) tablets, FDA, March 6, 2020.
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.