Your first 90 days
Your first 90 days on Atebrioz for FOP
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.
Atebrioz is a once-a-day pill, so the wait before the first bottle is mostly paperwork. The FOP specialist's office sends an enrollment form, the insurance plan reviews it, and anyone who can become pregnant has a pregnancy check first. After that the routine is four tablets a day and a refill every 30 days. This page lays out those first 3 months from the FDA label, Mirum's support program and what insurers have published so far.
What has to happen before the first bottle ships
Atebrioz has no REMS, so the first fill waits on a pregnancy check where it applies, an enrollment form and an insurance approval. These are the 7 things in the way, in order.
A pregnancy check, where it applies
The label lists pregnancy as the only condition in which Atebrioz must not be used.
- For anyone who can become pregnant, the specialist confirms there is no pregnancy before the first dose.
- The Medication Guide says the healthcare provider will ask for a pregnancy test.FDA label
A plan for birth control and breastfeeding
The label calls for effective birth control during treatment and for 1 week after the last dose.
- The Medication Guide suggests talking with the healthcare provider about which methods may be right.
- Breastfeeding is not recommended during treatment or for at least 1 week after the last dose.FDA label
A full list of medicines and supplements
The enzyme CYP3A4 breaks Atebrioz down, and Atebrioz can raise the level of metformin, a diabetes medicine.
- The label asks patients to tell their healthcare providers about every medicine, herbal product and dietary supplement.
- Some combinations lower the Atebrioz dose, and the label says others should be avoided.FDA label
The enrollment form and a signed consent
The specialist's office faxes the Atebrioz Patient Enrollment Form to Mirum Access Plus, called MAP, with a copy of the insurance card.
- The patient, or a parent, guardian or other authorized representative, signs the consent section.
- That signature lets MAP work with the insurance plan and the pharmacy.MAP enrollment form
The insurance approval
After the enrollment form arrives, MAP checks the insurance benefits and gives the office a detailed coverage overview.
- MAP also answers the office's questions about the prior authorization process.
- If the plan says no at first, MAP's Regional Access Specialists help the office with the appeal.MAP for prescribers
If the insurance decision is slow
The enrollment form has a box for the Urgent Patient Access Program.
- The prescriber ticks it when there is an urgent medical need and an access barrier of at least 5 business days.
- If approved, eligible patients receive an initial 15-day supply, and a longer barrier may qualify them for more, up to 60 days in total.MAP enrollment form
Delivery to your door
Atebrioz ships to your doorstep from the MAP pharmacy, according to Mirum.
- Before the first bottle goes out, the pharmacy calls to confirm your shipping information, so it helps to answer calls from unfamiliar numbers.Mirum Access Plus
The days that matter
Counted from the first dose, with the paperwork in the weeks before it and a refill every 30 days from a 120-tablet bottle. 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.MAP welcome call and insurance check
After the prescription, a MAP Patient Navigator calls to welcome you and collect insurance details.
- MAP then reviews your benefits and looks at options for financial support.
Pregnancy check, where it applies
For anyone who can become pregnant, the label asks the specialist to confirm there is no pregnancy before the first dose.
- Effective birth control is needed from the first dose until 1 week after the last one.
The delivery call
Once the plan approves, you get a call from the MAP pharmacy to confirm your shipping information.
- After that call, the pharmacy sends the first bottle to your door.
First dose, four tablets once a day
Four 25mg tablets make the 100mg dose, taken once a day with or without food.
- A bottle holds 120 tablets, which lasts 30 days at this dose.
Two weeks in
Headache, joint pain, colds, nosebleeds and nausea were the most common side effects in the main study.
- This is a reasonable point to tell the specialist's office about any of them and to confirm the first refill.
Refill, then every 30 days
A 120-tablet bottle runs out here at 4 tablets a day.
- At the lower 50mg dose the label sets for some interacting medicines, a bottle lasts 60 days.
Refill, number 2
Keeping records for renewal
Mirum's prior authorization checklist lists what a plan may ask for at renewal.
- One or more may be needed, such as imaging showing less new bone, joint scores unchanged or better, steady flare-ups, or less steroid use.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Atebrioz 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.
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.
- Four tablets, once a day
The label dose is 100mg once a day, given as four 25mg tablets, with or without food.
- Each tablet is white to off-white, round, and stamped INCY on one side and 25 on the other.FDA label
- Whole or crushed
The label allows the tablets to be swallowed whole or crushed.
- Crushed tablets are mixed into 4 tablespoons (60mL) of water, orange juice, applesauce or plain yogurt.
- The mixture is taken right away and never saved for later.FDA label
- No grapefruit or pomelo
The label says not to take Atebrioz with grapefruit, pomelo or juices that contain these fruits.
- Its list of liquids for mixing crushed tablets is water, orange juice, applesauce or plain yogurt.FDA label
- If a dose is missed
Neither the label nor the Medication Guide says what to do after a missed dose.
- The Medication Guide says not to change the dose or stop Atebrioz without first talking to the healthcare provider.
- Ask the specialist or pharmacist for their instruction ahead of time.FDA label
- Medicines that change the dose
With a strong CYP3A4 blocker, such as the antifungal itraconazole, the label lowers the dose to 50mg once a day.
- Mild or moderate blockers need no change in the dose, by the label.
- The label says to avoid strong or moderate CYP3A4 inducers, such as rifampin, which can make Atebrioz work less well.FDA label
- Metformin and similar medicines
Atebrioz can raise the level of medicines carried by the MATE1 and MATE2-K transporters, such as metformin.
- The label says to avoid the combination, and if it cannot be avoided, to watch for side effects and consider lowering the other medicine.FDA label
- Pregnancy, birth control and breastfeeding
The label lists pregnancy as a contraindication, based on animal studies and on how the medicine works.
- Effective birth control is needed during treatment and for 1 week after the last dose.
- The Medication Guide says anyone who becomes pregnant should stop Atebrioz immediately and call their healthcare provider.
- Breastfeeding is not recommended until at least 1 week after the last dose.FDA label
- Storage
The Medication Guide says to store the tablets at 68 to 77 degrees Fahrenheit in the original bottle.
- The bottle has a child-resistant cap, and the guide says to keep it and all medicines out of reach of children.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.
A possible pregnancy
The Medication Guide says anyone who becomes pregnant, or thinks they may be, should stop taking Atebrioz immediately and call their healthcare provider right away.
- It warns of harm to an unborn baby, including birth defects, based on animal studies.FDA label
The most common side effects
In the main study through week 24, headache, joint pain and colds or sinus infections each affected 22% of people on Atebrioz.
- On placebo, headache affected 16%, and joint pain and colds affected 10% each.
- Nosebleeds affected 13% against none on placebo, and nausea 13% against 3%.FDA label
Less common side effects
Gastroenteritis (stomach flu), acid reflux, iron deficiency anemia and rash each occurred in 3 people on Atebrioz, and hair loss in 2.
- None of these side effects were reported in the placebo group.
- The Medication Guide says to call your doctor for medical advice about side effects.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.
- Prior authorization pending or deniedWe found no public insurer policy for Atebrioz as of November 9, 2026. Mirum's checklist says plans without a policy may ask for genetic test results, CT or MRI images, and chart notes on flare-ups. It also lists a specialist prescriber, or a consult with an endocrinologist, rheumatologist, geneticist, orthopedic specialist or bone specialist.Mirum PA checklist
- The plan said no at firstMAP's Regional Access Specialists work with the specialist's office on the appeal. MAP also offers offices a sample letter of medical necessity and a tip sheet for the appeals process.MAP for prescribers
- The plan is slow to decideThe prescriber can tick the Urgent Patient Access Program box when an urgent need meets an access barrier of at least 5 business days. If approved, eligible patients get an initial 15-day supply, and a longer barrier may qualify them for up to 60 days.MAP enrollment form
- Another FOP medicine is on fileBlue Cross Blue Shield of Michigan's criteria, effective January 1, 2027, say Sohonos is not to be used together with Atebrioz or Pasatru. The specialist's office can send the plan the dates of any earlier FOP treatment.BCBS Michigan criteria
- A copay you cannot payEligible patients with commercial or private insurance may pay as little as $0 per fill through the MAP Savings Program. The Mirum Patient Assistance Program helps people who qualify, and MAP checks eligibility for both.Mirum Access Plus
- Medicare, Medicaid, TRICARE or VA coverageThe enrollment form says patients in a federal healthcare program, including these, may not be eligible for certain Mirum financial assistance programs. The form says eligibility for each program is assessed under federal and state law.MAP enrollment form
- The patient is under 12The label covers adults and children 12 and older and says safety and effectiveness have not been established in younger children. The specialist can explain what that means for a younger child.FDA label
Checked November 9, 2026
On November 9, 2026 we searched public policies from Express Scripts, FEP Blue, Aetna, Cigna and others and found no Atebrioz criteria. Until plans publish their own, Mirum's checklist lists what a plan without a policy may ask for, such as genetic tests and imaging. That checklist is a drugmaker's guide, not an insurer's rule. Mirum PA checklist
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 Patient Navigator who answers questions about Atebrioz and your insurance coverage and looks for financial assistance
- A benefits check and coverage overview after the enrollment form, and Regional Access Specialists who help the office with prior authorization and appeals
- The MAP Savings Program, as little as $0 out of pocket per fill for eligible patients with commercial or private insurance, subject to program terms
- The Mirum Patient Assistance Program for people who qualify for financial support
- An Urgent Patient Access Program with an initial 15-day supply when an urgent need meets an access barrier, such as a coverage delay, of at least 5 business days, and possibly more up to 60 days in total MAP enrollment form
- Patients in Medicare, Medicaid, TRICARE, VA or another federal program may not be eligible for certain Mirum financial assistance programs MAP enrollment form
- Home delivery from the MAP pharmacy, which calls to confirm your shipping information, with support through every refill Mirum Access Plus
- MAP Mobile, an online tool for prescription updates and refills, which Mirum says will be available to Atebrioz patients in 2027 MAP brochure
Details as the drugmaker publishes them. MAP for prescribers
Five questions for the pharmacist or the support line
- Which pharmacy will ship Atebrioz, and what number will the delivery call come from?
- These are all my medicines and supplements. Are any of them strong CYP3A4 blockers, CYP3A4 inducers or MATE substrates such as metformin?
- The label does not say what to do after a missed dose. What should I do if one is missed?
- If another doctor prescribes an antibiotic or antifungal, who checks it against Atebrioz first?
- How many days before the bottle runs out should the refill be requested?
- Does the insurance plan need anything new from the specialist before a refill or renewal?
Questions people ask in the first weeks
How long does it take to get Atebrioz after it is prescribed?
There is no fixed number, because the enrollment form, the insurance review and any pregnancy check each take their own time. With an urgent need and an access barrier of at least 5 business days, MAP's Urgent Patient Access Program may send a 15-day supply.
Can Atebrioz tablets be crushed?
Yes, the label allows the tablets to be swallowed whole or crushed. All 4 tablets can be mixed into 4 tablespoons (60mL) of water, orange juice, applesauce or plain yogurt. The label says to take the mixture right away and never store it.
Can a 12-year-old take Atebrioz?
Yes, the FDA approved Atebrioz for adults and children 12 and older with FOP. The label says safety and effectiveness under age 12 have not been established. Mirum said in September 2026 that studies in children aged 2 to under 12 are continuing.
What if I miss a dose of Atebrioz?
The label and the Medication Guide do not give a missed-dose instruction. The Medication Guide says not to change the dose or stop Atebrioz without first talking to your healthcare provider. Ask the specialist or pharmacist what to do before it happens.
Does Atebrioz need blood tests?
The label does not set any scheduled blood test for Atebrioz. In the main study, average iron, hemoglobin and transferrin saturation rose on Atebrioz but stayed within the normal range. The specialist decides which tests, scans or joint checks to follow.
Does Atebrioz have a boxed warning or a REMS?
Neither one applies to Atebrioz under its September 2026 label. The label has no boxed warning, and the FDA's approval letter does not require a REMS. Pregnancy is the one condition in which the label says Atebrioz must not be used.
Why was Atebrioz denied by my insurance?
We found no public insurer policy for Atebrioz as of November 9, 2026. Mirum's checklist says plans without a policy may ask for genetic test results, CT or MRI images and chart notes. MAP's Regional Access Specialists help the specialist's office with appeals.
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Sources
- ATEBRIOZ (zilurgisertib) tablets, for oral use, prescribing information and Medication Guide, Revised 9/2026, Mirum Pharmaceuticals, via FDA Drugs@FDA, September 25, 2026.
- NDA 221198 approval letter, Atebrioz (zilurgisertib) tablets, FDA, September 25, 2026.
- FDA Approves Third Treatment for Fibrodysplasia Ossificans Progressiva, FDA, September 25, 2026.
- Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of ATEBRIOZ™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva, Mirum Pharmaceuticals, September 25, 2026.
- ATEBRIOZ™ (zilurgisertib) Patient Support | Mirum Access Plus®, Mirum Pharmaceuticals, November 9, 2026.
- ATEBRIOZ™ (zilurgisertib) HCP Support | Mirum Access Plus®, Mirum Pharmaceuticals, November 9, 2026.
- ATEBRIOZ (zilurgisertib) Tablets Patient Enrollment Form, September 2026 version, Mirum Pharmaceuticals, November 9, 2026.
- Prior Authorization (PA) Informational Checklist for Atebrioz, October 2026 version, Mirum Pharmaceuticals, November 9, 2026.
- Mirum Access Plus brochure for ATEBRIOZ, September 2026 version, Mirum Pharmaceuticals, November 9, 2026.
- Prior authorization and step therapy coverage criteria, November 2026, Sohonos entry, Blue Cross Blue Shield of Michigan and Blue Care Network, November 1, 2026.
- To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (Progress), NCT05090891, ClinicalTrials.gov, record updated October 22, 2026, October 22, 2026.
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 FOP specialist. Found an error? Use the report link in the footer and it will be checked against the source.