Your first 90 days
Your first 90 days on Sohonos 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.
Sohonos was approved for FOP in August 2023, and its first fill depends on more than an insurance answer. Anyone who could become pregnant starts birth control a month ahead and takes a pregnancy test in the final week. A child who is still growing has X-rays of the hand, wrist and knee first. After that, the routine is a daily capsule with food and a plan for flare-ups. This page lays out the first 3 months from the FDA label, Ipsen's IPSEN CARES program and one insurer's written rules.
What has to happen before the first bottle ships
Sohonos ships from a specialty pharmacy, so the first fill waits on birth control, a pregnancy test, growth X-rays and an insurance approval. These are the 5 things in the way, in order.
Birth control at least 1 month before the first dose
Sohonos can cause birth defects, and the label says it may only be given when pregnancy prevention conditions are met.
- Anyone who could become pregnant uses effective birth control from at least 1 month before treatment until 1 month after the last dose.
- The counseling section names one highly effective method such as an IUD, or combined hormonal birth control plus a barrier method.
- The label also allows continuous abstinence as the method of prevention.FDA label
A negative blood pregnancy test within 1 week before starting
The label asks for a negative serum pregnancy test within 1 week before the first dose.
- It adds more tests during treatment and 1 month after stopping.
- The Medication Guide says Sohonos is only for people who can understand and follow every pregnancy prevention instruction.
- The label's counseling section speaks to the patient and caregiver, so a parent or guardian can be part of that conversation.FDA label
Growth X-rays for anyone still growing
Sohonos can close growth plates early in children who are still growing, and the label says the change is permanent.
- Before the first dose, every growing child needs X-rays of the hand, wrist and knee, a standard growth chart and a puberty check.
- The label sets the age floor at 8 for girls and 10 for boys for this reason.FDA label
A medicine and vitamin review
Sohonos is cleared mainly by the liver enzyme CYP3A4, so medicines that block or speed that enzyme change how much reaches the blood.
- The label also says to avoid tetracycline antibiotics and vitamin A above the daily allowance.
- Bring every prescription, over-the-counter medicine, vitamin and herbal product to the review.FDA label
IPSEN CARES, and the insurance approval
The prescriber's office starts the IPSEN CARES enrollment, and the patient, or a guardian, signs the Patient Authorization section.
- A Patient Access Manager then checks coverage, says whether the plan needs prior authorization, and explains the appeal process if one is needed.
- Once coverage is in place, IPSEN CARES can route the prescription to a specialty pharmacy.IPSEN CARES
The days that matter
Counted from the first dose, with the pregnancy and growth steps before it, the 28-day refill, and the checks that continue past day 90. 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.Birth control starts, if pregnancy is possible
The label requires effective birth control from at least 1 month before the first dose.
- This page places it 5 weeks out so that the full month is complete by day 1.
IPSEN CARES enrollment and the insurance check
The prescriber's office sends the enrollment form, signed by the patient or a guardian.
- A Patient Access Manager checks coverage and says whether prior authorization is needed.
Hand, wrist and knee X-rays for a growing child
The label asks for these X-rays, a standard growth chart and a puberty check before treatment.
- Adults and teenagers who have finished growing do not need this step.
Blood pregnancy test
For anyone who could become pregnant, the label asks for a negative serum pregnancy test within 1 week before the first dose.
The specialty pharmacy ships
IPSEN CARES routes prescriptions to a limited network of specialty pharmacies, and its form lists CVS Specialty as preferred.
- IPSEN CARES forwards the prescription to the chosen pharmacy once coverage is secured.
First dose, with food
One daily dose with food, ideally at the same time each day.
- The capsules come in blister strips of 14 in a child-resistant carton, kept in the carton away from light.
Two weeks in: skin, lips and eyes
Skin, lip and eye reactions such as dryness, itching and peeling affected 98% of patients in the studies.
- The label recommends moisturizers, lip balm, sunscreen and artificial tears to prevent or treat them.
Refill, then about every 28 days
The IPSEN CARES form writes each prescription as a 28-day supply.
- A flare-up dose is different from the daily dose, so the flare-up prescription needs to reach the pharmacy quickly.
Refill, number 2
Refill, number 3
Three months in, and the checks ahead
The label recommends growth checks every 6 to 12 months until a child finishes growing.
- It also recommends periodic spine imaging and periodic pregnancy tests.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Sohonos 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.
Label dated September 24, 2026, read on DailyMed. FDA label
- September 2026
The dosing section now says several 1mg, 1.5mg or 5mg capsules should not replace a single 10mg capsule. A study in 72 healthy volunteers found peak blood levels 31% higher with four 2.5mg capsules than with one 10mg capsule.FDA label
- March 2025
The FDA approved a supplement on March 13, 2025, and the Medication Guide in use today carries a March 2025 date. The approval letter could not be opened for this page, so the changes are not described here.Drugs@FDA
- August 2023
The FDA approved Sohonos for FOP on August 16, 2023, with no REMS. It required a long-term safety registry that also collects information on pregnancies during treatment.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.
- Once a day, with food
The label says to take Sohonos with food, preferably at the same time each day.
- The daily dose is 5mg from age 14, and under 14 it goes by weight.
- It runs from 2.5mg at 10kg to 19.9kg (about 22 to 44 pounds) up to 5mg from 60kg (about 132 pounds).FDA label
- Opening the capsule onto food
Anyone who cannot swallow the capsule can open it onto 1 teaspoon of soft food such as applesauce, low-fat yogurt or warm oatmeal.
- The label says to take it within 1 hour, kept at room temperature and out of direct sunlight.FDA label
- Flare-up doses
The label starts flare-up dosing at the first symptom of a flare-up, such as pain, swelling, redness, warmth or stiffness.
- From age 14 that means 20mg a day for 4 weeks, then 10mg a day for 8 weeks, then back to 5mg.
- Children under 14 follow the label's own weight-based flare-up table instead.
- The FOP specialist decides when a flare-up course starts or restarts.FDA label
- Events that can set off a flare-up
The label lists surgery, a shot into a muscle, a dental nerve block, muscle fatigue, falls, bumps and flu-like illness as high-risk events.
- It allows flare-up dosing to start at such an event.
- Planned procedures are worth raising with the FOP specialist ahead of time.FDA label
- Capsule strengths are not interchangeable
Since September 2026 the label says several 1mg, 1.5mg or 5mg capsules should not replace a single 10mg capsule.
- In a study, smaller capsules taken together gave higher peak blood levels than one 10mg capsule.FDA label
- If a dose is missed
The label says to take it as soon as possible, unless more than 6 hours have passed.
- In that case the missed dose is skipped and the next one taken on schedule.
- Two doses are never taken at once or on the same day.FDA label
- Grapefruit, vitamin A and some antibiotics
The label rules out grapefruit, pomelo and juices containing them during treatment.
- It also says to avoid vitamin A above the daily allowance, other oral retinoids, and tetracycline antibiotics.
- Medicines that strongly or moderately affect CYP3A4 are also on its list to avoid.FDA label
- Sun, night driving and blood donation
Sohonos can make skin burn more easily, so the Medication Guide advises sunscreen, sunglasses and covering clothes.
- It can reduce vision in the dark, which matters for anyone who drives at night.
- The label also rules out blood donation during treatment and for 1 week after.FDA label
- Breastfeeding, storage and children
The label does not recommend breastfeeding during treatment or for at least 1 month after the last dose.
- The label says to store cartons at room temperature, 68 to 77 degrees Fahrenheit, out of the 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.
Mood changes and suicidal thoughts
The label reports new or worse depression, anxiety, mood changes and suicidal thoughts and behaviors on Sohonos.
- It says patients and caregivers should contact the healthcare provider if these appear or worsen.
- A history of mental health problems may raise the risk.FDA label
A possible pregnancy
The Medication Guide says anyone who becomes pregnant, or thinks they may be, should stop taking Sohonos and call the healthcare provider right away.
- The label then refers the patient to an obstetrician or gynecologist experienced in reproductive toxicity.FDA label
Trouble seeing in the dark
Night blindness can occur with Sohonos and may make driving at night unsafe.
- The Medication Guide says the provider should send anyone with vision problems to an eye specialist.FDA label
Skin problems and skin infections
Dry or peeling skin weakens the skin barrier, raising the risk of skin infections.
- The label names infections around the nails and pressure sores in particular.
- Some people need a lower dose for skin reactions, which the prescriber decides.FDA label
Growth, spine and bone thinning
In the studies, early growth plate closure was found in 27% of patients under 18, and in none who started at 14 or older.
- Sohonos also reduced spinal bone density and raised the rate of spine fractures seen on scans.
- The label asks for growth X-rays and periodic spine imaging to watch for both.FDA label
Signs of too much
The label lists severe headache, nausea or vomiting, drowsiness, irritability and itching as possible signs of an overdose.
- The label calls them signs of too much vitamin A, since Sohonos is a vitamin A derivative.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 deniedPlans ask for the criteria below, most often the age floor, a genetic test, X-ray or scan evidence of extra bone, and a specialist. IPSEN CARES checks coverage, says whether prior authorization is needed and explains the appeal process.IPSEN CARES
- The genetic test shows a variant other than R206HThe Cigna policy below asks for a documented genetic test confirming the R206H variant specifically. A different ACVR1 variant does not meet that criterion as written, and other plans may word it differently.Cigna policy
- The prescription went to a pharmacy outside the networkSohonos goes through a limited network of specialty pharmacies, and the IPSEN CARES form lists CVS Specialty as preferred. IPSEN CARES can send the prescription to the right pharmacy, since this is a routing problem rather than a denial.IPSEN CARES enrollment
- A flare-up starts and the new strengths are not on fileThe IPSEN CARES prescription form has separate lines for the daily dose, flare-up weeks 1 to 4 and flare-up weeks 5 to 12. Asking the specialist's office whether flare-up prescriptions are already at the pharmacy saves time later.IPSEN CARES enrollment
- A copay you cannot payWith commercial insurance, the Sohonos copay program may help, up to an annual maximum. Its terms exclude anyone in Medicare, Medicaid, Medigap, VA, DoD or TRICARE. They also exclude anyone getting help from another assistance program or foundation in the same enrollment year.Copay terms
- No insuranceThe Sohonos Patient Assistance Program may supply the drug free to people who are uninsured or functionally uninsured and meet financial rules. Enrollment in IPSEN CARES is required to apply, and eligibility does not guarantee a place.IPSEN CARES assistance
Cigna prior authorization policy, December 15, 2025
- Female and 8 or older, or male and 10 or older, with sex defined in the policy by biological traits
- A genetic test confirming the ACVR1 R206H variant, with documentation
- Heterotopic ossification, meaning bone in soft tissue, confirmed by X-ray, CT, MRI or PET
- Prescribed by or in consultation with an endocrinologist or a physician who specializes in bone disease
Approval length. 1 year at a time.
This policy took effect on December 15, 2025, and cites the March 2025 label. The September 2026 revision changed dosing guidance on capsule strengths, not who qualifies. Cigna asks for the R206H variant specifically, while the label's approved use names FOP without a variant. Other plans set their own criteria, and some may differ. 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.
- Patient Access Managers who check coverage, say whether prior authorization is needed and explain the appeal process
- The Sohonos Copay Assistance Program for commercial insurance that covers Sohonos, as little as $0 per prescription, not open to anyone with state or federal healthcare coverage IPSEN CARES assistance
- An annual maximum on the copay benefit, and no copay help in a year when another assistance program or foundation is already helping Copay terms
- The Sohonos Patient Assistance Program, free drug for people who are uninsured or functionally uninsured and meet financial rules IPSEN CARES assistance
- Routing of the prescription to the right specialty pharmacy once coverage is in place
- Patient Education Liaisons who explain FOP and Sohonos for as long as the patient is enrolled, without giving medical advice
Details as the drugmaker publishes them. IPSEN CARES
Five questions for the pharmacist or the support line
- Which capsule strengths make up the daily dose, and how many capsules is that each day?
- Is a flare-up prescription already on file, and how quickly can you ship it if a flare-up starts?
- Does the flare-up dose use 10mg capsules, given the label's rule about substituting smaller ones?
- Are any of these medicines, vitamins or supplements on the Sohonos interaction list?
- Is it safe to open the capsule onto applesauce for someone who cannot swallow it?
Questions people ask in the first weeks
How long does it take to get Sohonos after it is prescribed?
There is no fixed number of days, because several steps have to line up. Anyone who could become pregnant needs birth control for at least 1 month first, and a pregnancy test within the last week. Growing children need hand, wrist and knee X-rays before the first dose. The insurance check and specialty pharmacy setup run alongside those steps.
Does Sohonos have a REMS?
Sohonos has no REMS, and the FDA's August 2023 approval letter includes no REMS requirement. The boxed warning still says Sohonos may only be given when pregnancy prevention conditions are met.
Can I pick up Sohonos at my regular pharmacy?
Usually not, because IPSEN CARES routes prescriptions to a limited network of specialty pharmacies, and its form lists CVS Specialty as the preferred pharmacy.
What happens to the Sohonos dose during a flare-up?
From age 14, the label raises the dose to 20mg a day for 4 weeks, then 10mg a day for 8 weeks. Children under 14 follow a weight-based table in the label instead. The course restarts if the flare-up gets markedly worse or a new one starts, as the specialist decides.
What if a dose of Sohonos is missed?
The label says to take it as soon as possible, unless more than 6 hours have passed. After 6 hours the dose is skipped, and two doses are never taken on the same day.
Why does a child need X-rays before Sohonos?
Sohonos can close growth plates early in a growing child, and the label calls that change irreversible. X-rays of the hand, wrist and knee show how mature the bones are before treatment begins. The label recommends repeat checks every 6 to 12 months until growth is complete.
Why was Sohonos denied by my insurance?
The Cigna policy on this page asks for the age floor, a genetic test, imaging showing extra bone, and a specialist. Cigna asks for the R206H variant of the ACVR1 gene specifically, and other plans set their own rules. The label's approved use names FOP without a variant, which may matter in an appeal.
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Sources
- SOHONOS (palovarotene) capsules prescribing information and Medication Guide, revised September 2026, Ipsen Biopharmaceuticals, via DailyMed, September 24, 2026.
- Sohonos HCP Patient Support Services, IPSEN CARES, Ipsen, November 9, 2026.
- Enroll Your Patient in Sohonos Support Program, IPSEN CARES enrollment form, Ipsen, November 9, 2026.
- Sohonos Copay & Patient Assistance Details for HCPs, Ipsen, November 9, 2026.
- IPSEN CARES Copay Eligibility, Terms & Conditions (Bylvay, Iqirvo, Sohonos), Ipsen, November 9, 2026.
- Drug Coverage Policy IP0596, Sohonos, Cigna, December 15, 2025.
- NDA 215559 approval letter, Sohonos (palovarotene) capsules, FDA, August 16, 2023.
- Drugs@FDA record for NDA 215559, submission history, via openFDA, FDA, November 9, 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.