Prescribing guide
Sohonos (palovarotene)Pregnancy prevention, skeletal maturity baseline, flare-up dosing and prior authorization criteria for FOPFor prescribers and their offices treating fibrodysplasia ossificans progressiva (FOP): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
Effective contraception from at least 1 month before the first dose and a negative serum pregnancy test within 1 week before it, in females of reproductive potential; baseline skeletal maturity in growing patients; IPSEN CARES enrollment, benefits verification and routing to a limited specialty pharmacy network. No REMS.
Example PA threshold
Cigna example: female 8 or older or male 10 or older, a documented ACVR1 R206H genetic test, radiologically confirmed heterotopic ossification, an endocrinologist or bone disease specialist; 1-year approval.
Monitoring
Pregnancy tests periodically and 1 month after stopping; growth and skeletal maturity every 6 to 12 months to final height; periodic spine imaging for vertebral fracture; mood and psychiatric symptoms; night vision.
Support line
IPSEN CARES, 866-435-5677, Monday to Friday 8 AM to 8 PM ET, Patient Access Managers for benefits verification and PA, copay as little as $0 for commercial plans, a Patient Assistance Program for the uninsured or functionally uninsured, and specialty pharmacy triage.
Give your patient their plan
A one-page handout for starting Sohonos, 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/sohonosBefore 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 |
|---|---|---|
| Contraception | Females of reproductive potential use effective contraception from at least 1 month before treatment to 1 month after the last dose, unless continuous abstinence is chosen. Counseling names at least one highly effective method such as an IUD, or two effective methods such as combined hormonal contraception with a barrier method. | FDA label |
| Serum pregnancy test | Negative within 1 week before initiation; periodically during treatment and 1 month after discontinuation unless not at risk of pregnancy. If pregnancy occurs, stop Sohonos and refer to an obstetrician or gynecologist experienced in reproductive toxicity. | FDA label |
| Baseline skeletal maturity | In every growing patient: hand and wrist and knee X-rays, standard growth curves and pubertal staging. Not recommended under 8 in females or under 10 in males because of premature epiphyseal closure. | FDA label |
| Medication reconciliation | Avoid strong and moderate CYP3A4 inhibitors and inducers, tetracyclines, vitamin A above the RDA and other oral retinoids. Not recommended in severe renal impairment or in moderate or severe hepatic impairment. | FDA label |
| IPSEN CARES enrollment | The office starts enrollment; the patient signs the Patient Authorization. IPSEN CARES verifies benefits, advises whether a PA is required, gives appeal process information and directs the prescription to a specialty pharmacy once coverage is secured. | IPSEN CARES |
| Prescription | The IPSEN CARES form writes daily, flare-up weeks 1 to 4 and flare-up weeks 5 to 12 lines separately, each as a 28-day supply, from 1mg, 1.5mg, 5mg and 10mg capsules. It lists CVS Specialty as preferred, with triage to the limited specialty pharmacy network. | IPSEN CARES enrollment |
Prior authorization criteria and what to document
One public policy as the example: Cigna, December 15, 2025. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age and sex | Female 8 or older, or male 10 or older, with sex defined by biological traits | Date of birth and sex on the request | Cigna policy |
| Genetic test | Pathogenic ACVR1 R206H variant consistent with FOP, documentation required | The genetic test report; the label's indication names FOP without a variant, which may matter in an appeal for other ACVR1 variants | Cigna policy |
| Heterotopic ossification | Confirmed by radiologic testing such as X-ray, CT, MRI or PET | The imaging report with date | Cigna policy |
| Prescriber | Prescribed by or in consultation with an endocrinologist or a physician who specializes in bone disease | Specialty on the request, or the consult note | Cigna policy |
| Approval | 1 year; the policy cites the March 2025 label and predates the September 2026 revision, which changed capsule substitution guidance only | Renewal date in the chart | Cigna policy |
Sohonos dosing and titration
| When | Label | Source |
|---|---|---|
| 14 and older, daily | 5mg once daily with food, preferably at the same time each day. Swallowed whole, or opened onto 1 teaspoon of soft food and taken within 1 hour. Stop daily dosing when flare-up dosing begins. | FDA label |
| 14 and older, flare-up | 20mg daily for 4 weeks, then 10mg daily for 8 weeks, even if symptoms resolve, then back to 5mg. Restart at 20mg for marked worsening or a new site; extend 10mg in 4-week intervals for unresolved symptoms. | FDA label |
| Under 14, by weight | Daily, weeks 1 to 4 and weeks 5 to 12 flare-up: 10 to 19.9kg 2.5mg, 10mg, 5mg; 20 to 39.9kg 3mg, 12.5mg, 6mg; 40 to 59.9kg 4mg, 15mg, 7.5mg; 60kg or more 5mg, 20mg, 10mg. | FDA label |
| When to start flare-up dosing | At the first symptom of a flare-up (localized pain, swelling, redness, warmth, reduced range of motion, stiffness) or a substantial high-risk traumatic event such as surgery, IM immunization, mandibular block, blunt trauma, falls or influenza-like illness. | FDA label |
| Capsule substitution | Since 09/2026: multiple 1mg, 1.5mg or 5mg capsules should not be substituted for a single 10mg capsule. Four 2.5mg capsules gave a 31% higher Cmax and two 5mg capsules a 17% higher Cmax than one 10mg capsule in 72 healthy subjects. | FDA label |
| Adverse reactions | Reduce to the next lower dose per Table 2 (for example 20mg to 15mg, 5mg to 2.5mg); consider temporary or permanent discontinuation at the lowest tolerated dose. Start later flare-ups at the reduced dose. | FDA label |
| Missed dose | Take as soon as possible; skip if more than 6 hours late; never 2 doses at once or on the same day. | FDA label |
| Supply | Blister strips of 14 capsules in a child-resistant carton; store at 20 to 25°C in the original carton to protect from light. | FDA label |
Monitoring the Sohonos label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Serum pregnancy test within 1 week; skeletal maturity X-rays, growth curves and pubertal staging in growing patients | Required before initiation by the label | FDA label |
| Every 6 to 12 months | Linear growth and skeletal maturity in growing patients | Until skeletal maturity or final adult height; closure was seen as early as 6 months, most at or after 12 months; consider interruption or discontinuation if signs appear | FDA label |
| Periodically | Pregnancy test; radiologic spine assessment | Decreased vertebral BMD and increased radiologic vertebral fractures (T4 to L4) versus untreated patients | FDA label |
| Any time | Depression, anxiety, mood changes, suicidal thoughts and behaviors | Monitor and refer as needed; higher risk with a psychiatric history | FDA label |
| Any time | Mucocutaneous reactions and skin infection, especially paronychia and decubitus ulcer | 98% had mucocutaneous reactions; dose reductions for them were 37% during flare-up and 4% during chronic dosing | FDA label |
| Any time | Night blindness, photosensitivity | Caution with night driving; refer for vision impairment; sun protection | FDA label |
| Reported in studies | ALT; triglycerides | Elevated ALT in 7.0% during flare-up and 1% during chronic dosing; hypertriglyceridemia in 4% and 2%; none led to reduction or discontinuation for ALT | FDA label |
Sohonos drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Strong CYP3A4 inhibitors | Avoid. Ketoconazole raised Cmax 2-fold and AUC 3-fold. | FDA label |
| Moderate CYP3A4 inhibitors | Avoid if possible; if unavoidable, halve the dose per Table 3. Erythromycin raised Cmax 1.6-fold and AUC 2.5-fold. | FDA label |
| Strong or moderate CYP3A4 inducers | Avoid; may reduce effectiveness. | FDA label |
| Vitamin A and oral retinoids | Avoid vitamin A above the RDA and other oral retinoids because of hypervitaminosis A. | FDA label |
| Tetracyclines | Avoid; systemic retinoids with tetracyclines have been linked to benign intracranial hypertension. | FDA label |
| Grapefruit and pomelo | Do not give with grapefruit, pomelo or their juices. | FDA label |
| Systemic corticosteroids | No clinically significant interaction expected with prednisone. | FDA label |
| Pregnancy, lactation, blood donation | Contraindicated in pregnancy; breastfeeding not recommended during treatment and for at least 1 month after; no blood donation during treatment and for 1 week after. | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
Questions prescribers' offices ask about Sohonos
What is the Sohonos dose for FOP?
The September 2026 label gives 5mg once daily with food for adults and patients 14 and older, and 20mg daily for 4 weeks then 10mg daily for 8 weeks at a flare-up. Under 14 the daily dose is weight-based from 2.5mg to 5mg, with flare-up doses from Table 1. The 12-week course restarts at the week 1 dose for marked worsening or a new flare-up site.
What pregnancy testing does Sohonos require?
The September 2026 label requires a negative serum pregnancy test within 1 week before the first dose in females of reproductive potential. It adds testing periodically during treatment and 1 month after discontinuation, and effective contraception from at least 1 month before treatment to 1 month after the last dose, unless continuous abstinence is chosen.
What growth monitoring does Sohonos require in children?
The September 2026 label recommends baseline hand and wrist and knee X-rays, standard growth curves and pubertal staging in every growing patient, then monitoring every 6 to 12 months to skeletal maturity or final adult height. Premature epiphyseal closure was identified in 27% of subjects under 18 at enrollment, and in none who were 14 or older.
Does Sohonos have a REMS?
No REMS appears in the August 16, 2023 approval letter, and the September 2026 label names none. The boxed warning still restricts use to patients who meet pregnancy prevention conditions.
What do insurers ask for to approve Sohonos?
The Cigna policy shown on this page, effective December 15, 2025, asks for the age floor of 8 for females and 10 for males, a documented ACVR1 R206H genetic test, radiologically confirmed heterotopic ossification, and an endocrinologist or bone disease specialist. Approval runs 1 year.
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Sources
- SOHONOS (palovarotene) capsules prescribing information and Medication Guide, revised September 2026, Ipsen Biopharmaceuticals, via DailyMed, 2026-09-24.
- Sohonos HCP Patient Support Services, IPSEN CARES, Ipsen, 2026-11-09.
- Enroll Your Patient in Sohonos Support Program, IPSEN CARES enrollment form, Ipsen, 2026-11-09.
- Sohonos Copay & Patient Assistance Details for HCPs, Ipsen, 2026-11-09.
- IPSEN CARES Copay Eligibility, Terms & Conditions (Bylvay, Iqirvo, Sohonos), Ipsen, 2026-11-09.
- Drug Coverage Policy IP0596, Sohonos, Cigna, 2025-12-15.
- NDA 215559 approval letter, Sohonos (palovarotene) capsules, FDA, 2023-08-16.
- Drugs@FDA record for NDA 215559, submission history, via openFDA, FDA, 2026-11-09.
A reference drawn from the September 24, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 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.