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SOHONOS palovarotene 10 mg Capsule, 14-count — NDC 15054-0100-01 package photo

SOHONOS palovarotene 10 mg Capsule, 14-count

by Ipsen Biopharmaceuticals, Inc. · 1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK
NDC 15054-0100-01
🏷️ FDA NDC (as labeled) 15054-0100-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 15054-0100-1
Product NDC 15054-0100
11-digit billing NDC 15054010001
NCPDP billing unit EA — each (per item)
RxCUI 2663960, 2663966, 2663968, 2663970, 2663972, 2663974, 2663976, 2663978,
UNII 28K6I5M16G
Application # NDA215559
SPL Set ID 67dce406-7cc4-4d66-92de-ad18b6df0625
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-16
Route ORAL
Dosage form CAPSULE
Substance PALOVAROTENE
GCN Seq No 085018
GCN 54454
HICL code 049043
Ingredient (HICL) Palovarotene
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z13
Therapeutic class — specific (HIC3) Retinoic Acid Receptor (Rar) Agonists
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name SOHONOS 10 MG CAPSULE
FDB brand name Sohonos
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 15054-0100-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 15054-0100-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Other drugs for disorders of the musculo-skeletal system
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerIpsen Biopharmaceuticals, Inc.
Application holderIPSEN BIOPHARMACEUTICALS INC
FDA applicationNDA215559 (NDA)
Labeler code15054
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio17 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SOHONOS 10 MG CAPSULE Ingredient Palovarotene
📖 What it is MedlinePlus · NLM

Palovarotene is used to reduce the number of new heterotrophic ossification (bony formations in muscle and soft tissue) in patients with fibrodysplasia ossificans progressive (FOP) in females aged 8 years or older or females aged 10 years or older. Palovarotene is in a class of medications called retinoids. It works by stopping the signaling responsible for heterotophic ossification.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, Sohonos doesn't break down bone that has already formed. What it does is help reduce how much new abnormal bone grows, especially during and after flare-ups — those painful epi...
  • What exactly does Sohonos do — will it dissolve the bone that's already formed?
  • Skin and lip dryness are by far the most common — almost everyone who takes Sohonos experiences some degree of dry skin, chapped lips, or itching. Hair thinning, rash, and dry eyes...
  • What are the side effects I'm most likely to notice?
📖 Read our full Palovarotene guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeCapsule
ImprintPVO;10
Size23 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3,495.36 $48,934.99 / 14 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sohonos 10 mgthis 15054-0100-01 Ipsen 14 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
First FDA approval
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 16, 2023 RLD RS ⏳ ~10.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11622959 — method of use (U-3676)
US 11622959 — method of use (U-3676)
US 11622959 — method of use (U-3676)
US 11622959 — method of use (U-3676)
US 11622959 — method of use (U-3676)
US 10864194 — method of use (U-3676)
US 10864194 — method of use (U-3676)
US 10864194 — method of use (U-3676)
US 10864194 — method of use (U-3676)
US 10864194 — method of use (U-3676)
US 10292954 — method of use (U-3676)
US 10292954 — method of use (U-3676)
US 10292954 — method of use (U-3676)
US 10292954 — method of use (U-3676)
US 10292954 — method of use (U-3676)
US 9789074 — method of use (U-3676)
US 9789074 — method of use (U-3676)
US 9789074 — method of use (U-3676)
US 9789074 — method of use (U-3676)
US 9789074 — method of use (U-3676)
US 9314439 — method of use (U-3676)
US 9314439 — method of use (U-3676)
US 9314439 — method of use (U-3676)
US 9314439 — method of use (U-3676)
US 9314439 — method of use (U-3676)
US 12023312 — method of use (U-3966)
US 12023312 — method of use (U-3966)
US 12023312 — method of use (U-3966)
US 12023312 — method of use (U-3966)
US 12023312 — method of use (U-3966)
US 12458626 — method of use (U-3676)
US 12458626 — method of use (U-3676)
US 12458626 — method of use (U-3676)
US 12458626 — method of use (U-3676)
US 12458626 — method of use (U-3676)
US 12138245 — method of use (U-4031)
US 12138245 — method of use (U-4031)
US 12138245 — method of use (U-4031)
US 12138245 — method of use (U-4031)
US 12138245 — method of use (U-4031)
US 12201614 — method of use (U-4031)
US 12201614 — method of use (U-4031)
US 12201614 — method of use (U-4031)
US 12201614 — method of use (U-4031)
US 12201614 — method of use (U-4031)
Exclusivity NCE
Exclusivity ODE-439
Exclusivity NCE
Exclusivity ODE-439
Exclusivity NCE
Exclusivity ODE-439
Exclusivity NCE
Exclusivity ODE-439
Exclusivity NCE
Exclusivity ODE-439
2023 2025 2027 2029 2031 2033 2035 2037
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (45)
PatentTypeUse codeExpires
US 11622959 ↗ Method of use U-3676 Jun 8, 2037
US 11622959 ↗ Method of use U-3676 Jun 8, 2037
US 11622959 ↗ Method of use U-3676 Jun 8, 2037
US 11622959 ↗ Method of use U-3676 Jun 8, 2037
US 11622959 ↗ Method of use U-3676 Jun 8, 2037
US 10864194 ↗ Method of use U-3676 Jun 8, 2037
US 10864194 ↗ Method of use U-3676 Jun 8, 2037
US 10864194 ↗ Method of use U-3676 Jun 8, 2037
US 10864194 ↗ Method of use U-3676 Jun 8, 2037
US 10864194 ↗ Method of use U-3676 Jun 8, 2037
US 10292954 ↗ Method of use U-3676 Aug 31, 2031
US 10292954 ↗ Method of use U-3676 Aug 31, 2031
US 10292954 ↗ Method of use U-3676 Aug 31, 2031
US 10292954 ↗ Method of use U-3676 Aug 31, 2031
US 10292954 ↗ Method of use U-3676 Aug 31, 2031
US 9789074 ↗ Method of use U-3676 Aug 31, 2031
US 9789074 ↗ Method of use U-3676 Aug 31, 2031
US 9789074 ↗ Method of use U-3676 Aug 31, 2031
US 9789074 ↗ Method of use U-3676 Aug 31, 2031
US 9789074 ↗ Method of use U-3676 Aug 31, 2031
US 9314439 ↗ Method of use U-3676 Aug 31, 2031
US 9314439 ↗ Method of use U-3676 Aug 31, 2031
US 9314439 ↗ Method of use U-3676 Aug 31, 2031
US 9314439 ↗ Method of use U-3676 Aug 31, 2031
US 9314439 ↗ Method of use U-3676 Aug 31, 2031
US 12023312 ↗ Method of use U-3966 Aug 31, 2031
US 12023312 ↗ Method of use U-3966 Aug 31, 2031
US 12023312 ↗ Method of use U-3966 Aug 31, 2031
US 12023312 ↗ Method of use U-3966 Aug 31, 2031
US 12023312 ↗ Method of use U-3966 Aug 31, 2031
US 12458626 ↗ Method of use U-3676 Jun 8, 2037
US 12458626 ↗ Method of use U-3676 Jun 8, 2037
US 12458626 ↗ Method of use U-3676 Jun 8, 2037
US 12458626 ↗ Method of use U-3676 Jun 8, 2037
US 12458626 ↗ Method of use U-3676 Jun 8, 2037
US 12138245 ↗ Method of use U-4031 Jun 8, 2037
US 12138245 ↗ Method of use U-4031 Jun 8, 2037
US 12138245 ↗ Method of use U-4031 Jun 8, 2037
US 12138245 ↗ Method of use U-4031 Jun 8, 2037
US 12138245 ↗ Method of use U-4031 Jun 8, 2037
US 12201614 ↗ Method of use U-4031 Jun 8, 2037
US 12201614 ↗ Method of use U-4031 Jun 8, 2037
US 12201614 ↗ Method of use U-4031 Jun 8, 2037
US 12201614 ↗ Method of use U-4031 Jun 8, 2037
US 12201614 ↗ Method of use U-4031 Jun 8, 2037
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Aug 16, 2028
ODE-439Orphan Drug Exclusivity (7-year)Aug 16, 2030
NCENew Chemical Entity (5-year)Aug 16, 2028
ODE-439Orphan Drug Exclusivity (7-year)Aug 16, 2030
NCENew Chemical Entity (5-year)Aug 16, 2028
ODE-439Orphan Drug Exclusivity (7-year)Aug 16, 2030
NCENew Chemical Entity (5-year)Aug 16, 2028
ODE-439Orphan Drug Exclusivity (7-year)Aug 16, 2030
NCENew Chemical Entity (5-year)Aug 16, 2028
ODE-439Orphan Drug Exclusivity (7-year)Aug 16, 2030
Common questions
Is there a generic version of SOHONOS 10 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SOHONOS 10 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2037 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sohonos — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sohonos. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.04M
Claims incl. refills
18
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$113,287.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SOHONOS (this brand).

Top reported reactions

Condition Aggravated29
Dry Skin13
Pruritus10
Skin Exfoliation9
Alopecia5
Cross Sensitivity Reaction4
Rash4

Age at onset

Child9
Adolescent6
Adult16

Reporter sex

57 reports
Male · 36%
Female · 64%

Serious outcomes

Disabling4
Death2
Reports over time (by year) — tap or hover for the count & year
2025 2026 12 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
15054-0100-01 You're viewing this 1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK 2023-08-16 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 15054-0100-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 15054-0100-01, written without dashes as 15054010001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 15054-0100-01, the first segment (15054) is the labeler code FDA assigned to Ipsen Biopharmaceuticals, Inc.; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ipsen Biopharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ipsen Biopharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 168 words ▾

WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. SOHONOS is contraindicated in pregnancy ( 5.1 , 8.1 ) Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met ( 5.1 , 8.1 ) SOHONOS causes premature epiphyseal closure in growing pediatric patients with FOP, close monitoring is recommended ( 5.2 , 8.4 ) Embryo-Fetal Toxicity SOHONOS is contraindicated in pregnancy.

SOHONOS may cause fetal harm. Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Premature Epiphyseal Closure Premature epiphyseal closure occurs in growing pediatric patients treated with SOHONOS, close monitoring is recommended [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ] .

🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is a retinoid indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP) ( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test in females of reproductive potential before initiation of SOHONOS ( 2.1 ) Recommended dosage includes a chronic daily dose, which can be increased for flare-up symptoms ( 2.2 ) For adults and pediatric patients 14 years and older: Recommended dosage is 5 mg once daily, with an increase in dose at the time of a flare-up to 20 mg once daily for 4 weeks, followed by 10 mg once daily for 8 weeks for a total of 12 weeks (20/10 mg flare-up treatment) ( 2.2 ) For pediatric patients under 14 years: Weight-adjusted for daily and flare-up dosing.

Recommended daily dosage range from 2.5 to 5 mg. Refer to Table 1 in Full Prescribing Information for complete pediatric dosing ( 2.2 ) Take SOHONOS with food preferably at same time each day ( 2.3 ). Reduce the dose in the event of adverse reactions as appropriate ( 2.4 ) See Full Prescribing Information for complete dosing instructions ( 2 )

2.1Pregnancy Testing Prior to Treatment with SOHONOS For females of reproductive potential, obtain a negative pregnancy test within one week prior to initiating and periodically during SOHONOS therapy . If pregnancy occurs, stop SOHONOS treatment immediately and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity. [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ].

2.2Recommended Dosage and Duration Dosage Overview Take SOHONOS with food preferably at the same time each day [see Dosage and Administration (2.3) ] . The recommended dosing for SOHONOS includes a chronic daily dosage (daily dose) which can then be modified/increased in the event of FOP flare-up symptoms (flare-up dose). Initiate flare-up treatment at the onset of the first symptom indicative of a FOP flare-up or substantial high-risk traumatic event likely to lead to a flare-up (e.g., surgery, intramuscular immunization, mandibular blocks for dental procedures, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses).

Symptoms of a FOP flare-up typically include but are not limited to localized pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness. Recommended Dosage for Adults and Pediatric Patients 14 Years and Older Daily Dose: The recommended SOHONOS daily dosage for adults and pediatric patients 14 years and older is 5 mg daily. Stop daily dosing when flare-up dosing begins.

Flare-up Dose: The recommended SOHONOS flare-up dosage for adults and pediatric patients 14 years and older is 20 mg daily for 4 weeks, followed by 10 mg daily for 8 weeks (for a total of 12 weeks of flare-up treatment), even if symptoms resolve earlier, then return to daily dosing of 5 mg. If during the course of flare-up treatment, the patient experiences marked worsening of the original flare-up site or another flare-up at a new location, restart the 12-week flare-up dosing at 20 mg daily. For flare-up symptoms that have not resolved at the end of the 12-week period, the 10 mg daily dosage may be extended in 4-week intervals and continued until the flare-up symptoms resolve.

If new flare-up symptoms occur after the 5 mg daily dosing is resumed, flare-up dosing may be restarted. Recommended Dosage for Pediatric Patients Aged 8 to 13 Years for Females and Aged 10 to 13 Years for Males Daily Dose: The recommended SOHONOS daily dosage for patients under 14 years of age is weight-based ranging from 2.5 mg to 5 mg daily (see Table 1 ). Stop daily dosing when flare-up dosing begins.

Flare-up Dose: The recommended flare-up SOHONOS dosage for patients under 14 years of age is weight-based (see Table 1 ). Administer the initial flare-up dosage once daily for 4 weeks, then administer the lower flare-up dosage once daily for 8 weeks (for a total of 12 weeks of flare-up treatment), even if symptoms resolve earlier, then return to daily dosing (see Table 1 ). If during the course of flare-up treatment, the patient…

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS SOHONOS is available in 4 strengths as an opaque white elongated size "0" hard-gelatin capsule, containing white to off-white powder. Table 4 shows capsules' strengths and imprints. Table 4. SOHONOS Capsules' Strengths and Imprints Strength (mg) Imprint 1 PVO 1

1.5PVO 1.5 5 PVO 5 10 PVO 10 Capsules: 1, 1.5, 5, 10 mg ( 3 )

⛔ Contraindications 73 words ▾

4 CONTRAINDICATIONS SOHONOS is contraindicated in the following patients: During Pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . A history of allergy or hypersensitivity to retinoids, or to any component of SOHONOS. Anaphylaxis and other allergic reactions have occurred with other retinoids. [see Description (11) ]. Pregnancy ( 4 , 5.1 , 8.1 ) Hypersensitivity to retinoids or any component of SOHONOS ( 4 , 11 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Premature Epiphyseal Closure: Premature epiphyseal closure occurred with SOHONOS. Assess baseline skeletal maturity before SOHONOS therapy and monitor linear growth in growing pediatric patients ( 5.2 ) Mucocutaneous Adverse Reactions: Dry skin, lip dry, pruritus, rash, alopecia, erythema, skin exfoliation, and dry eye occurred with SOHONOS. Prevent or treat with skin emollients, sunscreen, artificial tears.

Dosage reduction may be required in some patients ( 2.4 , 5.3 ) Metabolic Bone Disorders: Decreased vertebral bone mineral content and bone density may occur. Assess for spinal fracture periodically using radiologic method ( 5.4 ) Psychiatric Disorders: Depression, anxiety, mood alterations and suicidal thoughts and behaviors occurred with SOHONOS. Contact healthcare provider if new or worsening symptoms develop in patients treated with SOHONOS ( 5.5 ) Night Blindness: May occur and make driving at night hazardous ( 5.6 )

5.1Embryo-Fetal Toxicity SOHONOS can cause fetal harm and is contraindicated during pregnancy. SOHONOS is a member of the retinoid class of drugs which is associated with birth defects in humans. In animal reproduction studies, palovarotene administered orally to pregnant rats during organogenesis was teratogenic and caused fetal malformations typical of retinoids including cleft palate, misshapen skull bones, and shortening of the long bones at clinically relevant exposures.

For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment, periodically during the course of therapy and one month after treatment discontinuation. Advise females of reproductive potential to use an effective method of contraception at least one month prior to treatment, during treatment with SOHONOS and for 1 month after the last dose [see Use in Specific Populations (8.1 , 8.3) and Clinical Pharmacology (12.3) ]. If a pregnancy occurs during SOHONOS treatment, discontinue treatment immediately and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Patients should be informed not to donate blood during SOHONOS therapy and for 1 week following discontinuation because the blood might be given to a pregnant patient whose fetus must not be exposed to palovarotene.

5.2Premature Epiphyseal Closure in Growing Pediatric Patients SOHONOS can cause irreversible premature epiphyseal closure and potential adverse effects on growth. In clinical studies, premature epiphyseal closure occurred with SOHONOS treatment in growing pediatric patients with FOP [see Adverse Reactions (6.1) and Use in Specific Populations (8.4) ] . Monitoring of linear growth is recommended in growing pediatric patients [see Use in Specific Populations (8.4) ] .

Prior to starting treatment with SOHONOS, all growing pediatric patients should undergo baseline assessment of skeletal maturity via hand/wrist and knee x-rays, standard growth curves and pubertal staging. Continued monitoring is recommended every 6 to 12 months until patients reach skeletal maturity or final adult height. If a patient exhibits signs of premature epiphyseal closure or adverse effects on growth based on clinical or radiologic evaluations, further evaluation may be required, including an assessment of the benefits and risks of continued treatment, or temporary or permanent discontinuation of SOHONOS until the patient achieves epiphyseal closure and skeletal maturity.

5.3Mucocutaneous Adverse Reactions Mucocutaneous adverse reactions including dry skin, lip dry, pruritus, rash, alopecia, erythema, skin exfoliation [skin peeling], and dry eye occurred in most (98%) patients treated with SOHONOS. SOHONOS may contribute to an increased risk of skin and soft tissue infections, particularly paronychia and decubitus ulcer, due to a decreased skin barrier from adverse reactions such as dry and peeling skin [see Adverse Reactions (6.1) ] . Some of these mu…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Premature Epiphyseal Closure in Growing Pediatric Patients [see Warnings and Precautions (5.2) ] Mucocutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Metabolic Bone Disorders [see Warnings and Precautions (5.4) ] Psychiatric Disorders [see Warnings and Precautions (5.5) ] Night Blindness [see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence ≥10%) are dry skin, lip dry, arthralgia, pruritus, pain in extremity, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IPSEN Biopharmaceuticals, Inc at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SOHONOS was evaluated in clinical studies that enrolled a total of 164 subjects with FOP, including 139 subjects in the indicated population of ages 8 years and above for females and 10 years and above for males (8/10 years and older).

Most of these subjects received open label treatment with the chronic daily/flare-up regimen, consisting of 5 mg daily dosage of oral SOHONOS with a 20/10 mg dosage as needed for 12 weeks at the time of flare-up (4 weeks of 20 mg once daily followed by 10 mg once daily for 8 weeks), with all doses reduced by weight in subjects who were less than 90% skeletally mature. The mean duration of exposure was 79 weeks for chronic dosing (N=131 subjects) and 35 weeks for flare-up dosing (N=105 subjects). The mean age of these subjects was 19 years (range 8 to 61 years); 51% were male.

Serious adverse reactions occurred in 21 (15%) SOHONOS treated subjects in the 8/10 years or older population with the most common serious adverse reaction being premature epiphyseal closure. Adverse reactions leading to permanent discontinuation occurred in 11 (8%) SOHONOS treated subjects with dry skin being the most common in 2 (1%) subjects. Mucocutaneous adverse reactions leading to dose reductions were more common during SOHONOS 20/10 mg flare-up treatment (37%) than during chronic treatment (4%).

Table 5 below presents adverse reactions which occurred in at least 10% of FOP subjects 8/10 years and older during treatment with chronic or flare-up dosing. Table 5. Summary of Adverse Reactions Reported at greater than 10% Frequency in FOP Subjects 8/10 years and older in Clinical Trials Adverse Reaction Chronic 5 mg N=131 n (%) Flare-up dosing 20/10 mg N=105 n (%) Doses were reduced according to body weight in subjects who were less than 90% skeletally mature Dry skin 80 (61) 60 (57) Lip dry includes lip dry, chapped lips, cheilitis 62 (47) 40 (38) Arthralgia 47 (36) 32 (31) Pruritus includes pruritus, pruritus generalized, and rash pruritic 45 (34) 50 (48) Pain in extremity 38 (29) 29 (28) Rash includes rash, rash generalized, rash maculo-papular 36 (28) 31 (30) Alopecia 32 (24) 31 (30) Erythema includes erythema, generalized erythema, flushing, rash erythematous 25 (19) 34 (32) Headache includes headache and migraine 25 (19) 20 (19) Back pain includes back pain, flank pain, sciatica 22 (17) 12 (11) Skin exfoliation [skin peeling] 20 (15) 30 (29) Nausea 20 (15) 14 (13) Musculoskeletal pain 18 (14) 14 (13) Myalgia includes myalgia, musculoskeletal discomfort 15 (12) 9 (9) Dry eye 13 (10) 23 (22) Hypersensitivity includes drug eruption, hypersensitivity, pruritus allergic, drug hypersensitivity 13 (10) 21 (20) Peripheral edema includes peripheral swelling, edema peripheral 12 (9) 20 (19) Fatigue includes fatigue, lethargy, asthenia, malaise 7 (5) 12 (…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CYP3A4 Inhibitors: May increase SOHONOS exposure. Avoid concomitant use of strong/moderate CYP3A4 inhibitors. If concomitant use of moderate CYP3A4 inhibitors is unavoidable, reduce the dose of SOHONOS by half ( 2.5 , 7.1 ) CYP3A4 Inducers: May decrease SOHONOS exposure.

Avoid concomitant use of strong/moderate CYP3A4 inducers ( 7.1 ) Vitamin A: May cause additive effects ( 7.2 ) Tetracyclines: Avoid concomitant use with SOHONOS ( 7.3 ) Systemic Corticosteroids: No clinically significant drug interaction is expected with concomitant use of SOHONOS ( 7.4 )

7.1Effect of Other Drugs on SOHONOS Clinically significant drug interactions affecting the exposure of SOHONOS are listed in Table 6. Table 6. Drugs that affect exposure of SOHONOS.

Strong CYP3A Inhibitors Clinical Impact Co-administration of SOHONOS with strong CYP3A4 inhibitors increased the exposures of palovarotene [see Clinical Pharmacology (12.3) ] , which may increase the risk of SOHONOS adverse reactions. Prevention or Management Avoid concomitant use of a strong CYP3A4 inhibitor during SOHONOS treatment [see Dosage and Administration (2.5) ] . Moderate CYP3A Inhibitors Clinical Impact Co-administration of SOHONOS with moderate CYP3A4 inhibitors may increase the exposure of palovarotene [see Clinical Pharmacology (12.3) ] , which may increase the risk of SOHONOS adverse reactions.

Prevention or Management Avoid concomitant use of a moderate CYP3A4 inhibitor with SOHONOS, if possible. If co-administration will occur, reduce the SOHONOS dose by half when co-administered with moderate CYP3A inhibitors [see Dosage and Administration (2.5) ] . Strong CYP3A Inducers Clinical Impact Co-administration of SOHONOS with strong CYP3A4 inducers decreased the exposure of palovarotene [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of SOHONOS.

Prevention or Management Avoid concomitant use of strong CYP3A4 inducers with SOHONOS. [see Dosage and Administration (2.5) ] . Moderate CYP3A Inducers Clinical Impact Co-administration of moderate CYP3A4 inducers with palovarotene may decrease palovarotene exposure [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of SOHONOS. Prevention or Management Avoid concomitant use of moderate CYP3A4 inducers with SOHONOS.

7.2Vitamin A Palovarotene belongs to the same pharmacological class as vitamin A. Therefore, the use of both vitamin A and SOHONOS at the same time may lead to additive effects. Concomitant administration of vitamin A in doses higher than the recommended daily allowance (RDA) and/or other oral retinoids with SOHONOS must be avoided because of the risk of hypervitaminosis A.

7.3Tetracyclines Systemic retinoid use has been associated with cases of benign intracranial hypertension (also called pseudotumor cerebri), some of which involved the concomitant use of tetracyclines. Avoid coadministration of SOHONOS with tetracycline derivatives [see Adverse Reactions (6.1) ] .

7.4Systemic Corticosteroids No clinically significant drug-drug interaction is expected when SOHONOS is co-administered with prednisone [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm ( 2.1 , 4 , 8.1 ) Growing pediatric patients are recommended to undergo baseline assessment of growth and skeletal maturity before starting treatment and continued clinical and radiographic monitoring every 6 to 12 months until patients reach skeletal maturity or final adult height ( 5.2 , 8.4 )

8.1Pregnancy Risk Summary SOHONOS is contraindicated during pregnancy. Based on the findings in animal studies and class effects of retinoids, SOHONOS can cause fetal harm when administered during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . In animal reproduction studies, oral administration of palovarotene to pregnant rats during the period of organogenesis resulted in multiple fetal malformations typical of retinoids (e.g., cleft palate, malformed skull bone, shortening of the long bones) at doses ≥0.25 mg/kg/day (less than the clinical exposure) (see Data ) .

There are no available human data on SOHONOS use in pregnant women. If pregnancy occurs during treatment with SOHONOS, discontinue treatment immediately and refer the patient to an obstetrician/gynecologist or other specialist experienced in reproductive toxicity for further evaluation and counseling. Data Animal Data Palovarotene oral administration to pregnant rats during the period of organogenesis (gestation day 6 to 17) at doses of 0.01, 0.25 and 1.25 mg/kg/day resulted in fetal malformations consistent with retinoid-mediated embryopathy.

Palovarotene exposure resulted in fetal external, visceral and skeletal malformations typical of retinoids, including defects in the mouth (cleft palate, protruding tongue), eye (anophthalmia, microphthalmia), skull (dilated cerebral ventricle, misshapen brain), skeleton (shortening of the long bones), blood vessels, kidney, and ureters at doses ≥ 0.25 mg/kg/day (less than the clinical exposure). The fetal toxicity was observed at maternal rat exposures well below the range of clinically relevant exposures.

8.2Lactation Risk Summary There are no data available on the presence of palovarotene or its main metabolites in either animal or human milk, the effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants exposed to palovarotene through breastmilk, advise females that breastfeeding is not recommended during treatment with SOHONOS, and for at least 1 month after the final dose of SOHONOS.

8.3Females and Males of Reproductive Potential SOHONOS can cause fetal harm when administered during pregnancy [see Use in Specific Populations (8.1) ] Pregnancy Testing Obtain a negative serum pregnancy test within one week prior to SOHONOS therapy . Verify that patient is not pregnant periodically, as needed, over the course of treatment with SOHONOS and one month after treatment discontinuation unless they are not at risk of pregnancy. Contraception Females SOHONOS can cause embryo-fetal harm when administered during pregnancy [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ].

Advise females of reproductive potential to use effective contraception at least one month prior to treatment, during treatment with SOHONOS and for 1 month after the last dose, unless continuous abstinence is chosen. Males Palovarotene is present in semen (0.7 ng/mL) in amounts 100-fold lower than the maternal plasma exposure at the no observed adverse effect level (NOAEL) for fetal toxicity observed in animal studies. Administration of SOHONOS to a male patient is considered unlikely to affect development of an embryo or fetus carried by a pregnant female sexual partner exposed to SOHONOS via the patient's semen.

8.4Pediatric Use The safety and effectiveness of SOHONOS for the treatment of FOP have been established in pediatric patients aged 8 years and older for females and 10 years and older for males. Use of SOHONOS for this indication is supported by evidence from cli…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary SOHONOS is contraindicated during pregnancy. Based on the findings in animal studies and class effects of retinoids, SOHONOS can cause fetal harm when administered during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . In animal reproduction studies, oral administration of palovarotene to pregnant rats during the period of organogenesis resulted in multiple fetal malformations typical of retinoids (e.g., cleft palate, malformed skull bone, shortening of the long bones) at doses ≥0.25 mg/kg/day (less than the clinical exposure) (see Data ) .

There are no available human data on SOHONOS use in pregnant women. If pregnancy occurs during treatment with SOHONOS, discontinue treatment immediately and refer the patient to an obstetrician/gynecologist or other specialist experienced in reproductive toxicity for further evaluation and counseling. Data Animal Data Palovarotene oral administration to pregnant rats during the period of organogenesis (gestation day 6 to 17) at doses of 0.01, 0.25 and 1.25 mg/kg/day resulted in fetal malformations consistent with retinoid-mediated embryopathy.

Palovarotene exposure resulted in fetal external, visceral and skeletal malformations typical of retinoids, including defects in the mouth (cleft palate, protruding tongue), eye (anophthalmia, microphthalmia), skull (dilated cerebral ventricle, misshapen brain), skeleton (shortening of the long bones), blood vessels, kidney, and ureters at doses ≥ 0.25 mg/kg/day (less than the clinical exposure). The fetal toxicity was observed at maternal rat exposures well below the range of clinically relevant exposures.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of SOHONOS for the treatment of FOP have been established in pediatric patients aged 8 years and older for females and 10 years and older for males. Use of SOHONOS for this indication is supported by evidence from clinical studies in adults and pediatric subjects [see Clinical Studies (14) ] . The safety and effectiveness of SOHONOS for the treatment of FOP have not been established in pediatric patients less than 8 years of age in females and less than 10 years of age for males.

SOHONOS is not recommended for use in patients younger than 8 years of age for females and 10 years of age for males because of the potential for premature epiphyseal closure. Clinical studies have shown that growing patients with open epiphyses are at risk of developing premature epiphyseal closure when treated with SOHONOS [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) and Clinical Studies (14.1) ] . Bone Safety In clinical studies with SOHONOS, assessments of growth and bone safety in growing children included linear and knee height, femur and tibia length measured by Whole-Body Computed Tomography (WBCT), and hand/wrist and knee radiographs.

Premature epiphyseal closure has been identified as an irreversible serious risk associated with SOHONOS treatment. Premature epiphyseal closure was observed as early as 6 months after initiating therapy with the majority occurring at or after 12 months. In SOHONOS treated subjects there was a trend of declining height Z-scores in adolescent subjects, potentially due to a loss of linear height and/or increasing spinal deformity.

The long-term effects on final height in subjects with FOP treated with SOHONOS have not been established. [see Adverse Reactions (6.1) ] . Monitoring Recommendation Prior to starting treatment with SOHONOS, all growing children should undergo baseline clinical and radiological assessments including but not limited to an assessment of skeletal maturity via hand/wrist and knee x-rays, standard growth curves and pubertal staging. Continued monitoring is recommended every 6-12 months until patients reach skeletal maturity (e.g., epiphyseal closure) or final adult height [see Warnings and Precautions (5.2) ] .

Juvenile Animal Data A juvenile animal study was conducted in juvenile rats given daily oral doses of palovarotene at 0.1, 0.5 or 1.2 mg/kg/day from Week 3 to Week 9 of age (prior to epiphyseal fusion). Palovarotene adversely affected skeletal growth and development including, reduction in bone size, abnormal bone shape and/or geometry, diffuse bone loss, and growth in general were affected at ≥ 0.5 mg/kg/day (less than the clinical exposure). As expected, physes were either widened due to an expanded zone of cartilage hypertrophy/maturation (sometimes accompanied by chondrodysplasia), narrowed, or partially/completely closed.

In the proximal femur, avascular necrosis of the femoral head was observed accompanied with malformations and microfractures of trabeculae in a few rats at 1.2 mg/kg/day (less than the clinical exposure). In vertebrae, palovarotene completely inhibited the endochondral ossification that normally occurs in the hyaline cartilage at the end of the vertebral body There also were tibial fractures in two high-dose females. The skeletal effects showed evidence of reversing after dosing discontinuation at 0.5 mg/kg/day, but not at highest dose of 1.2 mg/kg/day.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Clinical studies of SOHONOS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 59 words ▾

10 OVERDOSAGE No clinical experience with an overdose of SOHONOS has been reported. SOHONOS is a derivative of vitamin A. In case of accidental overdose, signs of hypervitaminosis A could appear, including severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Any overdose should be treated with supportive care according to the signs and symptoms exhibited by the patient.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In patients with FOP, abnormal bone formation, including heterotopic ossification (HO), is driven by a gain-of-function mutation in the bone morphogenetic protein (BMP) type I receptor ALK2 (ACVR1). Palovarotene is an orally bioavailable retinoic acid receptor agonist, with particular selectivity at the gamma subtype of RAR. Through binding to RARγ, palovarotene decreases the BMP/ALK2 downstream signaling pathway by inhibiting the phosphorylation of SMAD1/5/8, which reduces ALK2/SMAD-dependent chondrogenesis and osteocyte differentiation resulting in reduced endochondral bone formation.

12.2Pharmacodynamics Cardiac Electrophysiology At doses up to 2.5 times the maximum recommended dose, palovarotene does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Palovarotene exposure (AUC) increases proportionally from 0.02 to 50 mg (0.001 to 2.5 times the maximum recommended dosage). Steady-state is achieved by Day 3 following once daily dosing. Palovarotene exposure in patients with FOP are listed in Table 7.

Table 7. Palovarotene Exposures in Patients with FOP Palovarotene Dosage C max,ss (ng/mL) AUC 0-t (ng*h/mL) Accumulation Ratio Pharmacokinetics parameters are presented as mean (± SD). Chronic dose 5 mg or weight-based equivalent 40.6 (± 16.2) 264 (± 98.4)

1.16Flare-up dose 10 mg or weight-based equivalent 78.4 (± 33.3) 540 (± 226)

1.14Flare-up dose 20 mg or weight-based equivalent 165 (± 72.7) 1060 (± 449)

1.04Absorption The median time to achieve peak concentration (T max ) of palovarotene was 3.0 to 4.0 hours across the chronic dose of 5 mg to flare-up dose of 10 and 20 mg. Effect of Food Palovarotene mean AUC and mean C max increased by approximately 40% and 16%, respectively; T max was delayed by approximately 2 hours with a high-fat, high-calorie meal (800 to 1000 calories, 15% protein, 25% carbohydrate, and 50 to 60% fat). No clinically significant differences in the AUC and C max of palovarotene were observed when palovarotene was administered whole compared to the contents sprinkled onto one teaspoon of applesauce following a high-fat, high-caloric breakfast.

Distribution The mean (SD) apparent volume of distribution (Vd/F) is 237 (± 90.1) L following administration of a single 20 mg dose with food. Protein binding of palovarotene is 97.9% to 99.6% in vitro. The mean blood-to-plasma ratio of palovarotene in humans is 0.62.

Elimination The mean elimination half-life is 8.7 hours following administration of a 20 mg once daily dosage for 14 days with a standard breakfast (800 to 1000 calories, 15% protein, 25% carbohydrate, and 50 to 60% fat). The apparent total body clearance (CL/F) of palovarotene is estimated at

19.9L/h. Metabolism Palovarotene is extensively metabolized by CYP3A4 and to a minor extent by CYP2C8 and CYP2C19. Following administration of [ 14 -C]-radiolabeled palovarotene, the contribution of palovarotene and its four known major metabolites (M2, M3, M4a, and M4b) represented collectively 40% of the total exposure in plasma.

The pharmacological activity of M3 and M4b is approximately 1.7% and 4.2% of the activity of the parent drug. Excretion Following administration of a 1 mg dose of [ 14 C]-radiolabeled palovarotene in healthy subjects, 97.1% of the dose was recovered in the feces and 3.2% in the urine. Specific Populations There were no clinically significant differences in the pharmacokinetics of palovarotene based on age (2 to 85 years old), sex, race (Asian, black, white and others), smoking status, mild to moderate renal impairment, or mild hepatic impairment.

The effect of severe renal impairment, or moderate to severe hepatic impairment on the pharmacokinetics of palovarotene is unknown. Body Weight Body weight (13 to 130 kg) was found to have a significant effect on the pharmacokinetics of palovarotene resulting in increasing exposure with decreasing weight at the same dose. Pediatric Patients The estimated…

🧬 Mechanism of Action 80 words ▾

12.1Mechanism of Action In patients with FOP, abnormal bone formation, including heterotopic ossification (HO), is driven by a gain-of-function mutation in the bone morphogenetic protein (BMP) type I receptor ALK2 (ACVR1). Palovarotene is an orally bioavailable retinoic acid receptor agonist, with particular selectivity at the gamma subtype of RAR. Through binding to RARγ, palovarotene decreases the BMP/ALK2 downstream signaling pathway by inhibiting the phosphorylation of SMAD1/5/8, which reduces ALK2/SMAD-dependent chondrogenesis and osteocyte differentiation resulting in reduced endochondral bone formation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SOHONOS is an opaque white elongated hard-gelatin capsule. SOHONOS is available in size "0" capsule and supplied as a blister strip containing 14 capsules in a child resistant carton. Capsule contains white to off-white powder. Table 8 shows capsules' strengths, imprints, and NDC numbers. Table 8. Capsules' Strengths, Imprints, and NDC numbers Strength (mg) Imprint NDC 1 PVO 1 15054-0010-1

1.5PVO 1.5 15054-0015-1 5 PVO 5 15054-0050-1 10 PVO 10 15054-0100-1 Storage and Handling This package is child-resistant. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room temperature].

SOHONOS must be kept in the original carton to protect from light. SOHONOS capsules may be opened and the contents emptied on a teaspoon of soft food and taken immediately. If not taken immediately, it can be taken after a maximum of one hour after the sprinkling, provided it was maintained at room temperature and not exposed to direct sunlight.

How Supplied SOHONOS is an opaque white elongated hard-gelatin capsule. SOHONOS is available in size "0" capsule and supplied as a blister strip containing 14 capsules in a child resistant carton. Capsule contains white to off-white powder. Table 8 shows capsules' strengths, imprints, and NDC numbers. Table 8. Capsules' Strengths, Imprints, and NDC numbers Strength (mg) Imprint NDC 1 PVO 1 15054-0010-1

1.5PVO 1.5 15054-0015-1 5 PVO 5 15054-0050-1 10 PVO 10 15054-0100-1

📦 Storage and Handling 95 words ▾

Storage and Handling This package is child-resistant. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room temperature].

SOHONOS must be kept in the original carton to protect from light. SOHONOS capsules may be opened and the contents emptied on a teaspoon of soft food and taken immediately. If not taken immediately, it can be taken after a maximum of one hour after the sprinkling, provided it was maintained at room temperature and not exposed to direct sunlight.

📋 Description 128 words ▾

11 DESCRIPTION Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[( E )-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C 27 H 30 N 2 O 2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below: SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths.

Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity : Advise patients that SOHONOS can cause fetal harm and is contraindicated during pregnancy. Advise patients to verify that they are not pregnant prior to initiating and periodically during SOHONOS treatment as well as one month after treatment discontinuation [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] .

Advise females of reproductive potential that they must avoid pregnancy while taking SOHONOS and for at least one month following discontinuation of therapy. Advise females of childbearing potential to use at least one highly effective method of contraception (i.e. IUD) or two effective methods (i.e. combined hormonal contraception in combination with another method of contraception such as a barrier method) during treatment with SOHONOS [see Use in Specific Populations (8.3) ] .

Instruct patients to immediately stop taking SOHONOS if she becomes pregnant while taking SOHONOS and to rapidly consult her healthcare provider if there is a risk of pregnancy or if she might be pregnant. Instruct patients to not donate blood during SOHONOS treatment and for 1 week following discontinuation to avoid blood donation to a pregnant patient and fetus. Lactation Because of the potential for serious adverse reactions from SOHONOS in a breastfed child, advise females not to breastfeed during treatment with SOHONOS, and for at least 1 month after the last dose of SOHONOS.

Premature Epiphyseal Closure : Inform patients that SOHONOS has been shown to cause premature epiphyseal closure in growing pediatric patients with FOP and discuss the proposed monitoring plan with the patient and caregiver [see Warnings and Precautions (5.2) ]. Mucocutaneous Adverse Reactions : Advise patients that they may experience dry skin, lip dry, pruritus, rash, alopecia, erythema, skin exfoliation, and dry eye. Discuss the plan to assess their symptoms and adjust the dose if needed [see Dosage and Administration (2.4) and Warning and Precautions (5.3) ] .

Recommend prophylactic measures to minimize risk and/or treat the mucocutaneous adverse reactions are recommended (e.g. skin emollients, sunscreen, lip moisturizers, artificial tears) [see Warnings and Precautions (5.3) ] . Photosensitivity : Advise patients of potential increased skin sensitivity to sunlight while taking SOHONOS and to minimize exposure to sunlight and artificial ultraviolet light [see Warnings and Precautions (5.3) ]. Radiological Vertebral Fractures : Inform patients that SOHONOS resulted in decreased vertebral bone mineral content, bone density and bone strength as well as an increased risk of radiologically observed vertebral fractures and that periodic radiological assessment of the spine is recommended [see Warnings and Precautions (5.4) ].

Psychiatric Disorders: Advise patients of the possibility of experiencing new or worsening psychiatric effects, including suicidal thoughts and behaviors, depression, depression aggravated, anxiety, and mood alterations. Particular care should be taken in patients with a history of psychiatric illness. Patients should be monitored for signs of depression and referred for appropriate treatment if necessary [see Warnings and Precautions (5.5) ] .

Night Blindness: Advise patients of the risk of experiencing night blindness [see Warnings and Precautions (5.6) ]. Drug Interactions : Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products [see Dosage and Administration (2.5) and Drug Interactions (7) ] . Dosing Instructions : Advise the patient to take SOHONOS capsules with food.

If the patient is unable to swallow the capsule, the capsule contents may be emptied onto soft food [see Dosage and Administration (2.3) ] . Missed dose: If a dose is mis…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 3/2025 MEDICATION GUIDE SOHONOS [so-ho-nos] (palovarotene) capsules, for oral use What is the most important information I should know about SOHONOS? SOHONOS can cause birth defects (deformed babies) if taken during pregnancy.

Females who are pregnant or who plan to become pregnant must not take SOHONOS. Females who can become pregnant: - Your healthcare provider will ask you to take a pregnancy test 1 week before starting treatment with SOHONOS, periodically during treatment, and 1 month after you stop treatment with SOHONOS. - You must use effective birth control (contraception) starting at least 1 month before starting treatment with SOHONOS, during treatment and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you. - If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your healthcare provider right away.

Because SOHONOS can cause birth defects, SOHONOS is only for people who can understand and agree to carry out all instructions for pregnancy prevention. SOHONOS can cause bone growth changes. Children may stop growing while taking SOHONOS.

Bone growth changes such as permanent early closure of the growth plate in growing children have happened with SOHONOS. Your healthcare provider will closely monitor your child's bone growth and height during treatment with SOHONOS. What is SOHONOS?

SOHONOS is a prescription medicine used to reduce the amount of new heterotopic ossification in adults and children 8 years of age and older for females and 10 years of age and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is not recommended for females younger than 8 years of age or males younger than 10 years of age. Do not take SOHONOS if you: are pregnant.

(See " What is the most important information I should know about SOHONOS? " ) are allergic to medicines known as retinoids or any of the ingredients in SOHONOS. See the end of this Medication Guide for a complete list of ingredients in SOHONOS. Before taking SOHONOS, tell your healthcare provider about all your medical conditions, including if you: have bone loss (osteoporosis), weak bones or any other bone problems. have or had mental health problems. have or have had kidney problems. have or have had liver problems. are breastfeeding or plan to breastfeed.

It is not known if SOHONOS passes into your breastmilk. Breastfeeding is not recommended during treatment with SOHONOS and for at least 1 month after the last dose of SOHONOS. Talk to your healthcare provider about the best way to feed your baby if you take SOHONOS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOHONOS and certain other medicines can interact with each other, sometimes causing serious side effects. Know the medicines you take.

Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How should I take SOHONOS? Take SOHONOS exactly as your healthcare provider tells you.

Take SOHONOS capsules whole with food. If you are unable to swallow the capsule, the capsule contents may be emptied onto a teaspoon (5 mL) of soft food (such as apple sauce, low-fat yogurt, or warm oatmeal) and taken within 1 hour of opening. Take SOHONOS at about the same time each day.

Do not eat grapefruit or drink grapefruit juice during treatment with SOHONOS. Grapefruit may increase the levels of SOHONOS in your blood. If you miss a dose of SOHONOS, take it as soon as you remember.

If the dose has been missed by more than 6 hours, the missed dose should be skipped, and next dose should be taken at the regular time. Do not take two doses at the same time or in the same day. Your healthcare provider may change your dose of SOHONOS as needed if you get certain…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.