Palovarotene

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).

Prescribing label

Selected manufacturer label information, organised into consistent sections by Sofidex. This source is written for healthcare professionals; ask your pharmacist to explain instructions that are unclear. Read the full label at DailyMed ↗

Drug facts

Used for: 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).
Do not take if: During Pregnancy.
A history of allergy or hypersensitivity to retinoids, or to any component of SOHONOS. Anaphylaxis and other allergic reactions have occurred with other retinoids..

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

Premature Epiphyseal Closure in Growing Pediatric Patients
Mucocutaneous Adverse Reactions
Metabolic Bone Disorders
Psychiatric Disorders
Night Blindness

Who should not take it

SOHONOS is contraindicated in the following patients:

During Pregnancy.
A history of allergy or hypersensitivity to retinoids, or to any component of SOHONOS. Anaphylaxis and other allergic reactions have occurred with other retinoids..

Storing it

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). 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.

Cite this page

NLM: sofidex [Internet]. Daloreum; c2026. Palovarotene; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/palovarotene
APA 7th: sofidex. (2026, August 3). Palovarotene. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/palovarotene
AMA 11th: Palovarotene. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/palovarotene

The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.