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Sohonos (Palovarotene)

Prescription requiredOnly Available By Prescription
What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.


Sohonos (Palovarotene) is a medication used for the treatment of Fibrodysplasia Ossificans Progressiva (FOP), a rare and debilitating genetic disorder characterized by the abnormal growth of bone in muscles, tendons, and other soft tissues. As an oral retinoid medication, Sohonos works by targeting specific pathways that regulate bone growth and development, helping to reduce the progression of heterotopic ossification, which is the hallmark of FOP.

This innovative treatment offers hope and improvement in the quality of life for patients suffering from this challenging condition. Sohonos is a result of years of research and dedication to understanding the molecular basis of FOP and represents a significant advancement in the therapeutic options available for managing this disease.

Fact Table
Generic Name Palovarotene
Brand Name Sohonos
Formula C27H30NO2
License FDA Approved
Bioavailability High
Legal Status Prescription Only
Elimination Half-Life 7-10 hours
Dosage (Strength) 5 mg or 20 mg capsules
Pregnancy Contraindicated; should not be used during pregnancy
Protein Binding Highly Protein-Bound
PubChem CID 9865958
DrugBank DB11876
Routes of Administration Oral

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Sohonos should be taken orally, once daily, with food.

The recommended dosage is based on the patient's weight and the specific recommendations of a healthcare provider.

It is crucial to follow the dosage prescribed by your healthcare provider, as the dosing regimen may be adjusted based on response to treatment and any side effects experienced.

Do not start taking Palovarotene capsules without the guidance of a healthcare provider who is experienced in treating FOP.

Stopping Sohonos abruptly can lead to a rebound effect or worsening of symptoms. Always consult your healthcare provider before discontinuing this medication.


Active Ingredient: Palovarotene.


Sohonos is not suitable for everyone. A thorough medical history and examination should be conducted by a healthcare provider before initiating treatment.

Regular monitoring, including blood tests and physical examinations, is essential to check for any adverse effects and to ensure the medication is working effectively.

Sohonos is classified under FDA Pregnancy Category X, indicating it can cause fetal harm when administered to a pregnant woman. Effective contraception must be used by women of reproductive potential while taking Sohonos and for some time after the last dose.

It is not known whether Palovarotene is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of the drug to the mother.

The safety and effectiveness of Sohonos in pediatric patients have not been fully established. Use in children should be considered carefully, with close monitoring.


Avoid using Sohonos concurrently with other retinoids, including isotretinoin and acitretin, due to the potential for additive toxic effects.

Caution should be exercised when combining Sohonos with vitamin A supplements, as excessive vitamin A can exacerbate the side effects of Palovarotene.

Side Effects

Common side effects of Sohonos include:

  • Dry skin and mucous membranes
  • Hair loss
  • Elevated cholesterol and triglycerides
  • Muscle and joint pain
  • Mild to moderate headache

Frequently Asked Questions about Sohonos (Palovarotene)

What is Sohonos used for?

Sohonos (palovarotene) is used to reduce the formation of heterotopic ossification (HO), which is the abnormal formation of bone in soft tissues, in patients with fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic disorder characterized by the progressive formation of bone outside the skeleton, which can lead to severe disability.

What class of drug is palovarotene?

Palovarotene is classified as a retinoic acid receptor gamma (RAR?) agonist. It is a type of retinoid, which is a class of drugs related to vitamin A that regulates growth, development, and differentiation of cells.

How does Sohonos work?

Sohonos works by activating the retinoic acid receptor gamma (RAR?), which plays a role in regulating bone formation and development. By activating this receptor, palovarotene can help to reduce the abnormal bone growth associated with fibrodysplasia ossificans progressiva (FOP). This helps in decreasing the formation of heterotopic ossification (HO) in affected individuals.

Is palovarotene FDA approved?

As of now, palovarotene (Sohonos) is not approved by the U.S. Food and Drug Administration (FDA). It has received regulatory approval in some other countries, but it is still under review by the FDA for the treatment of fibrodysplasia ossificans progressiva (FOP).

What is the indication of Sohonos?

Sohonos is indicated for the treatment of fibrodysplasia ossificans progressiva (FOP), specifically to reduce the formation of heterotopic ossification (HO) in affected individuals. This treatment aims to manage the symptoms and progression of this rare and disabling genetic condition.