Sohonos (Palovarotene)
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.
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Prescription Required
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Product Details
Description
Sohonos (Palovarotene) is a prescription drug used to treat fibrodysplasia ossificans progressiva (FOP), a rare and debilitating disorder. It works as a retinoic acid receptor (gamma) agonist, which means it activates specific cell-surface receptors that influence the growth and remodeling of bone tissue. As a result, this medication helps slow new heterotopic ossification, in which bone forms in soft tissue. It is typically prescribed for female adults and children 8 years and older and male adults and children 10 years and older.
Directions
Follow your healthcare provider's instructions carefully when taking Sohonos. The usual dosage depends on the age of the person taking the medication. It is taken as an oral capsule once daily with food at the same time each day. The dosage is typically increased during flare-ups. However, the dosage may be reduced if adverse effects occur while taking the medication.
Ingredients
The main ingredient in Sohonos is Palovarotene. Inactive ingredients may include lactose monohydrate, magnesium stearate, microcrystalline cellulose, and lauryl sulfate, among others.
Contraindications
Avoid taking or using Sohonos if any of the following apply:
- Pregnancy: Sohonos may cause fetal harm and is contraindicated during pregnancy due to the risk of harm.
- Allergy to Palovarotene: If there is a known allergy to Palovarotene or any ingredients of the Sohonos formulation, this medication should be avoided.
Cautions
- Consult your doctor or healthcare provider about any of the following before starting treatment with Sohonos:
- Other medical conditions, including mental health problems and kidney or liver issues.
- Whether you’re pregnant or breastfeeding.
- Any medications you take, including prescription and over-the-counter medicines.
- Sohonos is contraindicated in pregnancy due to the risk of harm to an unborn baby (teratogenicity). It should only be administered if strict measures for pregnancy prevention are in place.
- In growing children with FOP, Sohonos can cause premature epiphyseal closure, which may result in stunted growth. Regular monitoring of bone development is recommended.
- Skin and mucous membrane related side effects are possible, such as dry skin, chapped lips, itching, rashes, hair loss, skin redness, peeling skin, and dry eyes. Using moisturizers, sunscreen, and artificial tears may help alleviate these issues. If they become severe, your doctor might adjust your dose.
- Sohonos can affect your bone health, potentially leading to decreased bone mineral content and density. Periodic checks for spinal fractures using radiographic methods might be necessary.
- Pay attention to any changes in your mental health. Symptoms like depression, anxiety, mood changes, or suicidal thoughts or behaviors can occur with Sohonos. If you notice any new or worsening mental health symptoms, it's important to contact your healthcare provider immediately.
- Night blindness is a potential side effect of Sohonos, which could make driving at night hazardous.
Side Effects
Sohonos may trigger a range of side effects, affecting individuals in different ways. Some of the most common Sohonos side effects include dry skin, itching, joint pain, and chapped lips. It's not uncommon for those taking the medication to also experience muscle pain, nausea, and hair loss, among other side effects.
Sohonos may also cause more severe side effects that may require immediate attention from healthcare professionals. Serious side effects may include low bone mineral density and mental health changes, such as depression or anxiety. Some people could experience night blindness or significant change in vision. If skin problems such as excessive dryness, peeling, a rash, or redness develop, consult a healthcare provider promptly.
References:
- Sohonos (Palovarotene) Product Monograph. Cambridge, MA: Ipsen Biopharmaceuticals; 2023.
- Sohonos (Palovarotene) Drug Label Information. Cambridge, MA: Ipsen Biopharmaceuticals; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14427
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