Sohonos (Palovarotene)

Prescription medicineOnly Available By Prescription

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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.

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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.

Description

Sohonos (Palovarotene) is a medication used to manage a rare condition known as fibrodysplasia ossificans progressiva (FOP). It is classified as a retinoic acid receptor (gamma) agonist that targets certain cell receptors and reduces the formation of new bone in soft tissues. It's mainly prescribed to those who are eight years and older for females and ten years and older for males with FOP.

Directions

Sohonos is taken by mouth and should be used according to a doctor's prescription. The dosage varies based on factors like age and the development of a flare-up. However, the oral capsule is usually taken daily, with the dosage increasing if there are symptoms of a flare-up. The medication should be taken with food at the same time each day for maximum effectiveness.

Ingredients

Sohonos contains the active ingredient Palovarotene. The medication may also include inactive ingredients, such as magnesium stearate, lactose monohydrate, lauryl sulfate, and microcrystalline cellulose, among others.

Contraindications

Sohonos should not be used or taken if any of the following apply:

  • Pregnancy: The drug is contraindicated due to potential fetal harm.
  • Allergy to retinoids: As Sohonos belongs to the retinoid class, those with known allergies to retinoids may need to avoid using it.

Cautions

  • Before starting Sohonos, inform your healthcare provider about:
    • Any current medications.
    • Existing medical conditions, such as liver or kidney issues.
    • Pregnancy status or intentions to become pregnant, due to potential risks to the fetus
    • Breastfeeding, as Sohonos may be transferred to breast milk and affect the baby
  • Sohonos should not be used if you are pregnant or planning to become pregnant due to the risk of serious harm to the unborn baby. Use reliable contraception to prevent pregnancy while on Sohonos.
  • For growing children and adolescents with FOP, Sohonos may cause the growth plates in the bones to close prematurely. Regular monitoring of bone growth and development is essential.
  • You may experience mucocutaneous adverse reactions like dry skin, chapped lips, itching, rashes, hair loss, skin redness, peeling skin, and dry eyes. To manage these, you can use skin moisturizers, sunscreen, and artificial tears. If these side effects are severe, your dosage of Sohonos may need to be adjusted.
  • There's a risk of metabolic bone disorders, including a decrease in bone mineral content and density. It's important to have periodic spine evaluations to check for any fractures.
  • Be alert for signs of psychiatric disorders, such as depression, anxiety, mood alterations, or suicidal thoughts and behaviors. If you experience any of these symptoms, particularly if they are new or worsening, you should contact your healthcare provider immediately.
  • Night blindness is a potential side effect of Sohonos, which could affect your ability to see in low light or during the night and make activities like driving more dangerous.

Side Effects

Sohonos may cause a variety of side effects. The most common Sohonos side effects include redness of the skin, joint pain, dry skin, and itching. Some patients have also reported headaches, dry lips, and dry eyes. Others might notice a loss of hair or thinning, as well as symptoms like nausea and muscle pain.

While most side effects are manageable, Sohonos can also lead to more serious side effects. These side effects may include low bone mineral density or mental health challenges such as depression, anxiety, mood fluctuations, or even suicidal thoughts or actions. In addition, trouble with vision, including night blindness, could occur. If any severe side effects occur, contact a healthcare provider immediately.

References:

  1. Sohonos (Palovarotene) Product Monograph. Cambridge, MA: Ipsen Biopharmaceuticals; 2023.
  2. 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.

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