Imcivree (Setmelanotide)

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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.

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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  • Product Details

    Description

    Imcivree, also known as Setmelanotide, is a medication used to treat obesity caused by certain rare genetic conditions. It works as a melanocortin 4 (MC4) receptor agonist, which means it activates receptors in the brain linked to appetite regulation. As a result, Imcivree may help reduce hunger and increase energy expenditure. It is approved for individuals, including adults and children over the age of 6, who have obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiencies, along with other specific genetic disorders related to obesity.

    Directions

    Imcivree is administered as a subcutaneous (under the skin) injection once daily. The recommended starting dosage for people 12 and older is 2 mg once daily for two weeks, while the recommended start dosage for people 6 to 12 is 1 mg once daily for two weeks. The usual target dosage is 3 mg once daily for individuals 6 years and older.

    People with mild to moderate kidney problems typically don't need to adjust their dose; however, for those with severe kidney problems, a medical professional may suggest a different starting dosage. Always follow medical advice from a healthcare provider and monitor as recommended when using this medication.

    Ingredients

    Imcivree contains the active ingredient Setmelanotide. Inactive ingredients may be included in the formulation of the medication and include benzyl alcohol, mannitol, phenol, and water for injection.

    Contraindications

    Avoid using this medication if you have a known allergy to Setmelanotide or any ingredient of the formulation.

    Cautions

    • Before using Imcivree, tell your doctor or healthcare provider about the following:
      • Any medical conditions you have.
      • Other medications you may be taking.
      • Whether you’re pregnant or breastfeeding.
    • Imcivree has been linked to disturbances in sexual arousal. Men may experience spontaneous erections, while females may have sexual adverse reactions. If you have an erection lasting longer than 4 hours, seek emergency medical attention.
    • Depression and suicidal thoughts have been reported with Imcivree use. If you notice new onset or worsening depression, or if you have suicidal thoughts or behaviors, inform your healthcare provider. Discontinuation of Imcivree should be considered if you experience severe or persistent depression symptoms or suicidal thoughts or behaviors.
    • Serious hypersensitivity reactions, like anaphylaxis, may occur with Imcivree. If you suspect a hypersensitivity reaction, with symptoms such as trouble breathing, hives, and swelling, seek medical attention immediately and stop taking Imcivree.
    • Imcivree may cause increased skin pigmentation and darkening of pre-existing moles. It's recommended that you have a full-body skin examination before starting Imcivree and periodically during treatment to monitor for new or changing skin lesions.
    • Imcivree is not approved for use in neonates or infants due to the risk of serious adverse reactions from the benzyl alcohol preservative, including “gasping syndrome” in neonates and low birth weight infants.

    Side Effects

    Imcivree may cause a range of side effects. Common Imcivree side effects may include nausea, vomiting, headache, diarrhea, stomach pain, and reactions at the injection site, such as bruising, swelling, and redness. These reactions are typically not severe and often resolve as the body adapts to the treatment. Hyperpigmentation, or darkening of the skin, is also commonly reported.

    In rarer cases, Imcivree can lead to more severe side effects that may need prompt medical attention. These include new or worsening depression, suicidal thoughts, and erections lasting more than four hours. Serious allergic reactions are also possible and may present as a rash, hives, or difficulty breathing. Discuss any concerns about adverse effects with a healthcare professional.

    References:

    1. Imcivree (Setmelanotide) Product Monograph. Boston, MA: Rhythm Pharmaceuticals; 2023.
    2. Imcivree (Setmelanotide) Drug Label Information. Boston, MA: Rhythm Pharmaceuticals; 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 : 14425

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