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Myalept

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  • Product Details

    Description

    Myalept contains metreleptin, a recombinant analog of human leptin, a hormone primarily produced by adipose tissue. It is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. In these patients, leptin deficiency leads to metabolic abnormalities including insulin resistance, diabetes mellitus, hypertriglyceridemia, and hepatic steatosis. Myalept works by restoring physiological leptin levels, which helps improve metabolic control.

    F act Table

    Formula

    C636H1008N164O199S4

    License

    US FDA (2014)

    Bioavailability

    ~85% (subcutaneous)

    Legal status

    Prescription only (Rx); orphan drug designation

    Chemical Name

    Metreleptin (recombinant methionyl human leptin)

    Elimination half-life

    ~3.8–4.7 hours (subcutaneous)

    Dosage (Strength)

    Administered as lyophilized powder for reconstitution: 5 mg, 11.3 mg vials. Dose individualized (e.g., 0.06 to 0.13 mg/kg/day)

    Pregnancy

    Use only if clearly needed (Category C)

    Brands

    Myalept

    Protein binding

    Not extensively protein-bound

    PubChem CID

    16132452

    MedlinePlus

    a614046

    ChEBI

    85183

    ATC code

    A16AX07

    DrugBank

    DB09046

    KEGG

    D10335

    Routes of administration

    Subcutaneous (SC)

    Directions

    Myalept is administered once daily by subcutaneous injection. Dosing is weight-based and individualized:

    • For females =40 kg, the recommended starting dose is 5 mg daily; for males =40 kg, 2.5 mg daily.
    • For patients <40 kg, the starting dose is 0.06 mg/kg (females) or 0.04 mg/kg (males).Dose adjustments are based on clinical response and tolerability, and the maximum daily dose should not exceed 10 mg. Myalept must be reconstituted with sterile water for injection prior to use and administered under the guidance of a healthcare professional familiar with metabolic disorders.

    Ingredients

    Each vial contains 11.3 mg of metreleptin as the active ingredient. After reconstitution, the solution delivers 5 mg/mL of metreleptin. Inactive ingredients include glycine, sucrose, polysorbate 20, glutamic acid, and sodium hydroxide for pH adjustment.

    Contraindications

    Myalept is contraindicated in patients with general obesity not associated with congenital or acquired generalized lipodystrophy. It should not be used in patients with hypersensitivity to metreleptin or any component of the formulation. Additionally, due to an increased risk of T-cell lymphoma, it is contraindicated in patients with acquired generalized lipodystrophy and evidence of active or suspected malignancy.

    Cautions

    Treatment with Myalept may lead to the development of anti-metreleptin antibodies, which may reduce its efficacy and pose a risk of severe infections. Cases of T-cell lymphoma have been reported, particularly in patients with autoimmune hepatitis or immunodeficiency. Regular monitoring of metabolic parameters, liver function, and signs of malignancy is advised. Myalept should be used with caution in patients with a history of autoimmune disease, and it is not recommended during pregnancy unless clearly needed.

    Side Effects

    Common side effects include:

    • Hypoglycemia (especially when used with insulin or antidiabetic medications)
    • Headache
    • Abdominal pain
    • Injection site reactions
    • Weight loss
    • Fatigue

    Serious but less common side effects may include:

    • Development of neutralizing antibodies
    • Lymphoma
    • Pancreatitis
    • Autoimmune disease exacerbation

    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 : 14194

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