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Tymlos (Abaloparatide)

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    Description

    Tymlos (abaloparatide) is a human parathyroid hormone-related peptide (PTHrP) analog used for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. It is also indicated to increase bone density in men with osteoporosis at high risk for fracture. Abaloparatide stimulates osteoblast activity and increases bone formation, thereby improving bone mineral density (BMD) and reducing the risk of vertebral and nonvertebral fractures. Tymlos is administered via subcutaneous injection and is typically reserved for patients who cannot tolerate other osteoporosis therapies or for whom they have proven ineffective.

    Directions

    Tymlos is administered as a subcutaneous injection of 80 micrograms once daily into the periumbilical region of the abdomen. It should be taken at approximately the same time each day, with or without food. Patients should be trained on proper injection technique and site rotation to reduce the risk of injection site reactions. The recommended treatment duration is limited to a cumulative total of 2 years during a patient's lifetime due to the potential risk of osteosarcoma observed in animal studies. After completing Tymlos therapy, patients are typically transitioned to an antiresorptive agent to maintain BMD gains.

    Ingredients

    Each 80 mcg dose of Tymlos (in 40 mcg/80 mcL solution) contains:

    • Abaloparatide
    • Phenol (preservative)
    • Acetic acid
    • Sodium acetate trihydrate
    • Mannitol
    • Water for injection

    The solution is provided in a multi-dose prefilled pen.

    Contraindications

    Tymlos is contraindicated in patients with:

    • Known hypersensitivity to abaloparatide or any component of the formulation
    • Pre-existing hypercalcemia
    • Metabolic bone diseases other than osteoporosis
    • Unexplained elevations of alkaline phosphatase
    • A history of osteosarcoma or patients at increased risk of osteosarcoma, including those with Paget’s disease, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton

    Cautions

    Patients should be monitored for signs of hypercalcemia, particularly those with predisposing conditions. Tymlos may cause orthostatic hypotension, especially with the first few doses; patients should be advised to sit or lie down if symptoms occur. Caution is advised in patients with severe renal impairment, as safety and efficacy have not been fully established. Use beyond the recommended 2-year lifetime duration should be avoided due to the theoretical risk of osteosarcoma.

    Side Effects

    Common side effects of Tymlos include:

    • Dizziness
    • Nausea
    • Headache
    • Palpitations
    • Fatigue
    • Upper abdominal pain
    • Injection site reactions
    • Hypercalciuria
    • Orthostatic hypotension

    Less common but serious adverse events may include symptomatic hypercalcemia or allergic reactions. Regular monitoring of serum calcium, renal function, and urinary calcium excretion is recommended.

    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 : 14904

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