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Therapeutics
Denosumab (Prolia)

Denosumab (Prolia)

Immunological Agent | Monoclonal Antibody

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The Black Boxed Warning for Prolia (denosumab) states that the osteoporosis medicine increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including patients on dialysis. This risk is further increased in the presence of chronic kidney disease-mineral and bone disorder.
  1. Indications and Uses:
      • Prolia (denosumab) is primarily used for treating osteoporosis in postmenopausal women and men at high risk of fractures. It is also used for osteoporosis in patients receiving corticosteroids and for certain patients with bone loss due to hormone ablation therapy for cancer (NCBI, Prolia Official Site).
  1. Administration:
      • Prolia is administered via subcutaneous injection every six months by a healthcare professional. It should not be given intramuscularly (MedlinePlus).
  1. Calcium and Vitamin D Supplementation:
      • It's important to ensure adequate intake of calcium and vitamin D before and during Prolia therapy to reduce the risk of hypocalcemia. Patients should be advised to maintain their calcium and vitamin D levels (FDA).
  1. Monitoring:
      • Monitor patients for signs of hypocalcemia, especially in the first several weeks after initiating therapy. Regular follow-up and lab tests (serum calcium, vitamin D levels) are recommended to catch any early signs of adverse effects (NCBI).
  1. Side Effects:
      • Common side effects include musculoskeletal pain, hypercholesterolemia, and increased risk of infections (GoodRx). Serious side effects include osteonecrosis of the jaw and atypical femur fractures. These risks should be communicated to patients (Drugs.com).
  1. Precautions:
      • Prolia is contraindicated in patients with pre-existing hypocalcemia. Special caution is needed for patients with severe renal impairment or dialysis due to the increased risk of severe hypocalcemia (FDA).
  1. Bone Density Improvement:
      • Prolia is effective in improving bone density and reducing the risk of fractures by slowing bone resorption (Prolia Official Site).
  1. Discontinuation Risks:
      • Abrupt discontinuation of Prolia can lead to rapid bone loss and an increased risk of multiple vertebral fractures. A transition plan to another antiresorptive agent should be considered if therapy is stopped (Healthline).
  1. Patient Education:
      • Patients should be educated about maintaining oral hygiene and visiting their dentist regularly to prevent osteonecrosis of the jaw. They should also be aware of the signs of serious infections and instructed to seek medical attention if symptoms occur (NCBI).
 
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