用地舒单抗要注意什么？

Also called denosumab, in June 2010, the FDA approved denosumab (trade name: Prolia) for the treatment of osteoporosis in postmenopausal women. It was later approved for the treatment of male osteoporosis, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer. In November of the same year, based on the results of three randomized controlled phase III clinical studies, the FDA approved denosumab for the treatment of skeletal-related events in patients with bone metastases from solid tumors, and was later approved for the treatment of giant cell tumor of bone and malignant hypercalcemia.

In order to ensure the effective effect of the drug, what should we pay attention to when using denosumab?

1. Hypocalcemia must be corrected before denosumab treatment is started. For patients who are prone to hypocalcemia and mineral metabolism imbalance (such as those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), clinical monitoring of creatinine and mineral levels is required, and such patients should be instructed to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D.

2. Patients who are concurrently taking immunosuppressants or have compromised immune systems may have an increased risk of serious infections. Physicians must fully consider the benefit-risk ratio before prescribing denosumab to such patients. Physicians should evaluate the need to continue denosumab therapy in patients who develop serious infections while taking denosumab.

3. Osteonecrosis of the mandible usually occurs with tooth extraction and local infection that delays healing. A routine oral examination should be performed before starting denosumab treatment, and good oral hygiene should be maintained after treatment is started. If a patient develops osteonecrosis of the jaw, treatment for osteonecrosis of the jaw may worsen the condition, and discontinuation of the medication should be considered at this time.

4. Special groups: Pregnancy: According to animal data, it may cause fetal damage. Breastfeeding women: Breast development or breastfeeding may be impaired, discontinue medication or breastfeeding. Pediatric Patients: Comfort and effectiveness have not been established.