地诺单抗什么时候上市的呢？

It is approved for the prevention of bone-related events in patients with bone metastases from solid tumors. It is not indicated for the prevention of bone-related events in patients with multiple myeloma, or for the treatment of hypercalcemia in adults or bone-mature adolescents with giant cell tumors of bone who are unresectable or surgically resectable malignancies that may cause serious complications and are bisphosphonate-resistant.

So, when was denosumab launched?

Time on the market of denosumab: Denosumab was first approved in the United States in 2010 for the prevention of bone-related events in adults with bone metastases from solid tumors. In 2011, it was also approved for the same indication in Europe. As medical research advances, the U.S. Food and Drug Administration (FDA) has approved an expansion of its denosumab for the treatment of giant cell tumor of bone (GCTB) in adults and certain adolescents, making it the first drug to treat this rare disease in the United States.

Precautions for 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 (such as phosphorus and magnesium) 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 infection. 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 (which can occur spontaneously) is usually accompanied by tooth extraction and local infection that delays healing. Routine oral examinations should be performed before starting treatment, and good oral hygiene should be maintained after treatment begins. 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.