狄诺塞麦要注意哪些事项呢？

Denosumab is an injectable drug for breast cancer with a special mechanism of action. Many other targeted drugs will cause the patient's bone density to decrease after treatment, thereby increasing the risk of fractures. However, Denosumab can reduce bone absorption and increase bone density, so it is often used to treat osteoporosis in postmenopausal women who are at higher risk of fractures.

What should patients pay attention to when using Denosumab?

1. Hypocalcemia. Use of denosumab can cause severe hypocalcemia. Correct pre-existing hypocalcemia before denosumab treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when denosumab is administered with other drugs that can also reduce calcium levels. Advise patients to seek medical attention for symptoms of hypocalcemia.

2. According to clinical trials using lower doses of denosumab, patients with creatinine clearance less than 30 mL/min or receiving dialysis are at higher risk of severe hypocalcemia than patients with normal renal function. In a trial of 55 patients, free of cancer and with varying degrees of renal impairment, receiving a single dose of 60 mg denosumab, 8/17 patients had a creatinine clearance less than 30 mL/min or underwent dialysis and had a corrected serum calcium level less than 8.0 mg/dL compared with 0/12 patients with normal renal function. The risk of hypocalcemia with the recommended dosing regimen of 120 mg every 4 weeks has not been evaluated in patients with creatinine clearance less than 30 mL/min or receiving dialysis.

3. Osteonecrosis of the jaw (ONJ). Osteonecrosis of the jaw, manifested by jaw pain, osteomyelitis, osteitis, bone erosion, dental or periodontal infection, toothache, gingival ulceration, or gingival erosion, may occur in patients receiving denosumab. Persistent pain or slow healing of the back of the mouth or jawbone from dental surgery may also be signs of ONJ. In clinical trials, ONJ occurred in 2.2% of patients receiving denosumab, and of these patients, 79% had a history of tooth extraction, poor oral hygiene, or use of dental instruments. Perform oral examinations and appropriate preventive dentistry before starting denosumab and periodically during denosumab treatment. Remind patients about oral hygiene habits. Avoid invasive dental procedures during treatment with denosumab.

4. There is no need to adjust the dose for the elderly and patients with renal insufficiency. For patients with severe renal insufficiency and those undergoing dialysis treatment, blood calcium monitoring should be carried out, and calcium and vitamin D supplementation should be paid attention to.

5. It is not yet clear whether denosumab (denosumab) can be excreted in breast milk. Breast-feeding women should weigh the importance of this product and choose to discontinue the drug or stop breastfeeding.

6. Pregnancy: Category C. There are no appropriate and well-controlled trials of denosumab in pregnant women. Denosumab should be used during pregnancy only if the potential benefits justifiably outweigh the potential risks to the fetus. Women who become pregnant during denosumab (denosumab) treatment are encouraged to enroll in the company's (denosumab) pregnancy monitoring program.