骨转移药物狄诺塞麦说明书

Bone metastasis drug (denosumab) instructions

Generic name: denosumab

Product name: Xgeva

Full names: denosumab, denosumab, denosumab, Xgeva, Denosumab

Indications:

(1) Bone metastases from solid tumors: Denosumab (denosumab) is suitable for preventing bone-related events in patients with bone metastases from solid tumors. (2) Important limitations of use: Not suitable for prevention of bone-related events in patients with multiple myeloma.

Usage and dosage:

Denosumab (denosumab) is given as a subcutaneous injection of 120 mg into the upper arm, upper thigh, or abdomen every 4 weeks, with calcium and vitamin D when needed to treat or prevent hypocalcemia.

Side effects:

The side effects of denosumab (denosumab) are usually accompanied by the drug during treatment. Side effects of >10% using denosumab include back pain (incidence rate 34.7%) and limb pain (11.7%). Side effects <10% include: musculoskeletal pain, hypercholesterolemia, upper respiratory tract infection, pharyngitis, pneumonia, cystitis, anemia, atrial fibrillation, angina, dizziness, peripheral edema, asthenia, shingles, abdominal pain, gastroesophageal reflux disease, flatulence, spinal osteoarthritis, rash, pruritus, sciatica, insomnia.

Special groups:

Pregnancy: Denosumab (denosumab) Based on animal data, denosumab may cause fetal harm. Pregnancy monitoring programs are available.

Nursing Mothers: Breast development and lactation may be impaired. Discontinue denosumab medication or breast-feeding.

Pediatric Patients: The safety and effectiveness of denosumab have not been established.

Renal Impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Appropriate supplements of calcium and vitamin D.

【Notes】

Hypocalcemia, severe hypocalcemia, may occur in patients receiving denosumab (denosumab). Correct hypocalcemia before initiating denosumab. Monitor calcium levels and appropriately supplement all patients with calcium and vitamin D.

Osteonecrosis of the jaw may occur in patients receiving denosumab. Have an oral examination before starting denosumab. Monitor for symptoms. Avoid invasive dental procedures during treatment with denosumab.

Mechanism of action:

Denosumab (denosumab) is the first approved monoclonal antibody that specifically targets RANK ligand. RANK ligand is a transmembrane or soluble protein that is necessary for osteoclasts to maintain their structure, function, and survival. Human RANKL mRNA is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts. Osteoclasts are responsible for bone resorption, and osteoclast precursors must have low levels of macrophage colony-stimulating factor and RANKL during their differentiation into mature osteoclasts. Denosumab has a high affinity with RANKL, preventing RANK ligand from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone resorption, increasing bone density and bone strength of both cortical bone and trabecular bone, promoting bone reconstruction, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women.

The above is the content of the (denosumab) instruction manual, I hope it can help you!