Formulation and Specifications: Injection: 120 mg (1.7 ml)/vial
Indications: Treatment of non-surgically resectable or surgically resectable giant cell tumors of bone that may result in severe functional impairment, including adults and adolescent patients with mature skeletal development (defined as at least one mature long bone and weight ≥45 kg).
Key points for rational drug use:
1. Disulfiramab treatment 120 mg is administered subcutaneously (upper arm, thigh, or abdomen) every 4 weeks, with intravenous, intramuscular, and intradermal injections prohibited, and one supplemental subcutaneous injection of disulfiramab 120 mg on days 8 and 15 of the first month of treatment.
2. Blood calcium levels must be tested prior to treatment with disulfiramab, and hypocalcemia, if any, must be corrected first. For patients with a predisposition to hypocalcemia and imbalances in mineral metabolism (e.g., history of hypoparathyroidism, history of thyroid and parathyroid surgery, malnutrition, small bowel resection, severe renal impairment such as creatinine clearance ≤ 30 ml/min and/or receiving dialysis and inadequate/no calcium supplementation), clinical monitoring of creatinine and electrolyte levels (e.g., phosphorus and magnesium) is required and such Patients should be monitored closely for symptoms of hypocalcemia and given 500 mg of calcium and 400 IU of vitamin D daily to treat or prevent hypocalcemia. Disulfiramab should not be used in combination with bisphosphonates.
Patients taking immunosuppressive drugs or with compromised immune systems may be at increased risk of serious infections with disulfiramab and the benefit-risk ratio should be fully considered before administration. Physicians should assess the risk of continued use in patients who develop serious infections with disulfiramab.
4. Osteonecrosis of the jaw (which can occur spontaneously) usually occurs with tooth extraction and delayed healing of local infections. Routine oral examination should be performed before starting treatment with disulfiramab and good oral hygiene should be maintained after the start of treatment. Avoid invasive dental procedures and operations (e.g., tooth extraction, dental implants, bone surgery, etc.) during treatment. If osteonecrosis of the jaw occurs, the treatment for osteonecrosis of the jaw may in turn aggravate the disease, and discontinuation of the drug should be considered at this time.
5. Women of childbearing age are advised to use effective contraception during treatment and for at least 5 months after the last dose of treatment.
6. Common adverse reactions include arthralgia, headache, nausea, back pain, fatigue, and pain in the extremities.
※7. Other FDA-approved indications include: prevention of bone-related events in patients with multiple myeloma and solid tumor bone metastases; hypercalcemia due to bisphosphonate-refractory malignancies.
*8. The marketing application for a new indication for dextranumab for the prevention of bone-related events in patients with multiple myeloma and solid tumor bone metastases was formally accepted by the State Drug Administration in April 2020.