Zoledronic acid

【Product name】Zoledronic, RECLAST, ZOMETA

[English common name]Zoledronic

[Chinese common name]Zoledronic acid

[English name]

[Chinese other name]

[Indications] in combination with standard anti-tumor drug therapy for the treatment of patients with solid tumor bone metastases andMultiple myelomaThe patient's bone damage. It is used to treat hypercalcemia (HCM) caused by malignant tumors.

[Usage and Dosage] This product should not be used in combination with an infusion solution containing calcium or other divalent cations (such as lactated Ringer's solution). A single intravenous infusion should be performed using an infusion tube separate from other drugs.
Adult and elderly
The recommended dose is 4 mg. Dilute with 100 ml of 0.9% sodium chloride or 5% dextrose solution for an intravenous infusion of not less than 15 minutes (see [Precautions]).
For patients with HCM (albumin-corrected serum calcium ≥ 3.0 mmol/l or 12 mg/dl), a single infusion should be accepted. Albumin-corrected serum calcium (mg/dL) = patient serum calcium (mg/dL) + 0.8 x [median serum albumin (g/L) - patient serum albumin (g/L)].
There is limited experience with re-treatment of hypercalcemia. Re-treatment must be at least 7-10 days apart from the previous one, and serum creatinine levels should be monitored before treatment.
The hydration status of the patient must be tested prior to administration and should be administered according to the clinical condition of the patient.
For patients with bone metastases and multiple myeloma, this product should be given every 3-4 weeks. In addition, patients should take 500 mg of calcium and 400 IU of vitamin D daily.
Renal insufficiency
HCM
For patients with HCM with severe renal impairment, the risk-benefit ratio needs to be assessed before considering the use of this product for treatment. In previous clinical trials, patients with serum creatinine >400 umol/l or >4.5 mg/dl were not enrolled. HCM patients with serum creatinine <400umol/l or <4.5mg/dl do not need to adjust the dose.
Patient who has developed bone metastasis
For patients with multiple myeloma and solid tumors that have undergone bone metastases, serum creatinine and creatinine clearance (CrCl) are measured at the start of treatment with this product. The CrCl value was calculated from the serum creatinine concentration value using the Cockcroft-Gault formula. Before using Zetai drugs for treatment, if the patient has developed severe renal insufficiency symptoms (CrCl<30ml/min), it is recommended to give Zetai drugs according to the following dosages (see [Precautions]): CrCl>60ml /min: 4.0 mg; CrCl 50-60 ml/min: 3.5 mg; CrCl40-49 ml/min: 3.3 mg; CrCl30-39 ml/min: 3.0 mg.
This dose was calculated based on the assumed AUS target value of 0.66 (mgxhr/l) (CrCl = 75 ml/min). The purpose of using this dose reduction method is to achieve the same AUC value for patients with renal insufficiency as patients with creatinine clearance of 75 ml/min.
After starting the medication, the serum creatinine concentration of the patient is measured before each administration of the product. Once the patient's renal function is found to be deteriorating, medication withdrawal is required. In clinical trials, the definition of deterioration of renal function is this:
Serum creatinine concentrations increased from baseline normal (dl) to ≥0.5 mg/dl; and serum creatinine concentrations increased from baseline outliers (>1.4 mg/dl) to >1.0 mg/dl.
In clinical studies, treatment of this product is continued only when creatinine levels are restored to within 10% of the baseline value (see [Precautions]). The dose of drug used to re-use Zetai should be the dose of the drug used in the previous treatment interruption.
Hepatic insufficiency
Because of the limited clinical data on patients with severe hepatic insufficiency, there are no specific recommendations for such patients.
Child medication
The safety and effectiveness of this product for children and adolescents has not yet been established.

[Storage]Store below 30 °C.

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