“Active ingredient (INN): Zoledronic acid
It has a pronounced effect of suppressing bone resorption and a direct antitumor effect. Effective for all types of bone metastases, hypercalcemia.
Directions for use and dosage:
IV, drip; infusion duration is at least 15 minutes. Frequency of appointment: every 3–4 weeks. For bone metastases of common malignant tumors and myeloma in adults and elderly patients, the recommended dose of the drug is 4 mg. Before administering the drug, dilute the concentrate (contents of 1 vial) in 100 ml of solution for infusion that does not contain calcium (0.9% sodium chloride solution or 5% dextrose solution).
Patients should also be additionally prescribed calcium orally at a dose of 500 mg/day and vitamin D orally at a dose of 400 IU/day.
For hypercalcemia caused by a malignant tumor (albumin-corrected calcium concentration ≥12 mg/dL or 3 mmol/L), the recommended dose of the drug is 4 mg in adults and elderly patients. To ensure adequate hydration of the patient, it is recommended that saline be administered before, concurrently, or after Zometa infusion.
The decision to treat hypercalcemia caused by a malignant tumor with Zometa in patients with severe renal impairment should be made only after a careful assessment of the risks of using the drug and the expected benefits of therapy. Patients whose serum creatinine concentration is <400 µmol/L or <4.5 mg/dL do not require dosage adjustment.
For bone metastases of common malignant tumors and myeloma, the dose of Zometa depends on the initial level of creatinine clearance, calculated using the Cockcroft-Gault formula. It is not recommended to use Zometa in patients with severe renal impairment (creatinine Cl values ≤30 ml/min).
After initiating Zometa therapy, serum creatinine concentrations should be determined before each dose of the drug. If renal dysfunction is detected, the next administration of Zometa should be postponed. Renal dysfunction is determined by the following parameters:
– for patients with normal initial creatinine values (<1.4 mg/dl) – an increase in serum creatinine concentration by 0.5 mg/dl.
– for patients with deviations in the initial level of creatinine (>1.4 mg/dl) – an increase in serum creatinine concentration by 1 mg/dl.
Zometa therapy is resumed only after creatinine levels reach values within 10% of the initial value, at the same dose that was used before treatment was interrupted.
Rules for preparing a solution for infusion:
A solution for infusion is prepared from a concentrate of 4 mg/5 ml (contents of 1 vial). The solution should be prepared under aseptic conditions. Before administering the drug, dilute the concentrate (contents of 1 vial or a smaller volume, if required) in 100 ml of solution for infusion that does not contain calcium (0.9% sodium chloride solution or 5% dextrose solution). It is advisable to use the prepared Zometa solution immediately after preparation. If not used immediately, the solution can be stored in the refrigerator at a temperature of 2–8 °C for no more than 24 hours. Before administration, the solution should be kept indoors until it reaches room temperature.
The total time between diluting the concentrate, storing the prepared solution in the refrigerator at a temperature of 2–8 °C and the end of the drug administration should not exceed 24 hours.
Zometa solution should not be mixed with any other medications. Zometa should not be mixed with any solutions containing calcium or any other divalent cations, such as lactated Ringer’s solution. The prepared zoledronic acid solution must be administered using a separate IV infusion system.
IV drip, for at least 15 minutes.
Contraindications:
– hypersensitivity to zoledronic acid, other bisphosphonates and other components of the drug;
-pregnancy;
– lactation period (breastfeeding).
– hypersensitivity to zoledronic acid, other bisphosphonates or any other components included in the drug;
– severe renal failure (Cl creatinine <30 ml/min);
-children and adolescents (safety and effectiveness of use have not been established).
With caution: impaired renal function, severe liver failure (no data on use), patients with bronchial asthma, sensitive to acetylsalicylic acid.”
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