Sandronic Dosage/Direction for Use

DOSAGE: SANDRONIC 4 mg/100 mL solution for infusion is a ready to use presentation and must not be further diluted or mixed with other infusion solutions except for patients with renal impairment. It should be administered as a single intravenous solution in a separate infusion line in no less than 15 minutes.
Prevention of skeletal related events in patients with advanced malignancies involving bone: In adults and elderly patients the recommended SANDRONIC dose is a single 4 mg infusion given every 3-4 weeks.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Treatment of Hypercalcemia of Malignancy (HCM): In adults and elderly patients the recommended SANDRONIC dose in hypercalcemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/L) is a single 4 mg infusion. Patients must be maintained well hydrated prior to and following administration of SANDRONIC.
Treatment of patients with renal impairment: Patients with hypercalcemia of malignancy (HCM): SANDRONIC treatment in patients with hypercalcemia of malignancy (HCM) and who have severe renal impairment should be considered only after evaluating the risks and benefit of treatment. No dose adjustment is necessary in HCM patients with serum creatinine < 400 micromol/L or 4.5 mg /dL (see Precautions).
Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with SANDRONIC in patients with multiple myeloma or metastatic bone lesions from solid tumors, serum creatinine levels and creatinine clearance (CrCl) should be determined. CrCl is calculated from serum creatinine levels using the Cockcroft-Gault formula. SANDRONIC is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CrCl < 30 mL/min.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CrCl 30-60 mL/min, the following SANDRONIC dose is recommended. (See Table 1.)


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Following initiation of therapy, serum creatinine should be measured prior to each dose of SANDRONIC and treatment should be withheld if renal function has deteriorated. Renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dL) an increased of ≥ 0.5 mg/dL.
For patients with an abnormal baseline serum creatinine (> 1.4 mg/dL) an increased of > 1.0 mg/dL.
SANDRONIC treatment was resumed only when the creatinine level returned to within 10% of the baseline value. SANDRONIC should be resumed at the same dose as that prior to treatment interruption.
Administration: Zoledronic Acid Monohydrate must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zoledronic Acid Monohydrate must not be mixed with calcium or other divalent cation containing infusion solutions, such as Lactated Ringer's solution, and should be administered as a single intravenous solution in a line separate from all other drugs in no less than 15 minutes. Patients must be maintained in a well hydrated state prior to and following administration of Zoledronic Acid Monohydrate.
Preparation of reduced SANDRONIC doses: In patients with mild to moderate renal impairment in patients with HCM, which is defined as CrCl 30 to 60 mL/min, reduced SANDRONIC dosages are recommended: See Table 2.


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