Zoledronic Acid Dosage

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Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma

Zometa:
4 mg given as a 15 minute intravenous infusion every 3 to 4 weeks.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors

Zometa:
4 mg given as a 15 minute intravenous infusion every 3 to 4 weeks.

Usual Adult Dose for Hypercalcemia of Malignancy

Zometa:
4 mg given as a 15 minute intravenous infusion. It is recommended that a minimum of 7 days elapse before retreatment.

Usual Adult Dose for Paget's Disease

Reclast:
5 mg zoledronic acid in 100 mL intravenous infusion given over a period of not less than 15 minutes.

Usual Adult Dose for Osteoporosis

Men, postmenopausal women and patients with glucocorticoid induced osteoporosis expected to be on glucocorticoids for at least 12 months (Reclast):
5 mg intravenous infusion once a year given over no less than 15 minutes.

Duration of therapy: Optimal duration has not been determined, but for patients at low-risk for fracture, consider discontinuation after 3 to 5 years.

Usual Adult Dose for Prevention of Osteoporosis

Reclast
For the prevention of glucocorticoid induced osteoporosis in patients expected to be on glucocorticoids for at least 12 months: 5 mg intravenous infusion once a year given over no less than 15 minutes.

For the prevention of osteoporosis in postmenopausal women:
5 mg intravenous infusion given once every 2 years intravenously over no less than 15 minutes. Patients must be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient. Postmenopausal women require an average of 1200 mg calcium and 800 to 1000 International Units of vitamin D daily.

Renal Dose Adjustments

Zometa:
For treatment of patients with multiple myeloma and metastatic bone lesions from solid tumors, the manufacturer recommends the following dose adjustments:
CrCl 50 to 60 mL/min: 3.5 mg
CrCl 40 to 49 mL/min: 3.3 mg
CrCl 30 and 39 mL/min: 3 mg
CrCl 29 mL/min or less: Not recommended

Renal function should be assessed before each dose and treatment should be withheld for renal deterioration, defined as follows: If the patient's serum creatinine is normal before treatment, and increases by 0.5 mg/dL within 2 weeks of the next dose, withhold the dose until the serum creatinine returns to within at least 10% of baseline. If the patient's serum creatinine is abnormal before treatment, and increases by 1 mg/dL within 2 weeks of the next dose, withhold the dose until the serum creatinine returns to within at least 10% of baseline.

Reclast:
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. There are no safety or efficacy data to support the adjustment of the Reclast dose based on baseline renal function. Therefore, no dosage adjustment is required in patients with a creatinine clearance of at least 35 mL/min.

Liver Dose Adjustments

Data not available

Dose Adjustments

If retreatment is necessary for patients with hypercalcemia of malignancy, at least 7 days should elapse after the previous dose. Renal function must be carefully monitored in all patients receiving zoledronic acid and possible deterioration in renal function must be assessed prior to retreatment.

Precautions

Patients with hypercalcemia of malignancy should be hydrated to restore urine output to 2 L/day before administration and during treatment.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Due to the potential nephrotoxicity of zoledronic acid, the patient's renal function should be monitored closely before and after treatment. Close monitoring of serum calcium, electrolytes, phosphate, magnesium, CBC, differential, and hematocrit/hemoglobin is also recommended.

Patients being treated for Paget's Disease with Reclast should receive 1500 mg elemental calcium in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units of vitamin D daily.

Patients being treated for multiple myeloma or metastatic bone lesions from solid tumors with Zometa should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily.

Zometa intravenous infusion should be given over no less than 15 minutes to reduce the incidence of renal toxicity and renal failure.

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