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The Zometa 4 mg/100 mL solution for infusion is ready to use 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 IV solution in a separate infusion line in no less than 15 min.
Patients should also be administered an oral calcium supplement of 500 mg and vitamin D 400 IU daily.
Treatment of Hypercalcemia of Malignancy (HCM): Adults and Elderly: The recommended dose is 4 mg single infusion. Patients must be maintained well hydrated prior to and following administration of Zometa.
Renal Impairment: Zometa treatment in adult patients with HCM who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. In the clinical studies, patients with serum creatinine >400 micromol/L or >4.5 mg/dL were excluded. No dose adjustment is necessary in HCM patients with serum creatinine <400 micromol/L or <4.5 mg/dL (see Precautions).
When initiating treatment with Zometa, serum creatinine levels and CrCl should be determined. Creatinine clearance is calculated from serum creatinine levels using the Cockcroft-Gault formula. Zometa 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 clinical trials with Zometa, patients with serum creatinine ≥265 micromol/L or ≥3 mg/dL were excluded.
In all patients except patients with HCM presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for these populations as CrCl 30-60 mL/min, the following Zometa dose is recommended (see Table 5 and Precautions).
Click on icon to see table/diagram/imageFollowing initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated. In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (<1.4 mg/dL), an increase of ≥0.5 mg/dL; for patients with an abnormal baseline creatinine (>1.4 mg/dL), an increase of ≥1 mg/dL.
In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see Precautions). Zometa should be resumed at the same dose as that prior to treatment interruption.
Administration: Zometa must only be administered to patients by healthcare professionals experienced in the administration of IV bisphosphonates.
Zometa must not be mixed with calcium or other divalent cation-containing infusion solutions eg, Lactated Ringer's solution and should be administered as a single IV solution in a line separate from all other drugs in no less than 15 min.
Patients must be maintained in a well-hydrated state prior to and following administration of Zometa.
Preparation of Reduced Zometa Doses: In patients with mild to moderate renal impairment, which is defined as CrCl 30-60 mL/min, reduced Zometa dosages are recommended, except in patients with HCM.
To prepare reduced doses of Zometa 4 mg/5 mL concentrate, withdraw an appropriate volume of the liquid concentrate needed as follows: 4.4 mL, 4.1 mL and 3.8 mL for 3.5-mg, 3.3-mg and 3-mg doses, respectively.
The withdrawn amount of liquid concentrate must be further diluted in 100 mL of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution. The dose must be given as a single IV infusion of no less than 15 min.
To prepare reduced doses of Zometa 4 mg/100 mL solution for infusion, remove the corresponding volume of Zometa solution as indicated as follows and replace it with an equal volume of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution. (See Table 6.)
Click on icon to see table/diagram/image