During treatment, serum creatinine should be measured before each Zometa dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:

For patients with normal baseline creatinine, increase of 0.5 mg/dL

For patients with abnormal baseline creatinine, increase of 1.0 mg/dL

In the clinical studies, Zometa treatment was resumed only when the creatinine returned to within 10% of the baseline value. Zometa should be reinitiated at the same dose as that prior to treatment interruption.

Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.

Table 1: Reduced Doses for Patients with Baseline CrCl <60 mL/min Baseline Creatinine Clearance (mL/min)  Zometa Recommended Dose* 
>60 4 mg
50 - 60 3.5 mg
40 - 49 3.3 mg
30 - 39 3 mg
*Doses calculated assuming target AUC of 0.66(mg•hr/L) (CrCl = 75 mL/min) 

4 mg Dose

Vials of Zometa concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid). This concentrate should immediately be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.

Preparing Reduced Doses for Patients with Baseline CrCl ≤60 mL/min

Withdraw the appropriate volume of the Zometa concentrate from the vial for the dose required (see Table 2).

The withdrawn concentrate must be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP.

For All Prepared Doses

If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2°C-8°C (36°F-46°F). The refrigerated solution should then be equilibrated to room temperature prior to administration. The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours.

Zometa 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.

Table 2: Preparation of Reduced Doses Zometa Volume (mL)  Dose (mg) 
4.4 3.5
4.1 3.3
3.8 3.0

Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes [see Warnings And Precautions (5.2)]. In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis, have occurred in patients, including those treated with the approved dose of 4 mg infused over 15 minutes. There have been instances of this occurring after the initial Zometa dose.

4 mg/5 mL single-dose vial

Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2)].

Zometa contains the same active ingredient as found in Reclast (zoledronic acid). Patients being treated with Zometa should not be treated with Reclast.

Patients with hypercalcemia of malign