Risk of renal impairment may increase with underlying renal disease and dehydration secondary to fever, gastrointestinal losses, diuretic therapy, etc. Renal impairment has been observed following the administration of zoledronic acid, especially in patients with preexisting renal compromise or other risk factors including concomitant nephrotoxic medications, concomitant diuretic therapy, or severe dehydration occurring before or after Reclast administration. Renal impairment has been observed in patients after a single administration. Rare reports of hospitalization and/or dialysis occurred in patients with underlying moderate to severe renal impairment. Renal impairment may lead to increased exposure of concomitant medications that are primarily renally excreted. Serum creatinine should be measured before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider interim monitoring of serum creatinine in at-risk patients. Patients, especially those receiving diuretic therapy, should be appropriately hydrated prior to administration of Reclast. Reclast should be used with caution with other nephrotoxic drugs. Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney (Prod Info RECLAST(R) IV injection, 2011). Zometa 4 mg as a single-dose intravenous infusion over no less than 15 minutes every 3-4 weeks for patients with Clcr of >60 mL/min Reduce the dose for patients with renal impairment [see table below] Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg. Treatment in patients with severe renal impairment is not recommended. In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis have occurred in patients with normal and abnormal baseline renal function, including patients treated with 4 mg infused over a 15-minute period. There have been instances of this occurring after the initial Zometa dose. Reduced Doses for Patients with Baseline CrCl <60 mL/min: Baseline Creatinine Zometa Recommended Dose * Clearance (mL/min) 50-60 3.5 mg 40-49 3.3 mg 30-39 3.0 mg calculated assuming target AUC of 0.66 (mg•hr/L) (CrCl=75mL/min)
Risk of renal impairment may increase with underlying renal disease and dehydration secondary to fever, gastrointestinal losses, diuretic therapy, etc. Renal impairment has been observed following the administration of zoledronic acid, especially in patients with preexisting renal compromise or other risk factors including concomitant nephrotoxic medications, concomitant diuretic therapy, or severe dehydration occurring before or after Reclast administration. Renal impairment has been observed in patients after a single administration. Rare reports of hospitalization and/or dialysis occurred in patients with underlying moderate to severe renal impairment. Renal impairment may lead to increased exposure of concomitant medications that are primarily renally excreted. Serum creatinine should be measured before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider interim monitoring of serum creatinine in at-risk patients. Patients, especially those receiving diuretic therapy, should be appropriately hydrated prior to administration of Reclast. Reclast should be used with caution with other nephrotoxic drugs. Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney (Prod Info RECLAST(R) IV injection, 2011). Zometa 4 mg as a single-dose intravenous infusion over no less than 15 minutes every 3-4 weeks for patients with Clcr of >60 mL/min Reduce the dose for patients with renal impairment [see table below] Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg. Treatment in patients with severe renal impairment is not recommended. In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis have occurred in patients with normal and abnormal baseline renal function, including patients treated with 4 mg infused over a 15-minute period. There have been instances of this occurring after the initial Zometa dose. Reduced Doses for Patients with Baseline CrCl <60 mL/min: Baseline Creatinine Clearance (mL/min) Zometa Recommended Dose * 50-60 3.5 mg 40-49 3.3 mg 30-39 3.0 mg calculated assuming target AUC of 0.66 (mg•hr/L) (CrCl=75mL/min)
CKD%20Practice%20Guideline%20-2011%20Medication%20Review.docx