Treatment Options Role of BMAs in the Presence of Extraskeletal Metastases
ÎStarting bisphosphonates or other BMAs in women without evidence of bone metastases, even in the presence of extraskeletal metastases, is NOT recommended.
> This clinical situation has been inadequately studied using IV bisphosphonates or other BMAs and should be the focus of new clinical trials.
Laboratory Monitoring
ÎSerum creatinine should be monitored prior to each dose of pamidronate or zoledronic acid, in accordance with FDA-approved labeling.
ÎSerum calcium, electrolytes, phosphate, magnesium, and hematocrit/ hemoglobin should also be monitored regularly.
> There is no evidence to guide the interval for monitoring serum calcium, electrolytes, phosphate, magnesium, and hematocrit/hemoglobin with denosumab, pamidronate, or zoledronic acid.
Renal Safety Concerns
ÎUse of BMAs among patients with reduced renal function has been incompletely assessed.
ÎMonitor for hypocalcemia in patients with impaired creatinine clearance.
> The risk of hypocalcemia with denosumab dosed at 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance < 30 mL/min or receiving dialysis.
ÎInfusion times < 2 hours with pamidronate or < 15 minutes with zoledronic acid should be AVOIDED.
ÎIn patients with a calculated serum creatinine clearance > 60 mL/min, no change in dosage, infusion time, or interval of pamidronate or zoledronic acid administration is required.
ÎThe packet insert of zoledronic acid provides guidance for dosing when baseline serum creatinine clearance is between 30 and 60 mL/min.
Osteonecrosis of the Jaw (ONJ)
ÎONJ is an uncommon but potentially serious condition associated with the use of BMAs.
ÎThe Update Committee concurs with the revised FDA label for zoledronic acid and pamidronate and the FDA label for denosumab and recommends that all patients with cancer receive a dental examination and necessary preventive dentistry prior to initiating therapy with inhibitors of osteoclast function, unless there are mitigating factors that preclude the dental assessment.
ÎWhile receiving inhibitors of osteoclast function, patients should maintain optimal oral hygiene and, if possible, avoid invasive dental procedures that involve manipulation of the jaw bone or periosteum.
