|Drug Name:||Pamidronate Disodium|
|Manufacturer:||Barr Laboratories, Inc.|
|Other Info:||Manufactured by PLIVA – Lachema a.s., Brno, Czech RepublicManufactured for Barr Laboratories, Inc., Pomona, NY 10970, USARevised JULY 2008BR-1195, 1192, 1196|
Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.
Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium.
Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment.
Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics).
Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided.
Diuretic therapy should not be employed prior to correction of hypovolemia.The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see DOSAGE AND ADMINISTRATION for appropriate infusion durations).
Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate.Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephritic syndrome, which may lead to renal failure, has been reported in pamidronate-treated patients, particularly in the setting of multiple myeloma and breast cancer.
Some of these patients had gradual improvement in renal status after pamidronate was discontinued.Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment.
Patients treated with pamidronate disodium for bone metastases should have the dose withheld if renal function has deteriorated.
(See DOSAGE AND ADMINISTRATION.)PREGNANCY: PAMIDRONATE DISODIUM SHOULD NOT BE USED DURING PREGNANCYPamidronate disodium may cause fetal harm when administered to a pregnant woman.
(See PRECAUTIONS, Pregnancy Category D.)There are no studies in pregnant women using pamidronate disodium.
If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Women of child-bearing potential should be advised to avoid becoming pregnant.Studies conducted in young rats have reported the disruption of dental dentine formation following single- and multi-dose administration of bisphosphonates.The clinical significance of these findings is unknown.