Pamidronate Disodium

Indications

INDICATIONS AND USAGE Hypercalcemia of Malignancy 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Hypercalcemia of Malignancy Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful. Moderate Hypercalcemia The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE DOSE, intravenous infusion over 2 to 24 hours.

Contraindications

CONTRAINDICATIONS Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

Warnings and precautions

WARNINGS Deterioration in Renal Function 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).

Storage and supply

HOW SUPPLIED Vials – 3 mg/mL, 10 mL vial - each contains 30 mg of Pamidronate Disodium and 470 mg of Mannitol, USP in 10 mL Water for Injection, USP. Unit of Sale Concentration NDC 61703-324-18 Carton of 1 Single-dose vial 30 mg/10 mL (3 mg/mL) Vials – 6 mg/mL, 10 mL vial - each contains 60 mg of Pamidronate Disodium and 400 mg of Mannitol, USP in …

Source: Pamidronate Disodium (Pamidronate Disodium) — US FDA prescribing information, 2026-05-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.