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Ganite (Gallium Nitrate) - Summary

 


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WARNING

Concurrent use of gallium nitrate with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk for developing severe renal insufficiency in patients with cancer-related hypercalcemia. If use of a potentially nephrotoxic drug is indicated during gallium nitrate therapy, gallium nitrate administration should be discontinued and it is recommended that hydration be continued for several days after administration of the potentially nephrotoxic drug. Serum creatinine and urine output should be closely monitored during and subsequent to this period. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.

 

GANITE SUMMARY

Gallium nitrate injection is a clear, colorless, odorless, sterile solution of gallium nitrate, a hydrated nitrate salt of the group IIIa element, gallium. Gallium nitrate is formed by the reaction of elemental gallium with nitric acid, followed by crystallization of the drug from the solution. The stable, nonahydrate, Ga(N03)3•9H2O is a white, slightly hygroscopic, crystalline powder of molecular weight 417.87, that is readily soluble in water. Each mL of Ganite (gallium nitrate injection) contains gallium nitrate 25 mg (on an anhydrous basis) and sodium citrate dihydrate 28.75 mg. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment to 6.0-7.0.

Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.


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GANITE NEWS HIGHLIGHTS

Published Studies Related to Ganite (Gallium Nitrate)

Randomized, double-blind, phase II trial of gallium nitrate compared with pamidronate for acute control of cancer-related hypercalcemia. [2006.01]

Microscopic investigation of the use of gallium nitrate for root surface treatment in rat teeth submitted to delayed replantation. [2007]

Effect of gallium nitrate on tamoxifen induced hypercalcemia in rats bearing mammary tumor. [2006.06]

Antimicrobial activity of gallium against virulent Rhodococcus equiin vitro and in vivo. [2006.04]

Tamoxifen flare hypercalcemia: an additional support for gallium nitrate usage. [2006]

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Clinical Trials Related to Ganite (Gallium Nitrate)

Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma [Completed]

Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma [Completed]

Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors [Completed]

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Page last updated: 2008-03-26

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