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Gallium Nitrate

Class: Bone Resorption Inhibitors
- Bone Resorption Inhibitors
ATC Class: V09HX01
VA Class: HS900
Chemical Name: Nitric acid gallium salt nonahydrate
Molecular Formula: GaN3O9•9H2O
CAS Number: 135886-70-3
Brands: Ganite

Medically reviewed on Jun 1, 2018


    Concomitant Use with Nephrotoxic Drugs
  • Risk of severe renal insufficiency in patients with cancer-related hypercalcemia when administered concomitantly with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B).1

  • Discontinue gallium if use of a potentially nephrotoxic drug is indicated; continue hydration for several days after administration of the nephrotoxic drug.1 Closely monitor Scr and urine output during and after this period.1 If Scr exceeds 2.5 mg/dL, discontinue gallium therapy.1


Bone resorption inhibitor.1

Uses for Gallium Nitrate


Used in conjunction with adequate hydration for the management of symptomatic hypercalcemia associated with malignant neoplasms in patients whose hypercalcemia is not adequately managed with conventional methods of treatment (e.g., hydration alone);1 3 4 designated an orphan drug by FDA for this use.5

More conservative measures than gallium therapy (e.g., hydration alone or combined with diuretics) generally are used for mild or asymptomatic hypercalcemia.1

Bladder Cancer

Has been used alone8 14 15 17 and in combination with other antineoplastic agents11 12 16 for the treatment of advanced or metastatic bladder carcinoma; however, other agents are preferred.6 9 18

Gallium Nitrate Dosage and Administration


  • Prior to initiating therapy, establish adequate hydration and urinary output in order to increase renal excretion of calcium.1 2

  • Maintain adequate hydration throughout therapy.1


IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by slow IV infusion.1


Dilute calculated daily dose, preferably in 1 L of 0.9% sodium chloride injection or 5% dextrose injection.1 Discard unused portion of vial.1

Rate of Administration

Administer by slow IV infusion over 24 hours.1




200 mg/m2 daily for 5 consecutive days.1 4

If used for mild hypercalcemia and few associated symptoms, 100 mg/m2 daily for 5 days may be used.1

If optimum serum calcium concentrations are achieved in <5 days, therapy may be discontinued early.1

Prescribing Limits



Safety and efficacy of repeated courses not established.1

Special Populations

Renal Impairment


Contraindicated in patients with severe renal impairment (Scr >2.5 mg/dL).1

Caution if used in patients with mild to moderate renal impairment (Scr 2–2.5 mg/dL); manufacturer makes no specific recommendations regarding dosage in these patients.1 (See Renal Impairment under Cautions.)

Cautions for Gallium Nitrate


  • Severe renal impairment (Scr >2.5 mg/dL).1



Renal Effects

Renal function abnormalities reported in clinical trials with gallium; hypercalcemia in cancer patients is commonly associated with impaired renal function.1

Establish adequate hydration and satisfactory urine output (e.g., 2 L daily) before initiating therapy.1 Maintain adequate hydration throughout treatment period.1 Avoid overhydration in patients with compromised cardiovascular status.1

Monitoring of Scr during gallium therapy is strongly recommended.1 Discontinue gallium if Scr >2.5 mg/dL.1

Concomitant use of gallium with other nephrotoxic drugs may increase the risk of renal insufficiency in patients with cancer-related hypercalcemia.1 (See Boxed Warning.)

General Precautions


Asymptomatic or mild to moderate hypocalcemia (6.5–8 mg/dL, corrected for albumin) may occur.1 Manufacturer recommends daily monitoring of serum calcium concentrations.1 If hypocalcemia occurs, discontinue gallium; short-term calcium replacement may be necessary.1


Transient hypophosphatemia may occur.1 Manufacturer recommends twice-weekly monitoring of serum phosphorus concentrations.1

Specific Populations


Category C.1


Not known whether gallium is distributed into milk.1 Discontinue nursing or the drug. 1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2

Renal Impairment

Contraindicated in patients with Scr >2.5 mg/dL.1 Safety and efficacy in these patients have not been examined systematically.1

If used in patients with Scr of 2–2.5 mg/dL, monitor renal function frequently.1 Discontinue if Scr increases beyond 2.5 mg/dL.1

Common Adverse Effects

Increased BUN and Scr, hypocalcemia, transient hypophosphatemia, decreased serum bicarbonate, decreased BP. 1

Interactions for Gallium Nitrate

Nephrotoxic Drugs

Potential increased risk of nephrotoxicity.1 Discontinue gallium if use of a potentially nephrotoxic drug is indicated; continue hydration for several days after administration of the nephrotoxic drug.1 Closely monitor Scr and urine output during and after this period.1 If Scr >2.5 mg/dL, discontinue gallium therapy.1

Specific Drugs




Dyspnea (occasionally associated with interstitial pneumonitis), mouth soreness, and asthenia reported in small number of multiple myeloma patients receiving low-dose gallium concomitantly with cyclophosphamide and prednisone1

Diuretics (e.g., furosemide)

No apparent adverse interaction1

Gallium Nitrate Pharmacokinetics


Serum Concentrations

Steady state reached in 24–48 hours.1



Not metabolized by liver or kidneys. 1

Elimination Route

Substantially excreted by kidneys.1 Average plasma clearance: 0.15 L/hour per kg. 1






Stable for 48 hours at 15–30°C or for 7 days at 2–8°C when diluted as recommended. 1


For information on systemic interactions resulting from concomitant use, see Interactions.


Solution Compatibility1


Dextrose 5% in water

Sodium chloride 0.9%

Y-Site CompatibilityHID


Acyclovir sodium

Allopurinol sodium



Ampicillin sodium-sulbactam sodium


Cefazolin sodium


Ceftriaxone sodium

Cimetidine HCl





Dexamethasone sodium phosphate

Diphenhydramine HCl




Granisetron HCl

Heparin sodium

Hydrocortisone sodium succinate


Magnesium sulfate


Melphalan HCl

Meperidine HCl


Methotrexate sodium

Metoclopramide HCl

Ondansetron HCl

Piperacillin sodium-tazobactam sodium

Potassium chloride

Ranitidine HCl

Sodium bicarbonate



Ticarcillin disodium-clavulanate potassium

Vancomycin HCl

Vinorelbine tartrate


Cefepime HCl



Doxorubicin HCl



Haloperidol lactate

Hydromorphone HCl

Imipenem-cilastatin sodium


Morphine sulfate

Prochlorperazine edisylate


  • Exerts hypocalcemic effect by inhibiting calcium resorption from bone, possibly by reducing increased bone turnover. 1

  • No cytotoxic effects were seen on bone cells of animals treated with gallium.1

Advice to Patients

  • Risk of renal function abnormalities, hypocalcemia, and transient hypophosphatemia.1 Importance of laboratory monitoring.1

  • Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Gallium Nitrate


Dosage Forms


Brand Names




25 mg/mL (500 mg)



AHFS DI Essentials™. © Copyright 2019, Selected Revisions June 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.


1. Genta incorporated. Ganite (gallium nitrate) injection prescribing information. Berkeley Heights, NJ; 2003 Sep.

2. Fujisawa Pharmaceutical Company: Personal communication.

3. Warrell RP Jr, Israel R, Frisone M et al. Gallium nitrate for acute treatment of cancer-related hypercalcemia: a randomized, double-blind comparison to calcitonin. Ann Intern Med. 1988; 108:669-74.

4. Bilezikian JP. Management of acute hypercalcemia. N Engl J Med. 1992; 326:1196-203.

5. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.

6. Scher HI, Shipley WU, Herr HW. Cancer of the bladder. In: DeVita VT Jr, Hellman S, Rosenberg SA eds. Cancer: principles and practice of oncology. 5th ed. Philadelphia: Lippincott-Raven Publishers; 1997:1300-22.

7. McCaffrey JA, Hilton S, Mazumdar M et al. Phase II randomized trial of gallium nitrate plus fluorouracil versus methotrexate, vinblastine, doxorubicin, and cisplatin in patients with advanced transitional-cell carcinoma. J Clin Oncol. 1997; 15:2449-55.

8. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92.

9. Roth BJ. Chemotherapy for advanced bladder cancer. Semin Oncol. 1996; 23:633-44.

10. Stadler WM, Kuzel T, Roth B et al. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol. 1997; 15:3394-8.

11. Dreicer R, Propert KJ, Roth BJ et al. Vinblastine, ifosfamide, and gallium nitrate—an active new regimen in patients with advanced carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group (E5892). Cancer. 1997; 79:110-4.

12. Einhorn LH, Roth BJ, Ansari R et al. Phase II trial of vinblastine, ifosfamide, and gallium combination chemotherapy in metastatic urothelial carcinoma. J Clin Oncol. 1994; 12:2271-6.

13. Roth BJ. Ifosfamide in the treatment of bladder cancer. Semin Oncol. 1996; 23(Suppl 6):50-5.

14. Crawford ED, Saiers JH, Baker LH et al. Gallium nitrate in advanced bladder cancer: Southwest Oncology Group study. Urology. 1991; 38:355-7.

15. Seligman PA, Crawford ED. Treatment of advanced transitional cell carcinoma of the bladder with continuous-infusion gallium nitrate. J Natl Cancer Inst. 1991; 83:1582-4.

16. Schultz P, Bajorin D, Kelly WK et al. Combination gallium nitrate and 5-fluorouracil for platinum-resistant metastatic transitional cell carcinoma of the bladder. Proc Annu Meet Am Soc Clin Oncol. 1993; 34:203.

17. Seidman AD, Scher HI, Heinemann MH et al. Continuous infusion gallium nitrate for patients with advanced refractory urothelial tract tumors. Cancer. 1991; 68:2561-5.

18. Reviewers’ comments (personal observations) on bladder cancer.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:770-2.

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