Adult Dosing

Symptomatic cancer-related hypercalcemia

• 200 mg/m²/day IV x 5 days
• Mild hypercalcemia with few symptoms: 100 mg/m²/day IV x 5 days

• Discontinue the treatment early if serum calcium levels fall into the normal range in <5 days
• Should be administered as an intravenous infusion over 24 hrs
• Maintain adequate hydration throughout the treatment duration
• Dilute the calculated dose in 1000 mL of 0.9% sodium chloride injection or 5% dextrose injection and infuse over 24 hrs

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• Treatment of symptomatic cancer-related hypercalcemia unresponsive to adequate hydration

• Hypersensitivity to any of the ingredients of the product
• Severe renal impairment (serum creatinine >2.5 mg/dL)

• Risk of developing severe renal insufficiency may increase upon concurrent use of gallium nitrate with other potentially nephrotoxic drugs
• Discontinue gallium nitrate if use of a potentially nephrotoxic agent is recommended during gallium nitrate therapy and continue hydration for several days after administration of the potentially nephrotoxic drug. Monitor serum creatinine and urine output closely during and subsequent to this period
• Discontinue therapy if the serum creatinine level exceeds 2.5 mg/dL

Renal Dose Adjustment (Based on serum creatinine)

• Moderate impairment (2-2.5 mg/dL): Dose adjustments not defined; frequent monitoring is recommended
• Severe renal impairment (>2.5 mg/dL): Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Gallium nitrate use along with other potential nephrotoxic drugs is associated with an increased risk of developing severe renal insufficiency in patients with cancer-related hypercalcemia; discontinue therapy if serum creatinine level exceeds 2.5 mg/dL [US Black Box Warning]
• Hypercalcemia in cancer patients is usually associated with impaired renal function
• Frequent monitoring of the renal status is recommended in patients with moderate renal insufficiency (serum creatinine 2-2.5 mg/dL)
• Monitor renal functions (BUN and serum creatinine) and serum calcium during therapy; serum calcium and phosphorus should be measured daily and twice weekly respectively, in addition to baseline testing
• Patients must be adequately hydrated with oral and/or IV fluids (preferably saline), and a satisfactory urine output (2 L/day) should be established before beginning therapy. Maintain adequate hydration during treatment and avoid over-hydration in patients with compromised cardiovascular status
• Cases of asymptomatic or mild to moderate hypocalcemia have been reported during therapy. Gallium nitrate should be stopped in such cases and short term-calcium therapy may be administered

Pregnancy Category:C

Breastfeeding: According to the manufacturer's data, due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, analyzing the importance of the drug to the mother.

• CNS: Confusion, abnormal dreams, hallucinations
• NEURO: Paresthesia
• CV: Tachycardia, edema, hypotension
• RESP: Dyspnea, rales and rhonchi, pleural effusion, pulmonary infiltrates
• GI: Nausea, vomiting, diarrhea, constipation
• HEMA: Anemia, leukopenia
• EENT: Optic neuritis, hearing impairment
• METABOLIC: Hypocalcemia, mild-moderate transient hypophosphatemia, decreased serum bicarbonate concentrations
• DERM: Skin rash
• GU: Acute renal failure, renal impairment
• LABTESTS: Increase in BUN and creatinine
• MISC: Lethargy, hypothermia, fever

• Hypocalcemic agent; exact mechanism of action unknown; inhibits calcium resorption from bone, possibly by reducing increased bone turnover
• Not metabolized by the liver or the kidney
• Renally excreted
• Half-life: Unknown

US Trade Name(s)

• Ganite

US Availability

Ganite

• INJ: 25 mg/mL (20 mL vials)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Hypocalcemics

Bone Resorption Inhibitor