gallium nitrate [IV]

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

Notes:

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

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of symptomatic cancer-related hypercalcemia unresponsive to adequate hydration

Contraindications ⬆ ⬇

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

Black Box Warnings ⬆ ⬇

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

Dosing Adjustment ⬆ ⬇

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

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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.

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇

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

Brands and Availability ⬆ ⬇