Risk of severe renal insufficiency in patients with cancer-related hypercalcemia when administered concomitantly with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B).
Discontinue gallium if use of a potentially nephrotoxic drug is indicated; continue hydration for several days after administration of the nephrotoxic drug. Closely monitor Scr and urine output during and after this period. If Scr exceeds 2.5 mg/dL, discontinue gallium therapy.
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); designated an orphan drug by FDA for this use.
More conservative measures than gallium therapy (e.g., hydration alone or combined with diuretics) generally are used for mild or asymptomatic hypercalcemia.
Bladder Cancer
Has been used alone and in combination with other antineoplastic agents for the treatment of advanced or metastatic bladder carcinoma†; however, other agents are preferred.
Dosage and Administration
General
Hypercalcemia
Prior to initiating therapy, establish adequate hydration and urinary output in order to increase renal excretion of calcium.
For solution and drug compatibility information, see Compatibility under Stability.
Administer by slow IV infusion.
Dilution
Dilute calculated daily dose, preferably in 1 L of 0.9% sodium chloride injection or 5% dextrose injection. Discard unused portion of vial.
Rate of Administration
Administer by slow IV infusion over 24 hours.
Dosage
Adults
Hypercalcemia
IV
200 mg/m2 daily for 5 consecutive days.
If used for mild hypercalcemia and few associated symptoms, 100 mg/m2 daily for 5 days may be used.
If optimum serum calcium concentrations are achieved in <5 days, therapy may be discontinued early.
Prescribing Limits
Adults
Hypercalcemia
IV
Safety and efficacy of repeated courses not established.
Special Populations
Renal Impairment
Hypercalcemia
IV
Contraindicated in patients with severe renal impairment (Scr >2.5 mg/dL).
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. (See Renal Impairment under Cautions.)
Cautions
Contraindications
Severe renal impairment (Scr >2.5 mg/dL).
Warnings/Precautions
Warnings
Renal Effects
Renal function abnormalities reported in clinical trials with gallium; hypercalcemia in cancer patients is commonly associated with impaired renal function.
Establish adequate hydration and satisfactory urine output (e.g., 2 L daily) before initiating therapy. Maintain adequate hydration throughout treatment period. Avoid overhydration in patients with compromised cardiovascular status.
Monitoring of Scr during gallium therapy is strongly recommended. Discontinue gallium if Scr >2.5 mg/dL.
Concomitant use of gallium with other nephrotoxic drugs may increase the risk of renal insufficiency in patients with cancer-related hypercalcemia. (See Boxed Warning.)
General Precautions
Hypocalcemia
Asymptomatic or mild to moderate hypocalcemia (6.5–8 mg/dL, corrected for albumin) may occur. Manufacturer recommends daily monitoring of serum calcium concentrations. If hypocalcemia occurs, discontinue gallium; short-term calcium replacement may be necessary.
Hypophosphatemia
Transient hypophosphatemia may occur. Manufacturer recommends twice-weekly monitoring of serum phosphorus concentrations.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether gallium is distributed into milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Renal Impairment
Contraindicated in patients with Scr >2.5 mg/dL. Safety and efficacy in these patients have not been examined systematically.
If used in patients with Scr of 2–2.5 mg/dL, monitor renal function frequently. Discontinue if Scr increases beyond 2.5 mg/dL.
Common Adverse Effects
Increased BUN and Scr, hypocalcemia, transient hypophosphatemia, decreased serum bicarbonate, decreased BP.
Interactions
Nephrotoxic Drugs
Potential increased risk of nephrotoxicity. Discontinue gallium if use of a potentially nephrotoxic drug is indicated; continue hydration for several days after administration of the nephrotoxic drug. Closely monitor Scr and urine output during and after this period. If Scr >2.5 mg/dL, discontinue gallium therapy.
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 prednisone
Exerts hypocalcemic effect by inhibiting calcium resorption from bone, possibly by reducing increased bone turnover.
No cytotoxic effects were seen on bone cells of animals treated with gallium.
Advice to Patients
Risk of renal function abnormalities, hypocalcemia, and transient hypophosphatemia. Importance of laboratory monitoring.
Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
Sign up with Facebook
