Drug information of Gallium Nitrate

Gallium Nitrate

Drug group:

 this drug 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.

Pharmacokinetics

Serum Concentrations:
Steady state reached in 24–48 hours.
Metabolism:
Not metabolized by liver or kidneys. 
Elimination Route:
Substantially excreted by kidneys. Average plasma clearance: 0.15 L/hour per kg. 

Drug indications

Hypercalcemia
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.

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

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.

Drug contraindications

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

Side effects

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

amikacin liposome ,  amphotericin b cholesteryl sulfate , amphotericin b lipid complex , immune globulin intravenous , immune globulin intravenous and subcutaneous  ,  respiratory syncytial virus immune globulin , rho (d) immune globulin 

Alerts

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).
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.

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.1 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.)
 
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.

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.

Points of recommendation

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

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

-Administer by slow IV infusion over 24 hours.


- 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

-torage
Injection:
20–25°C
Stable for 48 hours at 15–30°C or for 7 days at 2–8°C when diluted as recommended.

Pregnancy level

C

 

Breast feeding warning

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

Drug forms

Ganite

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