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Gallium Nitrate

Pronouncation: (GAL-ee-uhm NYE-trate)
Class: Hypocalcemic agent

Trade Names:
Ganite
- Injection 25 mg/mL

Pharmacology

Exerts hypocalcemic effect by inhibiting calcium resorption from bone, possibly by stabilizing bone matrix, thereby reducing increased bone turnover.

Pharmacokinetics

Absorption

Steady state is achieved in 24 to 48 h.

Distribution

Vd is 1.27 L/kg.

Elimination

Plasma Cl is 0.12 to 0.2ߙL/h/kg. The t _½ is 24 to 115 h. Major route of elimination is kidney.

Duration

Median is 6 to 8 days.

Indications and Usage

Treatment of symptomatic, cancer-related hypercalcemia unresponsive to adequate hydration.

Contraindications

Severe renal impairment (serum creatinine more than 2.5ߙmg/dL).

Dosage and Administration

Adults

IV 100 to 200 mg/m ² /day for 5 consecutive days.

General Advice

For IV infusion only. Not for IV bolus, intradermal, subcutaneous, IM, or intra-arterial administration.
Dilute prescribed dose in 1 L sodium chloride 0.9% injection or dextrose 5% injection.
Infuse over 24 h using infusion control device.
Do not administer if particulate matter or cloudiness is noted.
Discard unused portions of vial. Do not save any unused portions for future use.

Storage/Stability

Store unopened vials at controlled room temperature (68° to 77°F). Diluted solutions can be stored for up to 48 h at ambient room temperature (59° to 86°F) or 7 days if stored under refrigeration (36° to 46°F).

Drug Interactions

Nephrotoxic drugs (eg, aminoglycosides, amphotericin B)

May increase risk for development of renal function impairment.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia; lower extremity edema; asymptomatic hypotension.

CNS

Lethargy, confusion, dreams, hallucinations, paresthesia.

EENT

Acute optic neuritis; visual impairment; tinnitus; decreased hearing.

GI

Nausea or vomiting; diarrhea; constipation.

Genitourinary

Increased BUN and creatinine (13%); acute renal failure.

Hematologic

Anemia; leukopenia.

Metabolic

Mild to moderate transient hypophosphatemia (79%); decreased serum bicarbonate concentrations (50%); hypocalcemia.

Respiratory

Shortness of breath; rales and rhonchi; pleural effusion; pulmonary infiltrates.

Miscellaneous

Hypothermia; fever; skin rash.

Precautions

Warnings

Concomitant use of gallium nitrate and potentially nephrotoxic drugs (eg, aminoglycosides, amphotericin B) may increase the risk for developing severe renal function impairment in patients with cancer-related hypocalcemia. If use of potentially nephrotoxic drugs is indicated, discontinue gallium and continue hydration for several days after administration of the potentially nephrotoxic agent.

Monitor

Calcium/Phosphorous

During therapy, ensure that serum calcium and phosphorous is determined before starting therapy and then daily for calcium, and twice weekly for phosphorous. If direct measurement of free-ionized calcium is not available, measure serum albumin concentration and correct serum calcium.

Hypercalcemia symptoms

Frequently assess patient for signs or symptoms of hypercalcemia (eg, anorexia, lethargy, fatigue, nausea, vomiting, constipation, impaired mental status) and hypocalcemia (eg, muscle cramps, positive Chvostek or Trousseau sign, paraesthesia of lips or extremities). Be prepared to discontinue gallium infusion and administer calcium supplement if hypocalcemia develops.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Hypercalcemia in cancer patients is commonly associated with impaired renal function. Evaluate renal function (BUN, creatinine) before starting therapy and frequently during therapy.

Asymptomatic or mild to moderate hypocalcemia

Occurs frequently.

Hydration

Ensure that patient is adequately hydrated using oral and/or IV fluids (preferably saline) and that a satisfactory urine output (eg, 2 L/day) is established before beginning therapy. Ensure that adequate hydration is maintained during therapy but avoid overhydration in patient with compromised CV function.

Visual and auditory disturbances

Acute optic neuritis and decreased hearing have occurred in some patients treated with multiple high doses of gallium combined with investigational anticancer drugs.

Overdosage

Symptoms

Nausea, vomiting, renal function impairment.

Patient Information

Advise patient or caregiver that medication will be prepared and administered by health care provider in a health care setting.
Review dosing schedule with patient or caregiver.
Advise patient to report any of the following to health care provider: abnormal dreams, chills, difficulty breathing, fast heartbeat, hallucinations, change in vision or hearing, weakness, mouth sores, muscle cramps or spasms, numbness or tingling around lips, abnormal skin sensations, confusion, constipation or diarrhea, swelling of ankles or feet, nausea, vomiting, rash.