(GAL ee um NYE trate)
Treatment of symptomatic cancer-related hypercalcemia (refractory to adequate hydration)
Severe renal dysfunction (serum creatinine >2.5 mg/dL)
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Note: Initiate IV hydration prior to treatment; maintain throughout treatment.
Hypercalcemia (cancer-related): 200 mg/m2/day continuous infusion for 5 consecutive days; treatment duration may be shortened if normocalcemia is achieved in <5 days. If hypercalcemia is mild and with limited symptoms, 100 mg/m2/day may be used.
Refer to adult dosing.
Moderate renal impairment (serum creatinine 2 to ≤2.5 mg/dL): There are no dosage adjustment s provided in the manufacturer 's labeling; frequent monitoring of renal status is recommended.
Severe renal impairment (serum creatinine >2.5 mg/dL): Use is contraindicated.
Dilute in 1000 mL NS (preferred) or D5W for infusion.
The manufacturer recommends continuous IV infusion over 24 hours.
Store intact vials at room temperature of 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Dilute in 1000 mL NS (preferred) or D5W for infusion. Solutions in 0.9% NaCl or D5W are stable for 48 hours at room temperature or for 7 days under refrigeration at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Ganite: 25 mg/mL (20 mL [DSC])
Stable in NS, D5W.
Y-site administration: Incompatible with cefepime, cisplatin, cytarabine, doxorubicin, doxorubicin liposome, etoposide, haloperidol, hydromorphone, lorazepam, morphine.
Compatibility in syringe: Incompatible with ceftriaxone.
Aminoglycosides: May enhance the nephrotoxic effect of Gallium Nitrate. Avoid combination
Amphotericin B: May enhance the nephrotoxic effect of Gallium Nitrate. Avoid combination
Vancomycin: May enhance the nephrotoxic effect of Gallium Nitrate. Avoid combination
Renal function (BUN, serum creatinine); serum calcium (baseline, then daily); serum phosphorus (baseline, then twice weekly); albumin; fluid intake, urine output
Frequency not always defined.
Cardiovascular: Edema (lower extremity), hypotension, tachycardia
Central nervous system: Coma, confusion, dreams, encephalopathy, fever, hallucinations, hypothermia, lethargy
Dermatologic: Rash
Endocrine & metabolic: Hypophosphatemia ( ≤79%), serum bicarbonate decreased (40% to 50%), hypocalcemia (38%), respiratory alkalosis (mild)
Gastrointestinal: Constipation, diarrhea, nausea, vomiting
Hematologic: Anemia, leukopenia
Neuromuscular & skeletal: Paresthesia, positive Cvostek 's sign
Ocular: Optic neuritis (<1%), blindness (case report)
Otic: Auditory acuity decreased (<1%), tinnitus (<1%), hearing decreased
Renal: BUN increased (13%), creatinine increased (13%), acute renal failure
Respiratory: Dyspnea, pleural effusion, pulmonary infiltrates, rales, rhonchi
Concerns related to adverse effects:
- Hypocalcemia: Treatment may result in mild-to-moderate or asymptomatic hypocalcemia; may require discontinuation of gallium nitrate.
- Renal toxicity: [U.S. Boxed Warning]: Concurrent administration with other nephrotoxic drugs (eg, aminoglycosides, amphotericin B) may increase the risk for renal insufficiency in patients with cancer-related hypercalcemia; discontinue gallium nitrate during treatment with nephrotoxic drugs (monitor serum creatinine and urine output; continue hydration for several days). Discontinue with serum creatinine >2.5 mg/dL. BUN and serum creatinine elevations have been observed with gallium nitrate use; establish and maintain adequate hydration with oral and/or IV (normal saline) fluids; establish urinary output ≥2 L/day prior to treatment initiation.
Disease-related concerns:
- Cardiovascular disease: Use with caution in patients where aggressive hydration may be poorly tolerated, such as in cardiovascular disease (HF or hypertension) and pulmonary disease.
Concurrent drug therapy issues:
- Nephrotoxicity: Discontinue gallium nitrate during treatment with nephrotoxic drugs.
C
Reproduction studies have not been conducted. Gallium nitrate should be used in pregnant women only if clearly needed.
Inhibits calcium resorption from bone by inhibiting osteoclast activity. Gallium nitrate appears to be effective in parathyroid hormone-related protein (PTHrP) and non-PTHrP-associated hypercalcemia.
Continuous infusion: Vdss: 670 L/m2
Primarily renal with no prior metabolism in the liver or kidney
Onset of calcium lowering: Calcium begins to decrease within 24-48 hours; normocalcemia achieved within 5-9 days
Normocalcemia: 7-10 days
Continuous infusion: 105 hours
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience constipation, diarrhea, or nausea. Have patient report immediately to prescriber signs of renal impairment, signs of hypocalcemia, tachycardia, illogical thinking, nightmares, or hallucinations (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.