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GANITE
Overview
What is GANITE?
Gallium nitrate injection is a clear, colorless, odorless, sterile solution of gallium nitrate, a hydrated nitrate salt of the group IIIa element, gallium. Gallium nitrate is formed by the reaction of elemental gallium with nitric acid, followed by crystallization of the drug from the solution. The stable, nonahydrate, Ga(N0)•9HO is a white, slightly hygroscopic, crystalline powder of molecular weight 417.87, that is readily soluble in water. Each mL of Ganite (gallium nitrate injection) contains gallium nitrate 25 mg (on an anhydrous basis) and sodium citrate dihydrate 28.75 mg. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment to 6.0-7.0.
What does GANITE look like?
What are the available doses of GANITE?
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What should I talk to my health care provider before I take GANITE?
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How should I use GANITE?
Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.
The usual recommended dose of Ganite is 200 mg per square meter of body surface area (200 mg/m) daily for 5 consecutive days. In patients with mild hypercalcemia and few symptoms, a lower dosage of 100 mg/m/day for 5 days may be considered. If serum calcium levels are lowered into the normal range in less than 5 days, treatment may be discontinued early. The daily dose must be administered as an intravenous infusion over 24 hours. The daily dose should be diluted, preferably in 1,000 mL of 0.9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP, for administration as an intravenous infusion over 24 hours. Adequate hydration must be maintained throughout the treatment period, with careful attention to avoid overhydration in patients with compromised cardiovascular status. Controlled studies have not been undertaken to evaluate the safety and effectiveness of retreatment with gallium nitrate.
When Ganite is added to either 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP, it is stable for 48 hours at room temperature (15°C to 30°C) or for 7 days if stored under refrigeration (2°C to 8°C). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
What interacts with GANITE?
Ganite should not be administered to patients with severe renal impairment (serum creatinine > 2.5 mg/dL).
What are the warnings of GANITE?
Array
(See boxed .) The hypercalcemic state in cancer patients is commonly associated with impaired renal function. Abnormalities in renal function (elevated BUN and/or serum creatinine) have been observed in clinical trials with Ganite. Since patients with cancer-related hypercalcemia are frequently dehydrated, it is important that such patients be adequately hydrated with oral and/or intravenous fluids (preferably saline) and that a satisfactory urine output (a urine output of 2 L/day is recommended) be established before therapy with Ganite is started. Adequate hydration should be maintained throughout the treatment period, with careful attention to avoid overhydration in patients with compromised cardiovascular status. Diuretic therapy should not be employed prior to correction of hypovolemia. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
The use of Ganite in patients with marked renal insufficiency (serum creatinine > 2.5 mg/dL) has not been systematically examined. If therapy is undertaken in patients with moderately impaired renal function (serum creatinine 2.0 to 2.5 mg/dL), frequent monitoring of the patient’s renal status is recommended. Treatment should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
Combined use of Ganite with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk of developing renal insufficiency in patients with cancer-related hypercalcemia (see boxed ).
What are the precautions of GANITE?
General
Laboratory Tests
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy Category C
Nursing Mothers
Pediatric Use
What are the side effects of GANITE?
Kidney
Metabolic
Transient hypophosphatemia of mild-to-moderate degree may occur in up to 79% of hypercalcemic patients following treatment with Ganite. In a controlled clinical trial, 33% of patients had at least 1 serum phosphorus measurement between 1.5-2.4 mg/dL, while 46% of patients had at least 1 serum phosphorus value <1.5 mg/dL. Patients who develop hypophosphatemia may require oral phosphorus therapy.
Decreased serum bicarbonate, possibly secondary to mild respiratory alkalosis was reported in 40-50% of cancer patients treated with Ganite. The cause for this effect is not clear. This effect has been asymptomatic and has not required specific treatment.
Hematologic
Blood Pressure
Visual and Auditory
Miscellaneous
What should I look out for while using GANITE?
Ganite should not be administered to patients with severe renal impairment (serum creatinine > 2.5 mg/dL).
(See boxed .) The hypercalcemic state in cancer patients is commonly associated with impaired renal function. Abnormalities in renal function (elevated BUN and/or serum creatinine) have been observed in clinical trials with Ganite. Since patients with cancer-related hypercalcemia are frequently dehydrated, it is important that such patients be adequately hydrated with oral and/or intravenous fluids (preferably saline) and that a satisfactory urine output (a urine output of 2 L/day is recommended) be established before therapy with Ganite is started. Adequate hydration should be maintained throughout the treatment period, with careful attention to avoid overhydration in patients with compromised cardiovascular status. Diuretic therapy should not be employed prior to correction of hypovolemia. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
The use of Ganite in patients with marked renal insufficiency (serum creatinine > 2.5 mg/dL) has not been systematically examined. If therapy is undertaken in patients with moderately impaired renal function (serum creatinine 2.0 to 2.5 mg/dL), frequent monitoring of the patient’s renal status is recommended. Treatment should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
Combined use of Ganite with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk of developing renal insufficiency in patients with cancer-related hypercalcemia (see boxed ).
What might happen if I take too much GANITE?
Rapid intravenous infusion of gallium nitrate or use of doses higher than recommended (200 mg/m) may cause nausea and vomiting and a substantially increased risk of renal insufficiency. In the event of overdosage, further drug administration should be discontinued, serum calcium should be monitored, and the patient should receive vigorous intravenous hydration, with or without diuretics, for 2-3 days. During this time period, renal function and urinary output should be carefully monitored so that fluid intake and output are balanced.
How should I store and handle GANITE?
Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05.Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL.Store at controlled room temperature 20°-25°C (68°-77°F).Contains no preservative. Discard unused portion.Rx onlyGanite® is a trademark of Genta Incorporated.Manufactured for:Genta IncorporatedBerkeley Heights, NJ 079221-888-TO-GENTARevised: October 200630105902
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
in vitro
Pharmacokinetics
Cancer-Related Hypercalcemia
Hypercalcemia may produce a spectrum of signs and symptoms including: anorexia, lethargy, fatigue, nausea, vomiting, constipation, dehydration, renal insufficiency, impaired mental status, coma and cardiac arrest. A rapid rise in serum calcium may cause more severe symptoms for a given level of hypercalcemia. Since calcium is bound to serum proteins, which may fluctuate in concentration as a response to changes in blood volume, changes in total serum calcium (especially during rehydration) may not accurately reflect changes in the concentration of free-ionized calcium. In the absence of a direct measurement of free-ionized calcium, measurement of the serum albumin concentration and correction of the total serum calcium concentration may help in assessing the severity of hypercalcemia. The patient’s acid-base status should also be taken into consideration while assessing the degree of hypercalcemia. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). The patient’s cardiovascular status should be taken into consideration in the use of saline. In patients who have an underlying cancer type that may be sensitive to corticosteroids (e.g., hematologic cancers), the use or addition of corticosteroid therapy may be indicated.
Hypocalcemic Activity
The median duration of normocalcemia/hypocalcemia was 7.5 days for patients treated with Ganite and 1 day for patients treated with calcitonin. A total of 92% of patients treated with Ganite had a decrease in serum calcium (corrected for albumin) ≥ 2.0 mg/dL as compared to 54% of the patients treated with calcitonin (p=0.004).
An open-label, non-randomized study was conducted to examine a range of doses and dosing schedules of Ganite for control of cancer-related hypercalcemia. The principal dosing regimens were 100 and 200 mg/m/day, administered as continuous intravenous infusions for 5 days. Ganite, at a dose of 200 mg/m/day for 5 days was found to normalize elevated serum calcium levels (corrected for albumin) in 83% of patients as compared to 50% of patients receiving a dose of 100 mg/m/day for 5 days. A decrease in serum calcium (corrected for albumin) ≥ 2.0 mg/dL was observed in 83% and 94% of patients treated with Ganite at dosages of 100 and 200 mg/m/day for 5 days, respectively. There were no significant differences in the proportion of patients responding to Ganite when considering either the presence or absence of bone metastasis, or whether the tumor histology was epidermoid or nonepidermoid.
Non-Clinical Toxicology
Ganite should not be administered to patients with severe renal impairment (serum creatinine > 2.5 mg/dL).(See boxed .) The hypercalcemic state in cancer patients is commonly associated with impaired renal function. Abnormalities in renal function (elevated BUN and/or serum creatinine) have been observed in clinical trials with Ganite. Since patients with cancer-related hypercalcemia are frequently dehydrated, it is important that such patients be adequately hydrated with oral and/or intravenous fluids (preferably saline) and that a satisfactory urine output (a urine output of 2 L/day is recommended) be established before therapy with Ganite is started. Adequate hydration should be maintained throughout the treatment period, with careful attention to avoid overhydration in patients with compromised cardiovascular status. Diuretic therapy should not be employed prior to correction of hypovolemia. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
The use of Ganite in patients with marked renal insufficiency (serum creatinine > 2.5 mg/dL) has not been systematically examined. If therapy is undertaken in patients with moderately impaired renal function (serum creatinine 2.0 to 2.5 mg/dL), frequent monitoring of the patient’s renal status is recommended. Treatment should be discontinued if the serum creatinine level exceeds 2.5 mg/dL.
Combined use of Ganite with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk of developing renal insufficiency in patients with cancer-related hypercalcemia (see boxed ).
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to SYNTHROID. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
General
Laboratory Tests
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy Category C
Nursing Mothers
Pediatric Use
Kidney
Metabolic
Transient hypophosphatemia of mild-to-moderate degree may occur in up to 79% of hypercalcemic patients following treatment with Ganite. In a controlled clinical trial, 33% of patients had at least 1 serum phosphorus measurement between 1.5-2.4 mg/dL, while 46% of patients had at least 1 serum phosphorus value <1.5 mg/dL. Patients who develop hypophosphatemia may require oral phosphorus therapy.
Decreased serum bicarbonate, possibly secondary to mild respiratory alkalosis was reported in 40-50% of cancer patients treated with Ganite. The cause for this effect is not clear. This effect has been asymptomatic and has not required specific treatment.
Hematologic
Blood Pressure
Visual and Auditory
Miscellaneous
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
Interactions
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