GANITE- gallium nitrate injection, solution, concentrate

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

GALLIUM NITRATE (UNII: VRA0C6810N) (Gallium cation - UNII:F7K5MP217W)

Dostupné z:

Genta Incorporated

INN (Medzinárodný Name):

GALLIUM NITRATE

Zloženie:

GALLIUM NITRATE 25 mg in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. Ganite should not be administered to patients with severe renal impairment (serum creatinine > 2.5 mg/dL).

Prehľad produktov:

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 only Ganite® is a trademark of Genta Incorporated. Manufactured for: Genta Incorporated Berkeley Heights, NJ 07922 1-888-TO-GENTA Revised: October 2006 30105902

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

GANITE- GALLIUM NITRATE INJECTION, SOLUTION, CONCENTRATE
GENTA INCORPORATED
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GANITE® (GALLIUM NITRATE INJECTION)
WARNING
Concurrent use of gallium nitrate with other potentially nephrotoxic
drugs (e.g., aminoglycosides,
amphotericin B) may increase the risk for developing severe renal
insufficiency in patients with
cancer-related hypercalcemia. If use of a potentially nephrotoxic drug
is indicated during gallium
nitrate therapy, gallium nitrate administration should be discontinued
and it is recommended that
hydration be continued for several days after administration of the
potentially nephrotoxic drug.
Serum creatinine and urine output should be closely monitored during
and subsequent to this
period. Ganite therapy should be discontinued if the serum creatinine
level exceeds 2.5 mg/dL.
DESCRIPTION
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 ) •9H O 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.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_ Ganite exerts a hypocalcemic effect by
inhibiting calcium resorption from bone,
possibly by reducing increased bone turnover. Although _in vitro_ and
animal studies have been performed
to investigate the mechanism of action of gallium nitrate, the precise
mechanism for inhibiting calcium
resorption has not been determined. No cytotoxic effects were observed
on bone cells in drug-treated
animals.
_PHARMACOKINETICS_ Gallium nitrate was infused at a daily dose of 200
mg/m for 5 (n=2) or 7 (n=10)