FOSCARNET SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOSCARNET SODIUM (UNII: 964YS0OOG1) (FOSCARNET - UNII:364P9RVW4X)

Available from:

Baxter Healthcare Corporation

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Foscarnet sodium injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with foscarnet sodium Injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS. Foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS. Foscarnet sodium injection is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

Product summary:

Foscarnet sodium injection, 24 mg/mL for intravenous infusion, is supplied in 250 mL dual port infusion bag containing 6,000 mg foscarnet sodium (24 mg/mL) as follows: NDC Foscarnet Sodium Injection (24 mg per mL) Package Factor 43066-089-10 6,000 mg per 250 mL Single-Dose Infusion Bag 10 bags per carton Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. For Single Dose Only. Discard unused portion. Protect from excessive heat (above 40°C) and from freezing. If refrigerated or exposed to temperatures below the freezing point, precipitation may occur. By keeping the infusion bag at room temperature with repeated shaking, the precipitate can be brought into solution again. Foscarnet sodium injection should be used only if the infusion bag and twist off port stopper are intact, a vacuum is present, and the solution is clear and colorless. Do not remove the infusion bag from the overwrap until ready for use. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSCARNET SODIUM- FOSCARNET SODIUM INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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FOSCARNET SODIUM INJECTION
(FOR CENTRAL INTRAVENOUS INFUSION ONLY.
MUST BE DILUTED FOR PERIPHERAL INTRAVENOUS INFUSION)
WARNING
RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCARNET SODIUM
INJECTION. FREQUENT MONITORING OF SERUM CREATININE, WITH DOSE
ADJUSTMENT FOR CHANGES IN RENAL FUNCTION, AND ADEQUATE
HYDRATION WITH ADMINISTRATION OF FOSCARNET SODIUM INJECTION
IS IMPERATIVE. (SEE ADMINISTRATION SECTION; HYDRATION.)
SEIZURES, RELATED TO ALTERATIONS IN PLASMA MINERALS AND
ELECTROLYTES, HAVE BEEN ASSOCIATED WITH FOSCARNET SODIUM
INJECTION TREATMENT. THEREFORE, PATIENTS MUST BE CAREFULLY
MONITORED FOR SUCH CHANGES AND THEIR POTENTIAL SEQUELAE.
MINERAL AND ELECTROLYTE SUPPLEMENTATION MAY BE REQUIRED.
FOSCARNET SODIUM INJECTION IS INDICATED FOR USE ONLY IN
IMMUNOCOMPROMISED PATIENTS WITH CMV RETINITIS AND
MUCOCUTANEOUS ACYCLOVIR‑RESISTANT HSV INFECTIONS. (SEE
INDICATIONS SECTION).
DESCRIPTION
The chemical name of foscarnet sodium is phosphonoformic acid,
trisodium salt.
Foscarnet sodium is a white, crystalline powder containing 6
equivalents of water of
hydration with an empirical formula of Na3CO5P·6H2O and a molecular
weight of 300.1.
The structural formula is:
Foscarnet sodium injection has the potential to chelate divalent metal
ions, such as
calcium and magnesium, to form stable coordination compounds.
Foscarnet sodium
injection is a sterile, isotonic aqueous solution for intravenous
administration only. The
solution is clear and colorless. Each milliliter of foscarnet sodium
Injection contains 24
mg of foscarnet sodium hexahydrate in Water for Injection, USP.
Hydrochloric acid may
have been added to adjust the pH of the solution to 7.4. Foscarnet
sodium injection
contains no preservatives.
VIROLOGY
MECHANISM OF ACTION
Foscarnet exerts its antiviral activity by a selective inhibition at
the pyrophosphate
binding site on virus-specific DNA polymerases at concentrations that
do not affect
cellular DNA polymerases. Fos