FOSCARNET SODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CMV Retinitis 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. Mucocutaneous Acyclovir Resistant HSV Infections 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, 6000 mg/250 mL (24 mg/mL) is clear, colorless solution. It is available as follows: Strength Each Unit of Sale 6,000 mg/250 mL (24 mg/mL) NDC 70121-1744-1 1 Single-dose Intravenous Bag in an Overwrap NDC 70121-1744-7 Unit of 10 NDC 70121-1744-2 Unit of 12 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Single-dose. 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 its seal(s) 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. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.   Rev. 11-2023-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSCARNET SODIUM- FOSCARNET SODIUM INJECTION
AMNEAL PHARMACEUTICALS LLC
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FOSCARNET SODIUM INJECTION
6,000 MG/250 ML (24 MG/ML)
RX ONLY
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, USP is a white to almost white, crystalline powder
containing 6
equivalents of water of hydration with an empirical formula of Na CO
P.6H O and a
molecular weight of 300.04. 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, clear, colorless solution
for intravenous
administration only. 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.
3
5
2
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. Foscarnet does not require activation
(phosphorylation) by
thymidine k