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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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 and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJETION 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 glass bottles containing 6,000 mg foscarnet sodium (24 mg/mL) as follows: NDC 23155-771-31 250 mL bottle NDC 23155-771-41 250 mL bottles, cases of 10 Single-dose. Discard unused portion. Store at 20˚to 25˚C (68˚to 77˚F), excursions permitted between 15˚to 30˚C (59˚to 86˚F) [see USP Controlled Room Temperature]. 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 bottle at room temperature with repeated shaking, the precipitate can be brought into solution again. Foscarnet sodium injection should be used only if the bottle and seal are intact, a vacuum is present, and the solution is clear and colorless. Manufactured by: Siegfried Hameln GmbH Langes Feld 13, Hameln, 31789, Lower Saxony, Germany (DEU) Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 03/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSCARNET SODIUM- FOSCARNET SODIUM INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
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,
hexahydrate. Foscarnet sodium is a white to almost white, crystalline
powder containing
6 equivalents of water of hydration with an empirical formula of Na CO
P•6 H O and a
molecular weight of 300.04. The structural formula is:
Foscarnet sodium 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.
3
5
2
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. Foscarnet does not require activation
(