FOSCAVIR- 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:

Clinigen Limited

INN (International Name):

foscarnet sodium

Composition:

foscarnet sodium 24 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

FOSCAVIR (foscarnet sodium) INJECTION, 24 mg/mL for intravenous infusion, is supplied in 250 mL glass bottles or polypropylene based infusion bags containing 6000 mg foscarnet sodium (24 mg/mL) as follows: NDC 76310-024-11 250 mL bottle NDC 76310-024-01 250 mL bottles, cases of 10 NDC 76310-024-31 250 mL infusion bag NDC 76310-024-35 250 mL infusion bag, cases of 10 Single-dose. Discard unused portion. Store between 20° and 25°C (68° and 77°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 or infusion bag at room temperature with repeated shaking, the precipitate can be brought into solution again. FOSCAVIR INJECTION should be used only if the bottle or 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. Manufactured for: Clinigen Healthcare Ltd., DE14 2WW, UK Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA FOSCAVIR is a trademark of Clinigen Healthcare Ltd. Date of revision: October 2020 Novaplus is a registered trademark of Vizient, Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

FOSCAVIR- FOSCARNET SODIUM INJECTION, SOLUTION
CLINIGEN LIMITED
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FOSCAVIR
_(FOSCARNET SODIUM)_ INJECTION
WARNING
RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCAVIR. FREQUENT
MONITORING OF SERUM CREATININE, WITH DOSE ADJUSTMENT FOR
CHANGES IN RENAL FUNCTION, AND ADEQUATE HYDRATION WITH
ADMINISTRATION OF FOSCAVIR IS IMPERATIVE. (SEE ADMINISTRATION
SECTION; HYDRATION.)
SEIZURES, RELATED TO ALTERATIONS IN PLASMA MINERALS AND
ELECTROLYTES, HAVE BEEN ASSOCIATED WITH FOSCAVIR TREATMENT.
THEREFORE, PATIENTS MUST BE CAREFULLY MONITORED FOR SUCH
CHANGES AND THEIR POTENTIAL SEQUELAE. MINERAL AND ELECTROLYTE
SUPPLEMENTATION MAY BE REQUIRED.
FOSCAVIR IS INDICATED FOR USE ONLY IN IMMUNOCOMPROMISED
PATIENTS WITH CMV RETINITIS AND MUCOCUTANEOUS ACYCLOVIR-
RESISTANT HSV INFECTIONS. (SEE INDICATIONS SECTION).
DESCRIPTION
FOSCAVIR is the brand name for foscarnet sodium. 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
Na CO P•6 H O and a molecular weight of 300.1. The structural
formula is:
FOSCAVIR has the potential to chelate divalent metal ions, such as
calcium and
magnesium, to form stable coordination compounds. FOSCAVIR INJECTION
is a sterile,
isotonic aqueous solution for intravenous administration only. The
solution is clear and
colorless. Each milliliter of FOSCAVIR 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. FOSCAVIR INJECTION contains no preservatives.
VIROLOGY
MECHANISM OF ACTION
®
3
5
2
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 kinase or other kinases.
ANTIVIRAL ACTIVITY IN CELL CULTURE
The quantitative relationship between th