foscavir- 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:

AstraZeneca LP

INN (International Name):

Foscarnet Sodium

Pharmaceutical form:

INJECTION

Composition:

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 glass bottles as follows: NDC 0186-1906-01500 mL bottles, cases of 12 FOSCAVIR INJECTION should be stored at controlled room temperature, 15 − 30°C (59 − 86°F), and should be protected from excessive heat (above 40°C) and from freezing. FOSCAVIR INJECTION should be used only if the bottle and seal are intact, a vacuum is present, and the solution is clear and colorless. FOSCAVIR is a trademark of the AstraZeneca group of companies. AstraZeneca 2006 Manufactured For: AstraZeneca LP Wilmington, DE 19850 By: Hospira Inc., Lake Forest, IL 60045 USA 30620–xx Rev. 08/06

Summary of Product characteristics

FOSCAVIR- FOSCARNET SODIUM INJECTION
ASTRAZENECA LP
----------
FOSCAVIR®
(FOSCARNET SODIUM)
INJECTION
BOXED 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 AND USAGE 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 0 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 and/or
sodium hydroxide may have been added to adjust the pH of the solution
to 7.4. FOSCAVIR INJECTION
contains no preservatives.
VIROLOGY
MECHANISM OF ACTION:
FOSCAVIR is an organic analogue of inorganic pyrophosphate that
inhibits replication of
herpesviruses _in vitro_ including cytomegalovirus (CMV) and herpes
simplex virus types 1 and 2 (HSV-1
and HSV-2).
FOSCAVIR exerts its antiviral activity by a selective inhibition at
the pyrophosphate binding site on
virus-specific DNA polymerases at concent