Country: United States
Language: English
Source: NLM (National Library of Medicine)
foscarnet sodium (UNII: 964YS0OOG1) (foscarnet - UNII:364P9RVW4X)
Clinigen Limited
INTRAVENOUS
PRESCRIPTION DRUG
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.
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 76310-024-15 250 mL bottle NDC 76310-024-25 250 mL bottles, cases of 10 NDC 76310-024-41 250 mL infusion bag NDC 76310-024-45 250 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
New Drug Application
FOSCAVIR- FOSCARNET SODIUM INJECTION, SOLUTION CLINIGEN LIMITED ---------- 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 Read the complete document