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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.)
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FOSCARNET SUMMARY
FOSCARNET SODIUM INJECTION
The chemical name of foscarnet sodium is phosphonoformic acid, trisodium salt.
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 and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NON-IMMUNOCOMPROMISED 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 HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NON-IMMUNOCOMPROMISED INDIVIDUALS.
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NEWS HIGHLIGHTS
Published Studies Related to Foscarnet
Antiviral therapeutic efficacy of foscarnet in hepatitis B virus infection. [2005.12]
Foscarnet (PFA), a viral DNA polymerase inhibitor, is a clinical agent for herpes viruses. The goal of the study was to evaluate the therapeutic efficacy of PFA in hepatitis B virus (HBV) infection.
Clinical Trials Related to Foscarnet
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) [Completed]
To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium
(Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate
the timing and volume of oral fluid hydration required to establish a diuresis before and
during intravenous Foscavir therapy. To assess the general tolerance of two hydration
regimens by the adverse event profile associated with each.
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease [Completed]
PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV)
gastrointestinal disease following foscarnet induction therapy only versus induction plus
maintenance therapy.
SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms,
response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in
this patient population.
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients [Completed]
To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS
patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the
safety and efficacy of three different foscarnet maintenance therapy regimens. To determine
the pharmacokinetics of intermittent administration of foscarnet with or without concomitant
administration of zidovudine (AZT).
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir [Completed]
To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS
patients who have herpes simplex virus infections that are resistant to standard treatment
with acyclovir.
Foscarnet is a drug that inhibits viruses and has been shown to be effective against
infection with Cytomegalovirus and also against infection with the Herpes simplex virus in
several patients with AIDS. Vidarabine has been shown to have activity against the Herpes
simplex virus in patients who do not have AIDS, but it has not been studied in patients who
do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who
have herpes simplex infection that has not responded to therapy with acyclovir in the hope
that one of these two drugs will help to stop further progression of the herpes simplex
infection and may have fewer side effects.
An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies [Completed]
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Page last updated: 2006-11-04
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