FOSCARNET SODIUM · AMNEAL
Foscarnet sodium helps patients with AIDS who develop CMV retinitis, a viral infection that affects the eyes. It is used as a standalone therapy or in combination with ganciclovir for those who have relapsed after earlier treatments. This medication also treats herpes simplex virus (HSV) infections of the skin and mucous membranes in immunocompromised patients when the virus has become resistant to acyclovir.
How FOSCARNET SODIUM Works
This drug works by selectively blocking the pyrophosphate binding site on viral DNA polymerases, which prevents the virus from replicating. It is unique because it does not require activation by enzymes like thymidine kinase and specifically targets viral processes without interfering with the patient's own cellular DNA production.
Details
- Status
- Prescription
- First Approved
- 1991-09-27
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FOSCARNET SODIUM Approval History
What FOSCARNET SODIUM Treats
2 indicationsFOSCARNET SODIUM is approved for 2 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Herpes Simplex Virus Infection
FOSCARNET SODIUM Boxed Warning
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 ...
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).
FOSCARNET SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02151240 Focus-101 | cttq-focus-101 | Ph 4 | completed | Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOSCARNET SODIUM FDA Label Details
Indications & Usage
INDICATIONS 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 injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS. Mucocutaneous Acyclovir Resistant HSV Infections Foscarnet sodium ...
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 .)...
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FOSCAVIR
Full clinical data, patents, trials, and competitive landscape for foscarnet sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.