FOSCAVIR (foscarnet sodium)
Foscavir is an antiviral medication used for patients with AIDS who have developed CMV retinitis. It also helps immunocompromised patients who have mucocutaneous HSV infections that no longer respond to acyclovir. In cases where patients have relapsed after initial single-drug therapy, this medication can be used in combination with ganciclovir.
How FOSCAVIR Works
This medication works by selectively blocking the pyrophosphate binding site on viral DNA polymerases. Because it does not require activation by viral or cellular enzymes, it can directly inhibit the virus's ability to replicate without affecting the patient's own DNA polymerases.
Details
- Status
- Prescription
- First Approved
- 1991-09-27
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FOSCAVIR Approval History
What FOSCAVIR Treats
3 indicationsFOSCAVIR is approved for 3 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Acquired Immunodeficiency Syndrome
- Acyclovir-Resistant Herpes Simplex Virus Infections
FOSCAVIR Boxed Warning
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 ...
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).
FOSCAVIR 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.
Drugs Similar to FOSCAVIR
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
FOSCAVIR FDA Label Details
Indications & Usage
FDA Label (PDF)FOSCAVIR is indicated for the treatment of Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome; Acyclovir-Resistant Herpes Simplex Virus Infections.
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.