FERUMOXYTOL
Details
- Status
- Prescription
- First Approved
- 2021-01-15
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FERUMOXYTOL Approval History
What FERUMOXYTOL Treats
2 indicationsFERUMOXYTOL is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency Anemia
- Chronic Kidney Disease
FERUMOXYTOL Boxed Warning
RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warn...
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions ( 5.1 ) ]. • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration [see Warnings and Precautions ( 5.1 ) ]. • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated [see Warnings and Precautions ( 5.1 ) ] . WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning. Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. ( 5.1 ) • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration. ( 5.1 ) • Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated. ( 5.1 )
Drugs Similar to FERUMOXYTOL
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
FERUMOXYTOL FDA Label Details
ProIndications & Usage
Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD).
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Only administe...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.