INFED (iron dextran)
INFED is indicated for the treatment of Iron Deficiency.
How INFED Works
Following administration, iron is released from the iron dextran complex into the circulation. This released iron, which remains subject to physiological regulatory mechanisms, is utilized to replenish depleted body iron stores and facilitate the synthesis of hemoglobin.
Details
- Status
- Prescription
- First Approved
- 1974-04-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
INFED Approval History
What INFED Treats
1 indicationsINFED is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Iron Deficiency
INFED Boxed Warning
RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full the...
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS See full prescribing information for complete boxed warning. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. ( 5.1 ) Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laborato
INFED Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05167734 PABST-BR results posted | 21-006511 K23HL153310-01 | Ph 2 | completed | Practical Anemia Bundle for SusTained Blood Recovery |
| NCT05960227 | HCG | Ph 2 | completed | Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury |
| NCT03438227 IVIDA results posted | 1809251633 | Ph 4 | completed | Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial |
| NCT05047211 IVIRONMAN results posted | 21-0127 | Ph 4 | completed | Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia |
| NCT00704028 results posted | 1VIT08020 | Ph 3 | completed | Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia |
| NCT03212781 | IDAO | Ph 3 | completed | Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women |
| NCT00593619 | HSREB13767 | Ph 4 | suspended | Trial Comparing the Safety of Two Different Intravenous Iron Formulations |
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.
INFED FDA Label Details
Indications & Usage
FDA Label (PDF)INFED is indicated for the treatment of Iron Deficiency.
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions read...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.