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Digoxin immune fab
Digoxin immune fab binds to and neutralizes circulating digoxin, preventing its toxic effects by forming inactive complexes that are renally eliminated.
Digoxin immune fab binds to and neutralizes circulating digoxin, preventing its toxic effects by forming inactive complexes that are renally eliminated. Used for Digoxin toxicity or overdose, Life-threatening digoxin toxicity with arrhythmias or hyperkalemia.
At a glance
| Generic name | Digoxin immune fab |
|---|---|
| Also known as | Digibind |
| Sponsor | National Institute on Aging (NIA) |
| Drug class | Antidote; Immunoglobulin fragment |
| Target | Digoxin (cardiac glycoside) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular; Toxicology |
| Phase | FDA-approved |
Mechanism of action
Digoxin immune fab consists of antigen-binding fragments derived from sheep antibodies raised against digoxin. These fragments have high affinity for digoxin and its metabolites, sequestering the drug in the bloodstream and preventing its interaction with Na+/K+-ATPase in cardiac and renal tissues. The digoxin-fab complexes are then eliminated via the kidneys, rapidly reversing digoxin toxicity.
Approved indications
- Digoxin toxicity or overdose
- Life-threatening digoxin toxicity with arrhythmias or hyperkalemia
Common side effects
- Hypokalemia
- Allergic reactions (rash, fever)
- Worsening heart failure (due to loss of digoxin inotropic effect)
- Serum sickness
Key clinical trials
- Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI (PHASE4)
- Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia (PHASE2, PHASE3)
- Marinobufagenin as a Target for DIGIBIND in Preeclampsia
- Efficacy Study of Digibind for Treatment of Severe Preeclampsia (PHASE2)
- Antibodies to Digoxin for Bipolar Disorder (PHASE2)
- Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Digoxin immune fab CI brief — competitive landscape report
- Digoxin immune fab updates RSS · CI watch RSS
- National Institute on Aging (NIA) portfolio CI