DIGIBIND SUMMARY
DIGIBIND, Digoxin Immune Fab (Ovine), is a sterile lyophilized powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin. Sheep are immunized with this material to produce antibodies specific for the antigenic determinants of the digoxin molecule. The antibody is then papain-digested and digoxin-specific Fab fragments of the antibody are isolated and purified by affinity chromatography.
DIGIBIND, Digoxin Immune Fab (Ovine), is indicated for treatment of potentially life-threatening digoxin intoxication.3 Although designed specifically to treat life-threatening digoxin overdose, it has also been used successfully to treat life-threatening digitoxin overdose.3 Since human experience is limited and the consequences of repeated exposures are unknown, DIGIBIND is not indicated for milder cases of digitalis toxicity.
Manifestations of life-threatening toxicity include severe ventricular arrhythmias such as ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhythmias such as severe sinus bradycardia or second or third degree heart block not responsive to atropine.
Ingestion of more than 10 mg of digoxin in previously healthy adults or 4 mg of digoxin in previously healthy children, or ingestion causing steady-state serum concentrations greater than 10 ng/mL, often results in cardiac arrest. Digitalis-induced progressive elevation of the serum potassium concentration also suggests imminent cardiac arrest. If the potassium concentration exceeds 5 mEq/L in the setting of severe digitalis intoxication, therapy with DIGIBIND is indicated.
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NEWS HIGHLIGHTS
Published Studies Related to Digibind (Digoxin Immune Fab)
The hemodynamic effects of intravenous digoxin-binding fab immunoglobulin in severe preeclampsia: a double-blind, randomized, clinical trial. [2009.04]
OBJECTIVE: An endogenous digitalis-like factor (EDLF) has been implicated in the pathophysiology of preeclampsia (PE). This hypothesis is supported by two cases of preeclampsia in which administration of digoxin immune Fab (DIF) reduced mean arterial pressure (MAP)... CONCLUSION: These results support the hypothesis that EDLF contributes to the elevated blood pressure in preeclampsia and suggests a possible role for DIF as a treatment for this condition.
The hemodynamic effects of intravenous digoxin-binding fab immunoglobulin in severe preeclampsia: a double-blind, randomized, clinical trial. [2009.01.15]
Objective:An endogenous digitalis-like factor (EDLF) has been implicated in the pathophysiology of preeclampsia (PE). This hypothesis is supported by two cases of preeclampsia in which administration of digoxin immune Fab (DIF) reduced mean arterial pressure (MAP).Study Design:To study this observation further, we performed a double-blind, placebo-controlled, randomized clinical trial to examine the effects on MAP of intravenous DIF given after delivery in 26 subjects with severe preeclampsia...
Prognostic utility of serum potassium in chronic digoxin toxicity: a case-control study. [2011.06.01]
OBJECTIVE: In contrast to patients with acute digoxin overdose, the prognostic utility of the serum potassium concentration for patients with chronic digoxin toxicity is unclear. In such patients, we aimed to evaluate the relationship between pre-treatment serum potassium and survival... CONCLUSION: In these patients with chronic digoxin toxicity, elevated serum potassium was associated with fatality. The combination of bradycardia and hyperkalemia strongly predicted fatality even in cases with appropriate Fab administration.
Rapid detection of oleander poisoning by Dimension Vista digoxin assay (Flex Reagent Cartridge). [2011]
Oleander poisoning can be detected by digoxin immunoassays and for last two decades the fluorescence polarization immunoassay (FPIA) has been used for rapid detection of oleander poisoning in clinical laboratories...
Treatment of chronically digoxin-poisoned patients with a newer digoxin immune fab--a retrospective study. [2010.10]
CONTEXT: Digoxin is used in the treatment of patients with cardiac dysfunction, though toxicity sometimes results from the use of this medication. In 1986, the US Food and Drug Administration (FDA) approved a digoxin immune Fab for the treatment of such patients. In 2001, the FDA approved a newer digoxin immune Fab, a digoxin-specific antibody (DSAb) known as DigiFab (Protherics Inc, Brentwood, Tennessee), though minimal literature exists on the clinical effects of this DSAb. OBJECTIVES: To characterize a cohort of patients presenting with chronic digoxin toxicity and to describe the clinical course of these patients with the use of DSAb... CONCLUSION: The newer DSAb appears to be a safe and effective treatment for resolving digoxin toxicity in adults, as indicated by electrocardiogram and clinical assessments. Because patients with multiple comorbidities may be at greater risk for digoxin toxicity, they should be closely monitored during treatment with digoxin.
Clinical Trials Related to Digibind (Digoxin Immune Fab)
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease [Recruiting]
The purpose of this study is to examine the effects of the digibind drug on hemodialysis
patients with high blood pressure. Digibind is used to treat toxicity from digoxin and
digoxin-like molecules which may contribute to high blood pressure.
Efficacy Study of Digibind for Treatment of Severe Preeclampsia [Completed]
The purpose of this study is to determine whether a commercially available anti-digoxin
antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this
would allow more time for maternally administered steroids to prevent the development of
respiratory complications in premature infants.
Antibodies to Digoxin for Bipolar Disorder [Recruiting]
Subjects suffering from bipolar disorders treated with specific medications will give their
informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab).
Their response to this therapy will be measured accordingly. Previous medications will be not
changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured
using a specific laboratory technique and these compounds will be measured at 6 and 24 hours
after Fab therapy.
Patients also will be followed using clinical and psychological tests
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Page last updated: 2011-12-09
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