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10404 details
Primary information
ID10404
Therapeutic IDTh1065
Protein NameDigoxin Immune Fab (Ovine)
Sequence>Th1065_Digoxin_Immune_Fab_(Ovine) EVQLQQSGPELVKPGASVRMSCKSSGYIFTDFYMNWVRQSHGKSLDYIGYISPYSGVTGYNQKFKGKATLTVDKSSSTAYMELRSLTSEDSAVYYCAGSSGNKWAMDYWGHGASVTVSSAKTTAPSVYPLAPVCGDTTGSSVTLGCLVKGYFPEPVTLTWNSGSLSSGVHTFPAVLQSDLYTLSSSVTVTSSTWPSQSITCNVAHPASSTKVDKKIEP
Molecular Weight47301.7
Chemical FormulaC2085H3223N553O672S16
Isoelectric Point8.01
Hydrophobicity-0.343
Melting point61 (FAB f
Half-life15-20 hrs
DescriptionDigoxin Immune Fab is a sheep antibody (26-10) FAB fragment from sheep immunized with the digoxin derivative Digoxindicarboxymethylamine. It is used as an antidote for overdose of digoxin.
Indication/DiseaseFor treatment of digitoxin overdose or digitalis glycoside toxicity.
PharmacodynamicsDigiFab binds molecules of digoxin, making them unavailable for binding at their site of action on cells in the body. The Fab fragment-digoxin complex accumulates in the blood, from which it is excreted by the kidney. The net effect is to shift the equilibrium away from binding of digoxin to its receptors in the body, thereby reversing its effects.
Mechanism of ActionBinds excess digoxin or digitoxin molecules circulating in the blood.
ToxicityNA
MetabolismNA
AbsorptionNA
0.3 L/kg [DigiFab] 0.4 L/kg [Digibind]
ClearanceNA
CategoriesAmino Acids, Peptides, and Proteins, Antidotes, Blood Proteins, Digoxin Binding Activity, Immunoglobulin G, Immunoglobulins, Proteins, Serum, Serum Globulins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
Brand NameDigiFab
Company Protherics Inc, Btg International Inc, Savage Laboratories a division of Fougera Pharmaceuticals Inc.
Brand Description Protherics Inc, Btg International Inc, Savage Laboratories a division of Fougera Pharmaceuticals Inc.
Prescribed ForDigiFab is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. Although designed specifically to treat digoxin overdose, a product very similar to DigiFab (Digibind) has been used successfully to treat life-threatening digitoxin overdose.
Chemical NameNA
FormulationEach vial of DigiFab, which will bind approximately 0.5 mg digoxin, contains 40 mg of digoxin immune Fab, 75 mg (approx) of mannitol USP, and 2 mg (approx) sodium acetate USP as a buffering agent. The product contains no preservatives after reconstitution with 4 mL of Sterile Water for Injection USP
Physical Appearance DigiFab [Digoxin Immune Fab (Ovine)] is a sterile, purified, lyophilized powdered preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments.ÂÂ
Route of AdministrationIntravenous administrationÂÂ
Recommended DosageFor adult patients who are in acute distress or for whom a serum digoxin concentration is not available, 6 vials (240 mg) should be adequate to reverse most cases of toxicity.
ContraindicationThere are no known contraindications to the use of DigiFab
Side EffectsExacerbation of low cardiac output states and congestive heart failure due to the withdrawal of inotropic effect of digitalis. Hypokalemia due to reactivation of the sodium-potassium ATPase. Rapid ventricular response in patients with atrial fibrillation due to withdrawal of the effects of digitalis on the atrioventricular node. Rare allergic reactions Patients with a history of allergy, especially to antibiotics, appear to be at particular risk.
Useful Link 1Link
Useful Link 2NA
RemarksNA