| Primary information |
|---|
| ThPP ID | Th1065 |
| Therapeutic Peptide/Protein Name | Digoxin Immune Fab (Ovine) |
| Sequence | Heavy Chain: EVQLQQSGPELVKPGASVRMSCKSSGYIFTDFYMNWV view full sequnce in fasta |
| Functional Classification | IIa |
| Molecular Weight | 47301.7 |
| Chemical Formula | C2085H3223N553O672S16 |
| Isoelectric Point | 8.01 |
| Hydrophobicity | -0.343 |
| Melting Point (℃) | 61 (FAB f |
| Half Life | 15-20 hrs |
| Description | Digoxin 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/Disease | For treatment of digitoxin overdose or digitalis glycoside toxicity. |
| Pharmacodynamics | DigiFab 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 Action | Binds excess digoxin or digitoxin molecules circulating in the blood. |
| Toxicity | N.A. |
| Metabolism | N.A. |
| Absorption | N.A. |
| Volume of Distribution | 0.3 L/kg [DigiFab] 0.4 L/kg [Digibind] |
| Clearance | N.A. |
| Categories | Antidotes |
| Patents Number | N.A. |
| Date of Issue | N.A. |
| Date of Expiry | N.A. |
| Drug Interaction | Cinitapride can alter the absorption of digoxin as it simulates gastric emptying |
| Target | N.A. |
| Information of corresponding available drug in the market |
|---|
| Brand Name | DIGIBIND |
| Company | Galaxo Smith Kline |
| Brand Discription | 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. These antibody fragments have a molecular weight of approximately 46,200. |
| Prescribed for | DIGIBIND, Digoxin Immune Fab (Ovine), is indicated for treatment of potentially life-threatening digoxin intoxication. Although designed specifically to treat life-threatening digoxin overdose, it has also been used successfully to treat life-threatening digitoxin overdose. Since human experience is limited and the consequences of repeated exposures are unknown, DIGIBIND is not indicated for milder cases of digitalis toxicity. |
| Chemical Name | N.A. |
| Formulation | Each vial, which will bind approximately 0.5 mg of digoxin (or digitoxin), contains 38 mg of digoxin-specific Fab fragments derived from sheep plus 75 mg of sorbitol as a stabilizer and 28 mg of sodium chloride. The vial contains no preservatives. |
| Physcial Appearnce | DIGIBIND, Digoxin Immune Fab (Ovine), is a Sterile lyophilized powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep. |
| Route of Administration | Intravenous infusion after reconstitution with Ste |
| Recommended Dosage | Each vial of DIGIBIND (digoxin immune fab) contains 38 mg of purified digoxin-specific Fab fragments which will bind approximately 0.5 mg of digoxin (or digitoxin). Dose (in # of vials) = Total digitalis body load in mg / 0.5 mg of digitalis bound/vial |
| Contraindication | There are no known contraindications to the use of DIGIBIND. |
| Side Effects | Allergic reactions to DIGIBIND (digoxin immune fab) have been reported rarely. Patients with a history of allergy, especially to antibiotics, appear to be at particular risk. In a few instances, low cardiac output states and congestive heart failure could have been exacerbated by withdrawal of the inotropic effects of digitalis. Hypokalemia may occur from re-activation of (sodium, potassium) ATPase. Patients with atrial fibrillation may develop a rapid ventricular response from withdrawal of the effects of digitalis on the atrioventricular node. |
| Useful Link | Wenger TL, Butler VP Jr, Haber E, Smith TW. Treatment of 63 severely digitalis-toxic patients with digoxin-specific antibody fragments. J Am Coll Cardiol. 1985; 5:118A-123A http://www.rxlist.com/digibind-drug.htm http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=12121 |
| PubMed ID | 12194938, 17516918, 17139284 |
| 3-D Structure | Th1065 (View) or (Download) |