| 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 (℃) | 62 (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 | N.A. |
| Target | N.A. |
| Information of corresponding available drug in the market |
|---|
| Brand Name | DigiFab |
| Company | Â Protherics Inc |
| Brand Discription | These fragments are obtained from the blood of healthy sheep immunized with a digoxin derivative, digoxin-dicarboxymethoxylamine (DDMA), a digoxin analogue which contains the functionally essential cyclopentaperhydrophenanthrene:lactone ring moiety coupled to keyhole limpet hemocyanin (KLH).The final product is prepared by isolating the immunoglobulin fraction of the ovine serum, digesting it with papain and isolating the digoxin-specific Fab fragments by affinity chromatography. These antibody fragments have a molecular weight of approximately 46,000 Da |
| Prescribed for | DigiFab 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 Name | N.A. |
| Formulation | Each 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 |
| Physcial Appearnce | DigiFab [Digoxin Immune Fab (Ovine)] is a sterile, purified, lyophilized powdered preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments. |
| Route of Administration | Intravenous administration |
| Recommended Dosage | For 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. |
| Contraindication | There are no known contraindications to the use of DigiFab |
| Side Effects | Exacerbation 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 | http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6832767f-db6b-4eea-b88b-bdfc905749e1 |
| PubMed ID | 12194938, 17516918, 17139285 |
| 3-D Structure | Th1065 (View) or (Download) |