516:
chronic digoxin poisoning. Data also support outcomes of acute digoxin poisoning without use of anti‐digoxin Fab. A case series of 147 patients showed that not all cases of acute digoxin overdose require anti‐digoxin Fab, nor should anti‐digoxin Fab dose be calculated based on ingested dose. In contrast, a higher mortality (7.6%) was noted in a case series of acute and chronic digoxin and digitoxin poisoning despite Fab being used first line. Further, a retrospective case‐controlled study of chronic digoxin poisoning did not observe a beneficial effect of anti‐digoxin Fab on mortality. An RCT (n = 66) in yellow oleander poisoning showed an early improvement in cardiac rhythm and hyperkalaemia from anti‐digoxin Fab, prompting early termination of the trial. It was not powered to detect a change in mortality and no deaths were noted. As with all foreign proteins, anaphylaxis, serum sickness or febrile reactions are a source of concern, especially with repeated administration. These reactions appear uncommon for example, in a study of 717 adults where only six patients (0.8%) exhibited any evidence of allergic response. Nevertheless, theoretically, patients previously dependent upon the inotropic effects of digoxin could develop heart failure and hypokalaemia could result within 1–5 hours, owing to intracellular shifts of potassium, as the effects of digoxin are reversed. Patients who require redigitalization must wait for the complexes to be eliminated from the body by the kidneys, this taking 2–3 days with normal renal function. Unfortunately, fab fragments interfere with both fluorescence excitation transfer immunoassays and radioimmunoassays for digoxin. This means that serum drug levels cannot be monitored until the drug-antibody complexes are cleared from the circulation.
594:. DigiFab is manufactured and distributed by BTG international Inc. under U.S. License No. 186. DigiFab is a sterile, lyophilized preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments. It 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. 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 and is intended for intravenous administration.
615:
530:
676:
per 38 mg vial and US $ 786 per 40 mg vial respectively. After GSK discontinued
Digibind sale in USA in 2011, the AWP of DigiFab increases by 15% to US $ 903 per 40 mg vial. AWP of DigiFab has continued to increase as much as 54% occurring in March 2014 to US $ 2,370 per 40 mg vial. However, the cost may vary depending on wholesaler contractor manufacturer rebates.
29:
675:
Price increase was reported to range from US $ 380 to US $ 750 during 2013 for digoxin-Fab. However, these price increases are not reflective of the United States average AWP for digoxin-Fab as it represents
Australian costs converted to US. Prior to 2011, Digibind and DigiFab pricing was US $ 797
515:
Case series have reported benefits from anti‐digoxin Fab, but data regarding the response in acute or chronic poisoning are conflicting. Recent observational data support an effect in acute poisoning, but efficacy in chronic poisoning be minimally effective in alleviating cardiac toxicities in
600:
A patent to use digoxin immunoglobulins C07k16/44 as a regulator of the preeclamptic/eclamptic patient's sodium/potassium ATPase activity was approved in 2003 to
Charles David Adair under application number WO2004011028A1.
403:. Digoxin toxicity can emerge during long-term therapy as well as after an overdose. It can occur even when the serum digoxin concentration is within the therapeutic range when one of the following is present:
135:
90:
343:
507:
It works by binding to the digoxin, rendering it unable to bind to its action sites on target cells. The complexes accumulate in the blood and are expelled by the kidney.
54:
693:
499:
into Fab and Fc fragments) should not use ovine digoxin immune fab. Because it is relatively new, no drug interaction studies have been performed yet.
597:
Digibind is manufactured by GlaxoSmithkline, SpA, Parma Italy under US License No. 129. It’s distributed by GSK, Research
Triangle park, NC 27709.
1602:
969:
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1203:
625:
540:
384:
644:
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544:
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1103:
828:"Digibind, DigiFab (digoxin immune FAB (Antidote)) dosing, indications, interactions, adverse effects, and more"
1607:
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1050:
962:
72:
1581:
1547:
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1437:
1349:
749:"Analysis of the use of digoxin immune fab for the treatment of non-life-threatening digoxin toxicity"
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64:
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20:
694:"Prescription medicines: registration of new chemical entities in Australia, 2014"
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919:
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774:
592:
as an antidote to treat a life-threatening overdose of digoxin or digitoxin
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28:
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potassium levels and could precipitate dangerous and even fatal
951:
853:
Roberts DM, Gallapatthy G, Dunuwille A, Chan BS (March 2016).
747:
DiDomenico RJ, Walton SM, Sanoski CA, Bauman JL (April 2000).
608:
523:
129:
855:"Pharmacological treatment of cardiac glycoside poisoning"
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digoxin level > 4 ng/ml if chronic ingestion
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digoxin level > 10 ng/ml if acute ingestion
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426:Side effects of digoxin immune fab may occur:
963:
904:"Diagnosis and treatment of digoxin toxicity"
464:as this drug, while reversing the effects of
436:swelling of the lips, tongue, face, or throat
8:
19:
643:. Unsourced material may be challenged and
558:. Unsourced material may be challenged and
511:Regulatory information and clinical studies
172:15 hours for DigiFab, 23 hours for Digibind
1314:
1232:
998:
970:
956:
948:
802:LITFL • Life in the Fast Lane Medical Blog
717:
715:
479:The patient must be closely monitored for
387:(DDMA). Its brand names include Digibind (
27:
927:
902:Lip GY, Metcalfe MJ, Dunn FG (May 1993).
878:
764:
663:Learn how and when to remove this message
578:Learn how and when to remove this message
859:British Journal of Clinical Pharmacology
483:, and anyone allergic to sheep protein,
379:that have already been immunized with a
685:
495:extracts (papain is used to cleave the
232:
212:
698:Therapeutic Goods Administration (TGA)
422:potassium > 5 mEq/L and symptomatic
18:
268:
63:
7:
641:adding citations to reliable sources
556:adding citations to reliable sources
102:
14:
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528:
302:
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367:is an antidote for overdose of
314:
308:
290:
215:Anti-digoxin antibody fragment
1:
385:digoxindicarboxymethoxylamine
908:Postgraduate Medical Journal
723:"digoxin immune Fab (ovine)"
33:Bottle of digoxin immune fab
1663:
796:Nickson C (11 July 2014).
280:Chemical and physical data
1597:
1555:Prednisolone/promethazine
1536:Methylthioninium chloride
407:Hemodynamically unstable
391:) and DigiFab (BTG plc).
365:digoxin-specific antibody
340:
203:
65:Consumer Drug Information
26:
920:10.1136/pgmj.69.811.337
1548:Potassium permanganate
1204:neuromuscular blockade
468:, will further reduce
1350:4-Dimethylaminophenol
520:Intellectual property
1438:Paracetamol toxicity
1282:direct Xa inhibitors
1003:Alcohol intoxication
766:10.1053/XV.2000.5590
637:improve this section
552:improve this section
808:on 20 February 2016
474:cardiac arrhythmias
433:difficult breathing
138:(Prescription only)
23:
16:Pharmaceutical drug
1624:Never to phase III
1421:Primary alcohols:
1379:Sodium thiosulfate
1263:Digoxin immune fab
798:"Digoxin Toxicity"
605:Commercial aspects
481:anaphylactic shock
371:. It is made from
361:Digoxin immune fab
178:Duration of action
21:Digoxin immune fab
1634:
1633:
1563:
1562:
1397:Calcium gluconate
1389:Hydrofluoric acid
1342:Cyanide poisoning
1319:Arsenic poisoning
1306:
1305:
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1219:
871:10.1111/bcp.12814
673:
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588:
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456:Contraindications
358:
357:
133:
1654:
1529:Potassium iodide
1355:Hydroxocobalamin
1315:
1255:Digoxin toxicity
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949:
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931:
914:(811): 337–339.
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804:. Archived from
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401:digoxin toxicity
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49:Digibind, others
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1587:Syrup of ipecac
1559:
1542:oxidizing agent
1510:
1462:
1441:(Acetaminophen)
1440:
1432:
1413:
1412:Ethylene glycol
1410:
1401:
1383:
1336:
1302:
1267:
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1227:
1216:
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1159:Opioid overdose
1153:
1105:
1104:Organophosphate
1102:
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451:lightheadedness
399:It is used for
397:
389:GlaxoSmithKline
375:fragments from
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344:(what is this?)
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1577:Copper sulfate
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1448:Acetylcysteine
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1286:Andexanet alfa
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865:(3): 488–495.
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700:. 21 June 2022
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1508:
1507:Prussian blue
1505:
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1199:
1193:
1190:
1188:
1185:
1183:
1180:
1178:
1175:
1173:
1170:
1168:
1167:Diprenorphine
1165:
1164:
1162:
1160:
1156:
1150:
1147:
1144:
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1137:
1135:
1132:
1131:
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1127:
1125:
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1120:
1117:
1115:
1112:
1111:
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1107:
1100:
1096:
1090:
1087:
1085:
1084:Physostigmine
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1079:
1077:
1073:
1067:
1064:
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728:
727:www.glowm.com
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622:This section
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537:This section
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463:
460:Avoid use in
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39:Clinical data
37:
30:
25:
1540:
1521:
1468:Toxic metals
1367:Amyl nitrite
1359:
1262:
1237:Beta blocker
1145:
1076:GHB overdose
911:
907:
897:
862:
858:
848:
836:. Retrieved
831:
822:
810:. Retrieved
806:the original
801:
791:
759:(2): 77–85.
756:
752:
742:
730:. Retrieved
726:
702:. Retrieved
697:
688:
674:
659:
653:January 2018
650:
635:Please help
623:
599:
596:
591:
589:
574:
568:January 2018
565:
550:Please help
538:
514:
506:
503:Pharmacology
478:
459:
442:skin redness
425:
398:
395:Medical uses
383:derivative,
364:
360:
359:
348:
342:
182:15 to 20 hrs
165:Elimination
121:Legal status
115:Legal status
1610:from market
1582:Ipecacuanha
1497:Dimercaprol
1453:Glutathione
1327:Dimercaprol
1226:Circulatory
1201:Reversal of
1139:Pralidoxime
1099:Nerve agent
1061:Cyprodenate
1026:Barbiturate
834:. WebMD LLC
732:8 September
462:hypokalemia
336: g·mol
199:Identifiers
80:IV infusion
45:Trade names
1647:Antitoxins
1523:iodine-131
1458:Methionine
1428:Fomepizole
1212:Sugammadex
1192:Naltrexone
1182:Nalorphine
1066:Flumazenil
1011:Metadoxine
680:References
409:arrhythmia
325:Molar mass
245:ChemSpider
208:IUPAC name
1620:Phase III
1608:Withdrawn
1414:poisoning
1297:Protamine
1177:Nalmefene
1146:see also:
1134:Obidoxime
1119:Biperiden
1106:poisoning
1089:SCH-50911
1041:Ethamivan
1036:Bemegride
979:Antidotes
624:does not
539:does not
489:bromelain
466:digitalis
188:Excretion
167:half-life
84:injection
73:Routes of
59:Drugs.com
1641:Category
1502:Edetates
1487:thallium
1407:Methanol
1332:Succimer
1291:against
1280:against
1245:Glucagon
1187:Naloxone
1172:Doxapram
1124:Diazepam
1114:Atropine
1053:overdose
1028:overdose
1016:Thiamine
889:26505271
832:Medscape
783:33064518
775:11150387
704:10 April
497:antibody
445:wheezing
351:(verify)
225:DrugBank
91:ATC code
1482:mercury
1472:cadmium
1423:Ethanol
1361:nitrite
1293:heparin
992:Nervous
938:8346128
929:2399830
880:4767196
838:24 July
812:24 July
645:removed
630:sources
560:removed
545:sources
439:itching
381:digoxin
369:digoxin
286:Formula
234:DB00076
107:)
101: (
99:V03AB24
1603:WHO-EM
1569:Emetic
1228:system
1129:Oximes
994:system
936:
926:
887:
877:
781:
773:
493:papaya
485:papain
261:ChEMBL
193:Kidney
159:30 min
134:
1515:Other
1311:Other
983:V03AB
779:S2CID
491:, or
470:serum
448:cough
430:hives
377:sheep
1477:lead
934:PMID
885:PMID
840:2017
814:2017
771:PMID
734:2020
706:2023
628:any
626:cite
543:any
541:cite
300:3223
294:2085
252:none
149:data
55:AHFS
924:PMC
916:doi
875:PMC
867:doi
761:doi
639:by
554:by
363:or
334:.88
332:301
312:672
306:553
104:WHO
1643::
1616::
932:.
922:.
912:69
910:.
906:.
883:.
873:.
863:81
861:.
857:.
830:.
800:.
777:.
769:.
755:.
751:.
725:.
714:^
696:.
487:,
476:.
330:47
318:16
136:S4
130:AU
82:,
1489:)
1470:(
1409:/
1299:)
1295:(
1288:)
1284:(
1101:/
985:)
981:(
971:e
964:t
957:v
940:.
918::
891:.
869::
842:.
816:.
785:.
763::
757:5
736:.
708:.
666:)
660:(
655:)
651:(
647:.
633:.
581:)
575:(
570:)
566:(
562:.
548:.
315:S
309:O
303:N
297:H
291:C
132::
57:/
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