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for use in previously treated people twelve years of age and older with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; or routine prophylaxis to reduce the frequency of bleeding episodes.
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In the
European Union, damoctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in previously treated people twelve years of age and older with hemophilia A (congenital factor VIII deficiency).
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Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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Damoctocog alfa pegol was approved for medical use in the United States in August 2018, and in the
European Union in November 2018.
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for "Trial to
Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration" at
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for "A Trial
Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A (PROTECT-VIII)" at
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for "Safety and
Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A" at
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476:"Jivi damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe (384590)"
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The most common side effects include headache, cough, nausea, and fever.
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This article incorporates text from this source, which is in the
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BAY94-9027, antihemophilic factor (recombinant), pegylated-aucl
548:"Jivi (antihemophilic factor- recombinant pegylated-aucl kit"
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https://www.tga.gov.au/resources/auspar/auspar-jivi
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667:"Damoctocog Alfa Pegol: A Review in Haemophilia A"
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416:In the United States damoctocog alfa pegol is
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228:In general: ℞ (Prescription only)
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1089:Tetragalacturonic acid hydroxymethylester
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517:"Regulatory Decision Summary for Jivi"
480:Therapeutic Goods Administration (TGA)
450:Therapeutic Goods Administration (TGA)
20:
61:
7:
636:from the original on 30 October 2020
558:from the original on 11 October 2020
152:
598:from the original on 2 October 2020
309:
632:. 29 August 2018. STN: BL 125661.
14:
964:(II, VII, IX, X, protein C and S)
486:from the original on 8 April 2023
456:from the original on 8 April 2023
1199:
646:
523:from the original on 7 June 2022
343:
337:
1007:thrombopoietin receptor agonist
962:Prothrombin complex concentrate
1099:Hemostatic Powder Spray TC-325
665:Paik J, Deeks ED (July 2019).
355:
349:
331:
1:
628:Food and Drug Administration
386:, sold under the brand name
1243:
894:Valoctocogene roxaparvovec
683:10.1007/s40265-019-01152-7
398:concentrate used to treat
321:Chemical and physical data
1055:Absorbable gelatin sponge
590:European Medicines Agency
904:Fidanacogene elaparvovec
1138:Aminomethylbenzoic acid
392:recombinant DNA-derived
741:Clinical trial number
729:Clinical trial number
717:Clinical trial number
870:Damoctocog alfa pegol
594:. 24 September 2018.
384:Damoctocog alfa pegol
23:Damoctocog alfa pegol
1227:Recombinant proteins
519:. 23 October 2014.
188:(Prescription only)
25:
1084:Oxidized cellulose
874:Efanesoctocog alfa
749:ClinicalTrials.gov
737:ClinicalTrials.gov
725:ClinicalTrials.gov
554:. 30 August 2018.
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1186:
1157:Alfa1 antitrypsin
1128:Aminocaproic acid
1113:Antifibrinolytics
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1043:
1042:
878:Efmoroctocog alfa
828:Phytomenadione (K
677:(10): 1147–1156.
482:. 28 March 2023.
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1222:Antihemorrhagics
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1162:C1-inhibitor
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1018:Avatrombopag
1005:
1001:Fostamatinib
958:
952:Catridecacog
943:I/Fibrinogen
929:
923:Eptacog alfa
915:
908:Nonacog alfa
869:
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837:Menadione (K
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638:. Retrieved
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600:. Retrieved
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458:. Retrieved
449:
423:
415:
412:Medical uses
407:
404:
400:hemophilia A
387:
383:
382:
251:1363853-26-2
171:Legal status
165:Legal status
71:License data
18:
1177:Ulinastatin
1122:amino acids
1079:Fibrin glue
1070:Epinephrine
1023:Eltrombopag
1013:Romiplostim
938:II/Thrombin
851:Coagulation
803:coagulation
744:NCT01775618
732:NCT01580293
720:NCT01184820
585:"Jivi EPAR"
396:Factor VIII
377: g·mol
236:Identifiers
134:Intravenous
44:Other names
35:Trade names
1216:Categories
1074:adrenalone
996:Etamsylate
991:Concizumab
981:Batroxobin
916:extrinsic:
861:intrinsic:
429:References
366:Molar mass
291:BY4TSK952Y
242:CAS Number
204:Schedule D
1173:unsorted
1152:Aprotinin
820:Vitamin K
640:1 October
602:1 October
562:1 October
418:indicated
127:Routes of
101:Pregnancy
63:Monograph
57:Drugs.com
1206:Medicine
1167:Camostat
1094:Thrombin
1065:Collagen
974:systemic
812:Systemic
701:31218660
634:Archived
596:Archived
556:Archived
552:DailyMed
521:Archived
484:Archived
454:Archived
262:DrugBank
141:ATC code
116: B2
103:category
85:DailyMed
1146:serpins
930:common:
853:factors
692:6711950
490:7 April
460:7 April
327:Formula
271:DB14700
200: /
196::
157:)
151: (
149:B02BD02
87::
1192:Portal
699:
689:
622:"Jivi"
527:7 June
446:"Jivi"
311:D10759
215:℞-only
213:
202:
198:℞-only
184:
83:
1048:Local
972:Other
671:Drugs
630:(FDA)
626:U.S.
592:(EMA)
390:is a
341:11318
948:XIII
866:VIII
697:PMID
642:2020
604:2020
564:2020
529:2022
492:2023
462:2023
388:Jivi
353:2184
347:1984
335:7445
302:KEGG
282:UNII
53:AHFS
39:Jivi
919:VII
789:B02
687:PMC
679:doi
375:.28
373:774
371:165
154:WHO
1218::
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902:/(
900:IX
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448:.
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402:.
394:,
359:69
221:EU
209:US
193:CA
186:S4
180:AU
112:AU
80:US
1194::
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356:S
350:O
344:N
338:H
332:C
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55:/
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.