|
gptkbp:instanceOf
|
gptkb:drug
|
|
gptkbp:administeredBy
|
adults
children
|
|
gptkbp:approvalYear
|
2017
|
|
gptkbp:approvedBy
|
gptkb:FDA
gptkb:EMA
|
|
gptkbp:ATCCode
|
gptkb:B02BX06
|
|
gptkbp:blackBoxWarning
|
thrombotic microangiopathy and thromboembolism with aPCC use
|
|
gptkbp:CASNumber
|
gptkb:1623229-27-6
|
|
gptkbp:chemicalFormula
|
C6488H9996N1724O2026S44
|
|
gptkbp:clinicalTrialPhase
|
gptkb:HAVEN_1
gptkb:HAVEN_2
gptkb:HAVEN_3
gptkb:HAVEN_4
|
|
gptkbp:drugClass
|
gptkb:monoclonal_antibody
|
|
gptkbp:firstBook
|
yes
|
|
gptkbp:form
|
solution for injection
|
|
gptkbp:genericName
|
gptkb:emicizumab
|
|
gptkbp:halfLife
|
~4 weeks
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Hemlibra
|
|
gptkbp:indication
|
patients with or without factor VIII inhibitors
prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients
|
|
gptkbp:legalStatus
|
prescription only
|
|
gptkbp:manufacturer
|
gptkb:Genentech
gptkb:Roche
|
|
gptkbp:marketedIn
|
gptkb:Australia
gptkb:Canada
gptkb:European_Union
gptkb:Japan
gptkb:United_States
|
|
gptkbp:mechanismOfAction
|
bispecific monoclonal antibody
bridges activated factor IX and factor X
|
|
gptkbp:patent
|
gptkb:Chugai_Pharmaceutical
|
|
gptkbp:pregnancyCategory
|
not assigned (consult physician)
|
|
gptkbp:prescriptionRequired
|
https://www.gene.com/download/pdf/hemlibra_prescribing.pdf
|
|
gptkbp:routeOfAdministration
|
subcutaneous injection
|
|
gptkbp:sideEffect
|
gptkb:thrombotic_microangiopathy
fever
headache
injection site reaction
arthralgia
thromboembolism
|
|
gptkbp:storage
|
2°C to 8°C
|
|
gptkbp:target
|
gptkb:factor_IXa
gptkb:factor_X
|
|
gptkbp:UNII
|
Q2I0K6F1G2
|
|
gptkbp:usedFor
|
gptkb:hemophilia_A
|
|
gptkbp:bfsParent
|
gptkb:Roche
gptkb:Chugai_Pharmaceutical
|
|
gptkbp:bfsLayer
|
6
|