|
gptkbp:instance_of
|
gptkb:monoclonal_antibody
|
|
gptkbp:access
|
patient assistance programs
|
|
gptkbp:administration_training
|
required for patients
|
|
gptkbp:biologic_license
|
BLA 761042
|
|
gptkbp:class
|
gptkb:nuclear_weapons
|
|
gptkbp:clinical_trial
|
Phase III
HAVEN 1
HAVEN 2
HAVEN 3
HAVEN 4
|
|
gptkbp:clinical_use
|
preventing bleeding in patients with hemophilia A
|
|
gptkbp:contraindication
|
known hypersensitivity to emicizumab
|
|
gptkbp:dosage_form
|
injection
|
|
gptkbp:dosing_adjustment
|
based on body weight
|
|
gptkbp:drug_interactions
|
none significant
|
|
gptkbp:effective_date
|
2017-11-16
|
|
gptkbp:financial_support
|
available
|
|
gptkbp:formulation
|
lyophilized powder
|
|
gptkbp:history
|
developed by Genentech
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Hemlibra
|
|
gptkbp:indication
|
prophylaxis of bleeding episodes
|
|
gptkbp:ingredients
|
gptkb:emicizumab
|
|
gptkbp:invention
|
patented
|
|
gptkbp:is_effective_against
|
effective in reducing bleeds
|
|
gptkbp:is_monitored_by
|
recommended during treatment
|
|
gptkbp:manufacturer
|
gptkb:Genentech
|
|
gptkbp:market_position
|
global
|
|
gptkbp:marketed_as
|
gptkb:Hemlibra
|
|
gptkbp:mechanism_of_action
|
mimics factor VIII
|
|
gptkbp:patient_education
|
injection technique
|
|
gptkbp:patient_population
|
adults and children
|
|
gptkbp:pharmacokinetics
|
long half-life
factor VIII replacement therapy
|
|
gptkbp:pharmacovigilance
|
ongoing
|
|
gptkbp:price
|
high
|
|
gptkbp:provides_guidance_on
|
recommended for prophylaxis
|
|
gptkbp:recommissioned
|
with sterile water
|
|
gptkbp:regulatory_compliance
|
FDA approved
|
|
gptkbp:research_areas
|
hemophilia treatment
|
|
gptkbp:route_of_administration
|
subcutaneous
|
|
gptkbp:safety_features
|
generally well tolerated
|
|
gptkbp:safety_measures
|
post-marketing surveillance
|
|
gptkbp:service_frequency
|
once weekly or once every two weeks
|
|
gptkbp:shelf_life
|
36 months
|
|
gptkbp:side_effect
|
fatigue
headache
nausea
injection site reactions
serious allergic reactions
thrombotic microangiopathy
|
|
gptkbp:storage
|
refrigerated
|
|
gptkbp:structure
|
gptkb:Ig_G4
|
|
gptkbp:targets
|
activated factor X
|
|
gptkbp:trade
|
gptkb:Hemlibra
|
|
gptkbp:treatment
|
reduced bleeding episodes
|
|
gptkbp:used_for
|
gptkb:hemophilia_A
|
|
gptkbp:website
|
subcutaneous tissue
|
|
gptkbp:bfsParent
|
gptkb:Emicizumab
gptkb:Shire_plc
|
|
gptkbp:bfsLayer
|
5
|