|
gptkbp:instance_of
|
gptkb:pharmaceuticals
|
|
gptkbp:approves
|
gptkb:FDA
|
|
gptkbp:availability
|
limited to certain countries
|
|
gptkbp:clinical_trial
|
Phase 3
NCT03220462
NCT03220476
NCT03220489
|
|
gptkbp:contraindication
|
none known
|
|
gptkbp:dosage_form
|
gptkb:Software_Solutions
|
|
gptkbp:drug_interactions
|
none significant
|
|
gptkbp:duration
|
up to 24 weeks
|
|
gptkbp:effective_date
|
January 2020
|
|
gptkbp:eligibility
|
based on diagnosis
|
|
gptkbp:events
|
12 months
|
|
gptkbp:financial_support
|
available
|
|
gptkbp:formulation
|
lyophilized powder
|
|
gptkbp:frequency
|
every 3 weeks
|
|
gptkbp:funding
|
provided by Horizon Therapeutics
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Tepezza
|
|
gptkbp:indication
|
active thyroid eye disease
|
|
gptkbp:ingredients
|
teprotumumab
|
|
gptkbp:initial_dose
|
14 mg/kg
|
|
gptkbp:invention
|
2028
|
|
gptkbp:is_effective_against
|
improved quality of life
improved proptosis
|
|
gptkbp:maintenance_dose
|
10 mg/kg
|
|
gptkbp:manufacturer
|
gptkb:Horizon_Therapeutics
|
|
gptkbp:market_authorization
|
granted by FDA
|
|
gptkbp:marketed_as
|
gptkb:United_States
|
|
gptkbp:mechanism_of_action
|
IGF-1 receptor antagonist
|
|
gptkbp:patient_population
|
adults
|
|
gptkbp:pharmacokinetics
|
gptkb:monoclonal_antibody
inhibits IGF-1 receptor signaling
|
|
gptkbp:price
|
approximately $14,000 per dose
|
|
gptkbp:provides_guidance_on
|
recommended for treatment
|
|
gptkbp:requires
|
gptkb:true
available online
|
|
gptkbp:research
|
ongoing
|
|
gptkbp:route_of_administration
|
intravenous
|
|
gptkbp:safety_features
|
generally well tolerated
|
|
gptkbp:safety_measures
|
recommended during treatment
|
|
gptkbp:side_effect
|
fatigue
headache
nausea
diarrhea
dry skin
infusion-related reactions
alopecia
hearing impairment
hyperglycemia
muscle spasms
|
|
gptkbp:storage
|
refrigerated
|
|
gptkbp:trade
|
teprotumumab-trbw
|
|
gptkbp:treatment
|
improvement in vision
reduction in eye bulging
|
|
gptkbp:type_of_care
|
important for efficacy
|
|
gptkbp:used_for
|
thyroid eye disease
|
|
gptkbp:bfsParent
|
gptkb:Horizon_Therapeutics
|
|
gptkbp:bfsLayer
|
5
|