|
gptkbp:instanceOf
|
pharmaceutical drug
|
|
gptkbp:activeDuring
|
gptkb:parathyroid_hormone
|
|
gptkbp:administrativeDivision
|
once daily
|
|
gptkbp:clinicalTrials
|
gptkb:Canada
gptkb:United_States
Europe
ongoing
Phase 3
improved quality of life
subcutaneous injection
positive efficacy
recommended for treatment of hypoparathyroidism
reduced hypocalcemia episodes
|
|
gptkbp:community_service
|
available
|
|
gptkbp:contraindication
|
hypercalcemia
hypersensitivity to the drug
neoplastic disease
|
|
gptkbp:date
|
FDA_approved
|
|
gptkbp:developedBy
|
gptkb:OPKO_Health
|
|
gptkbp:dosageForm
|
solution
|
|
gptkbp:drugInterdiction
|
none reported
|
|
gptkbp:firstAppearance
|
2019-10-30
|
|
gptkbp:formulation
|
injectable
|
|
gptkbp:hasCompetitors
|
limited
|
|
gptkbp:hasPopulation
|
children
adults
|
|
gptkbp:healthcare
|
important for efficacy
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
OPKO 4100
|
|
gptkbp:insuranceAccepted
|
varies by plan
|
|
gptkbp:mandates
|
hypoparathyroidism treatment
|
|
gptkbp:manufacturer
|
gptkb:OPKO_Health,_Inc.
|
|
gptkbp:marketedAs
|
gptkb:Canada
gptkb:European_Union
gptkb:United_States
brand name
|
|
gptkbp:offers
|
high
|
|
gptkbp:patentStatus
|
patented
|
|
gptkbp:regulatoryBody
|
gptkb:FDA
gptkb:Health_Canada
EMA
|
|
gptkbp:research
|
gptkb:OPKO_Health
|
|
gptkbp:researchFocus
|
calcium homeostasis
hypoparathyroidism
bone metabolism
|
|
gptkbp:route
|
subcutaneous
|
|
gptkbp:shelfLife
|
24 months
|
|
gptkbp:sideEffect
|
fatigue
headache
nausea
injection site reactions
|
|
gptkbp:storage
|
refrigerated
|
|
gptkbp:triggerType
|
replaces parathyroid hormone
|
|
gptkbp:usedFor
|
treatment of hypoparathyroidism
|