Prolia

GPTKB entity

Statements (53)
Predicate Object
gptkbp:instanceOf gptkb:drug
gptkbp:activeIngredient gptkb:denosumab
gptkbp:approvalYear 2010
gptkbp:approvedBy gptkb:FDA
gptkb:EMA
gptkbp:associatedWith gptkb:Xgeva
gptkbp:ATCCode gptkb:M05BX04
gptkbp:brand gptkb:Prolia
gptkbp:chemicalFormula gptkb:C6400H9908N1720O2016S44
gptkbp:contraindication hypocalcemia
gptkbp:drugClass gptkb:monoclonal_antibody
gptkbp:form solution for injection
gptkbp:frequency every 6 months
gptkbp:genericName gptkb:denosumab
gptkbp:halfLife 25 days
https://www.w3.org/2000/01/rdf-schema#label Prolia
gptkbp:immunogenicity low
gptkbp:indication bone loss due to hormone ablation in cancer
men at increased risk of fractures
postmenopausal women with osteoporosis
gptkbp:legalStatus prescription only
gptkbp:manufacturer gptkb:Amgen
gptkbp:marketedIn gptkb:Australia
gptkb:Canada
gptkb:European_Union
gptkb:United_States
gptkbp:mechanismOfAction RANKL inhibitor
gptkbp:molecularWeight 147 kDa
gptkbp:monitoredParameter renal function
serum calcium
signs of infection
gptkbp:patent gptkb:Amgen
gptkbp:pharmacokinetics linear
gptkbp:pregnancyCategory Category D
not recommended
Category X
gptkbp:prescriptionRequired https://www.prolia.com/
gptkbp:prescriptionStatus Rx only
gptkbp:reimbursementStatus covered by Medicare Part B (US)
gptkbp:riskFactor skin infections
hypersensitivity reactions
osteonecrosis of the jaw
atypical femoral fracture
gptkbp:routeOfAdministration subcutaneous injection
gptkbp:sideEffect infections
dermatitis
hypocalcemia
osteonecrosis of the jaw
gptkbp:storage 2-8°C
gptkbp:usedFor gptkb:bone
bone loss
gptkbp:bfsParent gptkb:Amgen
gptkbp:bfsLayer 6