Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:administered_by |
subcutaneous injection
|
| gptkbp:administered_every |
6 months
|
| gptkbp:approves |
gptkb:FDA
|
| gptkbp:clinical_trial |
gptkb:ARCH_trial
gptkb:FREEDOM_trial gptkb:REPLACE_trial Phase 3 DATA trial FREEDOM Extension trial |
| gptkbp:clinical_use |
treatment of osteoporosis
treatment of bone loss associated with hormone ablation |
| gptkbp:contraindication |
pregnancy
lactation hypersensitivity to denosumab hypocalcemia |
| gptkbp:dosage_form |
injection
|
| gptkbp:excretion |
via the reticuloendothelial system
|
| gptkbp:formulation |
solution for injection
|
| https://www.w3.org/2000/01/rdf-schema#label |
Prolia
|
| gptkbp:indication |
prevention of bone fractures
|
| gptkbp:ingredients |
gptkb:denosumab
|
| gptkbp:interacts_with |
other medications affecting calcium levels
|
| gptkbp:is_monitored_by |
bone mineral density
calcium levels |
| gptkbp:lifespan |
about 26 days
|
| gptkbp:long_term_use |
safety and efficacy established
|
| gptkbp:manufacturer |
gptkb:Amgen
|
| gptkbp:marketed_as |
gptkb:2010
|
| gptkbp:mechanism_of_action |
RANKL inhibitor
|
| gptkbp:packaging |
single-use prefilled syringe
|
| gptkbp:patient_education |
importance of calcium and vitamin D
importance of regular dental check-ups signs of infection to report |
| gptkbp:patient_population |
postmenopausal women
men at high risk for fracture |
| gptkbp:pharmacokinetics |
subcutaneous absorption
|
| gptkbp:price |
varies by region and insurance
|
| gptkbp:regulatory_compliance |
approved in multiple countries
|
| gptkbp:requires |
available from manufacturer
|
| gptkbp:route_of_administration |
subcutaneous
|
| gptkbp:safety_features |
generally well tolerated
|
| gptkbp:side_effect |
injection site reactions
skin rash osteonecrosis of the jaw hypocalcemia atypical femoral fractures |
| gptkbp:storage |
refrigerated
|
| gptkbp:trade |
gptkb:denosumab
|
| gptkbp:used_for |
osteoporosis
|
| gptkbp:bfsParent |
gptkb:Amgen
|
| gptkbp:bfsLayer |
4
|