Statements (54)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:administered_by |
intravenous infusion
|
| gptkbp:approves |
gptkb:2011
gptkb:FDA |
| gptkbp:chemical_formula |
C6400 H9924 N1716 O1984 S46
|
| gptkbp:clinical_trial |
Phase III
BLISS-52 BLISS-76 BLISS-NEA |
| gptkbp:clinical_use |
monotherapy or in combination with other therapies
|
| gptkbp:contraindication |
severe infections
hypersensitivity to belimumab |
| gptkbp:developed_by |
Human Genome Sciences
|
| gptkbp:dosage_form |
lyophilized powder for reconstitution
|
| gptkbp:formulation |
solution for injection
|
| https://www.w3.org/2000/01/rdf-schema#label |
Benlysta
|
| gptkbp:indication |
active lupus nephritis
lupus arthritis lupus skin manifestations |
| gptkbp:ingredients |
belimumab
|
| gptkbp:is_monitored_by |
monitoring for psychiatric symptoms
regular assessment of infection risk |
| gptkbp:market |
ongoing
|
| gptkbp:market_launch |
2011 in the US
2012 in Europe 2013 in Canada 2014 in Australia |
| gptkbp:marketed_as |
gptkb:Glaxo_Smith_Kline
|
| gptkbp:mechanism_of_action |
B-lymphocyte stimulator (BLy S) inhibitor
|
| gptkbp:patient_population |
adults
children over 5 years old |
| gptkbp:pharmacokinetics |
half-life of approximately 19 days
inhibits B-cell activation |
| gptkbp:regulatory_compliance |
gptkb:Health_Canada
gptkb:TGA_Australia gptkb:European_Medicines_Agency |
| gptkbp:research_focus |
autoimmune disease therapies
lupus treatment advancements biologic therapy development |
| gptkbp:route_of_administration |
subcutaneous injection
|
| gptkbp:shelf_life |
24 months
|
| gptkbp:side_effect |
gptkb:depression
fatigue headache nausea increased risk of infections injection site reactions anaphylaxis infusion reactions |
| gptkbp:storage |
refrigerated
|
| gptkbp:used_for |
gptkb:systemic_lupus_erythematosus
|
| gptkbp:weight |
144 k Da
|
| gptkbp:bfsParent |
gptkb:GSK
|
| gptkbp:bfsLayer |
4
|