Statements (133)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:approves |
gptkb:Waldenström's_macroglobulinemia
gptkb:2013 gptkb:Brazil gptkb:FDA gptkb:Israel gptkb:Japan gptkb:Oncology gptkb:Singapore gptkb:Switzerland mantle cell lymphoma |
| gptkbp:atccode |
L01 XX32
|
| gptkbp:casnumber |
936563-96-1
|
| gptkbp:chemical_formula |
C19 H24 N2 O2 S
|
| gptkbp:class |
gptkb:Atom
targeted therapy antineoplastic agent |
| gptkbp:clinical_trial |
gptkb:Waldenström's_macroglobulinemia
gptkb:Oncology ongoing Phase 3 mantle cell lymphoma NCT02477696 NCT02264574 NCT01805924 NCT02141257 NCT02004655 NCT02101853 NCT02343120 |
| gptkbp:clinical_use |
combination therapy
monotherapy first-line treatment for CLL relapsed or refractory CLL treatment for MCL treatment for SLL treatment for WM treatment for chronic graft-versus-host disease treatment for marginal zone lymphoma |
| gptkbp:contraindication |
active bleeding disorders
severe hepatic impairment concomitant use with strong CYP3 A inhibitors concomitant use of strong CYP3 A inhibitors |
| gptkbp:developed_by |
gptkb:Abb_Vie
|
| gptkbp:discovery |
gptkb:Pharmacyclics
|
| gptkbp:discovery_year |
gptkb:2003
|
| gptkbp:dosage_form |
gptkb:tablet
gptkb:capsule 140 mg capsule 280 mg capsule 420 mg capsule |
| gptkbp:drug_interactions |
gptkb:warfarin
anticoagulants antiplatelet agents |
| gptkbp:effective_date |
2013-11-13
|
| gptkbp:excretion |
urine
feces |
| gptkbp:financial_support |
available for education
available for financial assistance available for adherence support |
| gptkbp:formulation |
gptkb:tablet
gptkb:capsule ibrutinib 140 mg ibrutinib 280 mg ibrutinib 420 mg ibrutinib 560 mg ibrutinib 840 mg |
| gptkbp:healthcare |
gptkb:Yes
|
| https://www.w3.org/2000/01/rdf-schema#label |
Imbruvica
|
| gptkbp:indication |
B-cell malignancies
|
| gptkbp:ingredients |
gptkb:ibrutinib
|
| gptkbp:invention |
2026
patented |
| gptkbp:manufacturer |
gptkb:Abb_Vie
|
| gptkbp:marketed_as |
gptkb:ibrutinib
gptkb:Australia gptkb:Canada gptkb:European_Union gptkb:United_States gptkb:Imbruvica |
| gptkbp:mechanism_of_action |
gptkb:Bruton_tyrosine_kinase_inhibitor
|
| gptkbp:metabolism |
gptkb:CYP3_A4
|
| gptkbp:packaging |
blister packs
bottles of 30 capsules |
| gptkbp:patient_population |
adults
pediatric patients |
| gptkbp:pharmacokinetics |
bioavailability 100% (oral)
bioavailability 100% after oral administration half-life 4-5 hours metabolized by CYP3 A4 |
| gptkbp:previous_name |
No
|
| gptkbp:price |
approximately $14,000 per month
|
| gptkbp:provides_guidance_on |
included in ASCO guidelines
included in NCCN guidelines |
| gptkbp:research_and_development |
ongoing studies for other cancers
|
| gptkbp:research_areas |
oncology
hematology immunology |
| gptkbp:research_institutes |
collaborated with academic institutions
collaborated with hospitals |
| gptkbp:route_of_administration |
oral
|
| gptkbp:safety_labeling_changes |
gptkb:2019
gptkb:2020 gptkb:2021 gptkb:2022 gptkb:2023 |
| gptkbp:safety_measures |
risk of bleeding
risk of infections risk of cardiac arrhythmias risk of tumor lysis syndrome |
| gptkbp:side_effect |
gptkb:anemia
fatigue nausea hypertension bruising diarrhea rash thrombocytopenia neutropenia increased risk of infection arthralgia |
| gptkbp:storage |
store at room temperature
keep away from moisture |
| gptkbp:strength |
140 mg
280 mg 420 mg |
| gptkbp:type_of_care |
important for treatment efficacy
|
| gptkbp:used_for |
gptkb:Waldenström's_macroglobulinemia
gptkb:Oncology mantle cell lymphoma treatment of certain types of cancer |
| gptkbp:bfsParent |
gptkb:Johnson_&_Johnson
gptkb:Abb_Vie |
| gptkbp:bfsLayer |
4
|