Statements (91)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:brand
gptkb:drug |
| gptkbp:activities |
gptkb:Bruton_tyrosine_kinase_inhibitor
|
| gptkbp:appointed_by |
oral capsule
|
| gptkbp:approves |
gptkb:2017
gptkb:FDA gptkb:United_States |
| gptkbp:class |
gptkb:Bruton_tyrosine_kinase_inhibitor
|
| gptkbp:clinical_trial |
Phase 3
ongoing studies completed studies NC T02477696 NC T02039539 NC T02970324 NC T02972840 NC T03414080 |
| gptkbp:contraindication |
hypersensitivity to acalabrutinib
|
| gptkbp:counseling_services |
take with or without food
do not crush or chew avoid live vaccines report signs of bleeding report signs of infection |
| gptkbp:developed_by |
gptkb:temple
|
| gptkbp:dosage_form |
gptkb:beer
|
| gptkbp:effective_date |
FDA approved
2017-10-31 |
| gptkbp:formulation |
oral
|
| gptkbp:has_ability |
100 mg
|
| https://www.w3.org/2000/01/rdf-schema#label |
Calquence
|
| gptkbp:indication |
mantle cell lymphoma
relapsed or refractory mantle cell lymphoma relapsed or refractory chronic lymphocytic leukemia |
| gptkbp:ingredients |
gptkb:acalabrutinib
C24 H26 Cl N5 O2 S |
| gptkbp:interacts_with |
gptkb:warfarin
anticoagulants antiplatelet agents other anticoagulants CY P3 A inducers CY P3 A inhibitors |
| gptkbp:invention |
patented
exclusive rights until 2037 |
| gptkbp:is_atype_of |
L01 X X45
|
| gptkbp:is_available_in |
capsule form
|
| gptkbp:is_monitored_by |
cardiac function
liver function tests complete blood count renal function tests blood counts |
| gptkbp:is_used_for |
treatment of chronic lymphocytic leukemia
treatment of mantle cell lymphoma |
| gptkbp:manager |
oral
|
| gptkbp:manufacturer |
gptkb:temple
|
| gptkbp:market |
gptkb:stock_market_index
prescription only |
| gptkbp:marketed_as |
gptkb:legislation
gptkb:Australia gptkb:United_States gptkb:Native_American_tribe Calquence brand name |
| gptkbp:packaging |
gptkb:beer
|
| gptkbp:pharmacokinetics |
bioavailability 100% (oral)
inhibits B-cell receptor signaling half-life 8-10 hours |
| gptkbp:population |
adults
|
| gptkbp:previous_name |
gptkb:battle
|
| gptkbp:price |
approximately $14,000 per month
|
| gptkbp:products |
gptkb:obinutuzumab
gptkb:venetoclax gptkb:ibrutinib gptkb:idelalisib gptkb:duvelisib |
| gptkbp:requires |
gptkb:theorem
|
| gptkbp:research_focus |
gptkb:healthcare_organization
B-cell malignancies hematological cancers |
| gptkbp:safety_features |
generally well tolerated
|
| gptkbp:side_effect |
gptkb:healthcare_organization
fatigue headache nausea bruising diarrhea |
| gptkbp:storage |
room temperature
store at room temperature keep out of reach of children protect from moisture |
| gptkbp:type_of |
1420477-73-5
|
| gptkbp:type_of_care |
once daily dosing
|
| gptkbp:bfsParent |
gptkb:temple
|
| gptkbp:bfsLayer |
3
|