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BETRIXABAN
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- In a study that evaluated the effect of betrixaban on the QT interval, a concentration-dependent increase in the QTc interval was observed. Based on the observed concentration-QTc relationship, a mean (upper 95% CI) QTc prolongation of 4 ms (5 ms) is predicted for 80 mg betrixaban and 13 ms (16 ms) for a 4.7-fold increase in exposure [see Clinical Pharmacology (12.3)].
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- B01AF04 - betrixaban
- B01AF -
- B01A - ANTITHROMBOTIC AGENTS
- B01 - ANTITHROMBOTIC AGENTS
- B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:betrixaban
Active Ingredient UNII:74RWP7W0J9
Drugbank ID:DB12364
PubChem Compound:10275777
CTD ID:C543086
CAS Number:330942-05-7
Dosage Form(s):capsule, gelatin coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
COC1=CC=C(NC(=O)C2=CC=C(C=C2)C(=N)N(C)C)C(=C1)C(=O)NC1=CC=C(Cl)C=N1
COC1=CC=C(NC(=O)C2=CC=C(C=C2)C(=N)N(C)C)C(=C1)C(=O)NC1=CC=C(Cl)C=N1
Reference
1: Absence of QTc prolongation with betrixaban: a randomized, double-blind, placebo- and positive-controlled thorough ECG study.
[Morganroth Joel,Gretler Daniel D,Hollenbach Stanley J,Lambing Joseph L,Sinha Uma]Expert Opin Pharmacother,2013 Jan;14(1):5-13. PMID: 23216423
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