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NINTEDANIB
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 in renal cell cancer patients, QT/QTc measurements were recorded and showed that a single oral dose of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered twice daily for 15 days did not prolong the QTcF interval.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
42201
38339386
Odds Ratio = 0.038
Drug Property Information
ATC Code(s):
- L01EX09 - nintedanib
- L01EX -
- L01E -
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:NINTEDANIB ESYLATE
Active Ingredient UNII:42F62RTZ4G
Drugbank ID:DB09079
PubChem Compound:9809715
CTD ID: C530716
CAS Number:656247-17-5
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
COC(=O)C1=CC=C2C(NC(=O)\C2=C(/NC2=CC=C(C=C2)N(C)C(=O)CN2CCN(C)CC2)C2=CC=CC=C2)=C1
COC(=O)C1=CC=C2C(NC(=O)\C2=C(/NC2=CC=C(C=C2)N(C)C(=O)CN2CCN(C)CC2)C2=CC=CC=C2)=C1
Reference
1: Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit.
[Shah Rashmi R,Morganroth Joel]Drug Saf,2015 Aug;38(8):693-710. PMID: 26008987
2: Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study.
[Eisen Tim,Shparyk Yaroslav,Macleod Nicholas,Jones Robert,Wallenstein Gudrun,Temple Graham,Khder Yasser,Dallinger Claudia,Studeny Matus,Loembe Arsene-Bienvenu,Bondarenko Igor]Invest New Drugs,2013 Oct;31(5):1283-93. PMID: 23625328
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