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AXITINIB
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- The effect of a single oral dose of INLYTA (5 mg) in the absence and presence of 400 mg ketoconazole on the QTc interval was evaluated in a randomized, single-blinded, two-way crossover study in 35 healthy subjects. No large changes in mean QTc interval (i.e., >20 ms) from placebo were detected up to 3 hours post-dose. However, small increases in mean QTc interval (i.e., <10 ms) cannot be ruled out.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
9
24083
Other ADRs
23291
38358296
Odds Ratio = 0.616
Drug Property Information
ATC Code(s):
- L01EK01 - axitinib
- L01EK -
- L01E -
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:AXITINIB
Active Ingredient UNII:C9LVQ0YUXG
Drugbank ID:DB06626
PubChem Compound:6450551
CTD ID: D000077784
PharmGKB:PA164924493
CAS Number:319460-85-0
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1
CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=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 axitinib on the QT interval in healthy volunteers.
[Ruiz-Garcia Ana,Houk Brett E,Pithavala Yazdi K,Toh Melvin,Sarapa Nenad,Tortorici Michael A]Cancer Chemother Pharmacol,2015 Mar;75(3):619-28. PMID: 25589220
3: QTc interval prolongation with vascular endothelial growth factor receptor tyrosine kinase inhibitors.
[Ghatalia P,Je Y,Kaymakcalan M D,Sonpavde G,Choueiri T K]Br J Cancer,2015 Jan 20;112(2):296-305. PMID: 25349964
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