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REGORAFENIB
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of multiple doses of STIVARGA (160 mg once daily for 21 days) on the QTc interval was evaluated in an open-label, single-arm study in 25 patients with advanced solid tumors. No large changes in the mean QTc interval (i.e., > 20 msec) were detected in the study.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
3
24089
Other ADRs
32400
38349187
Odds Ratio = 0.148
Drug Property Information
ATC Code(s):
- L01EX05 - regorafenib
- L01EX -
- L01E -
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:REGORAFENIB MONOHYDRATE
Active Ingredient UNII:MGN125FS9D
Drugbank ID:DB08896
PubChem Compound:11167602
CTD ID: C559147
CAS Number:755037-03-7
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
CNC(=O)C1=CC(OC2=CC(F)=C(NC(=O)NC3=CC=C(Cl)C(=C3)C(F)(F)F)C=C2)=CC=N1
CNC(=O)C1=CC(OC2=CC(F)=C(NC(=O)NC3=CC=C(Cl)C(=C3)C(F)(F)F)C=C2)=CC=N1
Reference
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[Fukui Taro,Suzuki Koichi,Tamaki Sawako,Abe Iku,Endo Yuhei,Ishikawa Hideki,Kakizawa Nao,Watanabe Fumiaki,Saito Masaaki,Tsujinaka Shingo,Futsuhara Kazushige,Miyakura Yasuyuki,Noda Hiroshi,Rikiyama Toshiki]Surg Case Rep,2019 Oct 21;5(1):145. PMID: 31637554
2: What links BRAF to the heart function? New insights from the cardiotoxicity of BRAF inhibitors in cancer treatment.
[Bronte Enrico,Bronte Giuseppe,Novo Giuseppina,Bronte Fabrizio,Bavetta Maria Grazia,Lo Re Giuseppe,Brancatelli Giuseppe,Bazan Viviana,Natoli Clara,Novo Salvatore,Russo Antonio]Oncotarget,2015 Nov 3;6(34):35589-601. PMID: 26431495
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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