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UPADACITINIB
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- At 6 times the mean maximum exposure of the 15 mg once daily dose, there was no clinically relevant effect on the QTc interval.
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):
- L04AA44 - upadacitinib
- L04AA - Selective immunosuppressants
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:upadacitinib
Active Ingredient UNII:4RA0KN46E0
Drugbank ID:DB15091
PubChem Compound:N/ADIR Classification
CTD ID:C000613732
CAS Number:1310726-60-3
Dosage Form(s):tablet, extended release
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
CC[C@@H]1CN(C[C@@H]1C1=CN=C2C=NC3=C(C=CN3)N12)C(=O)NCC(F)(F)F
CC[C@@H]1CN(C[C@@H]1C1=CN=C2C=NC3=C(C=CN3)N12)C(=O)NCC(F)(F)F
Reference
1: Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity.
[Mohamed Mohamed-Eslam F,Zeng Jiewei,Jiang Ping,Hosmane Balakrishna,Othman Ahmed A]Clin Pharmacol Ther,2018 May;103(5):836-842. PMID: 28762476
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