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LENALIDOMIDE
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 lenalidomide on the QTc interval was evaluated in 60 healthy male subjects in a thorough QT study. At a dose two times the maximum recommended dose, lenalidomide did not prolong the QTc interval. The largest upper bound of the two-sided 90% CI for the mean differences between lenalidomide and placebo was below 10 ms.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
85
24007
Other ADRs
450709
37930878
Odds Ratio = 0.298
Drug Property Information
ATC Code(s):
- L04AX04 - lenalidomide
- L04AX - Other immunosuppressants
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:LENALIDOMIDE
Active Ingredient UNII:F0P408N6V4
Drugbank ID:DB00480
PubChem Compound:216326
CTD ID:D000077269
PharmGKB:PA162363968
CAS Number:191732-72-6
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
- 10.0 mg/day L04AX04
Chemical Structure: 
SMILE Code:
NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Reference
1: Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.
[Moreland-Head Lindsay N,Coons James C,Seybert Amy L,Gray Matthew P,Kane-Gill Sandra L]J Cardiovasc Pharmacol Ther,2021 Jan 6;1074248420984082. PMID: 33403858
2: Clinical Pharmacokinetics and Pharmacodynamics of Lenalidomide.
[Chen Nianhang,Zhou Simon,Palmisano Maria]Clin Pharmacokinet,2017 Feb;56(2):139-152. PMID: 27351179
3: Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study.
[Ogura Michinori,Imaizumi Yoshitaka,Uike Naokuni,Asou Norio,Utsunomiya Atae,Uchida Toshiki,Aoki Tomohiro,Tsukasaki Kunihiro,Taguchi Jun,Choi Ilseung,Maruyama Dai,Nosaka Kisato,Chen Nianhang,Midorikawa Shuichi,Ohtsu Tomoko,Tobinai Kensei]Lancet Haematol,2016 Mar;3(3):e107-18. PMID: 26947199
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