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POMALIDOMIDE
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 QTc prolongation potential of pomalidomide was evaluated in a single center, randomized, double-blind crossover study (N=72) using 4 mg pomalidomide, 20 mg pomalidomide, placebo, and 400 mg moxifloxacin (positive control). No significant QTc prolongation effect of pomalidomide was observed following pomalidomide doses of 4 and 20 mg.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
7
24085
Other ADRs
86205
38295382
Odds Ratio = 0.13
Drug Property Information
ATC Code(s):
- L04AX06 - pomalidomide
- L04AX0 -
- L04AX - Other immunosuppressants
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:POMALIDOMIDE
Active Ingredient UNII:D2UX06XLB5
Drugbank ID:DB08910
PubChem Compound:134780
CTD ID: C467566
CAS Number:19171-19-8
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
- 3.0 mg/day L04AX06
Chemical Structure: 
SMILE Code:
NC1=CC=CC2=C1C(=O)N(C1CCC(=O)NC1=O)C2=O
NC1=CC=CC2=C1C(=O)N(C1CCC(=O)NC1=O)C2=O
Reference
1: A Phase 1, double-blind, 4-period crossover study to investigate the effects of pomalidomide on QT interval in healthy male subjects.
[Mondal Sabiha A,Assaf Mahmoud,Liu Liangang,O'Mara Edward]Cancer Chemother Pharmacol,2016 Feb;77(2):251-8. PMID: 26754679
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