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PIRFENIDONE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- Relative to placebo, the maximum mean change from baseline in study-specific QT interval was 3.2 milliseconds (ms) and 2.2 ms for ESBRIET 2403 mg/day and 4005 mg/day, respectively. No volunteer had a QTc interval greater than 480 ms or change from baseline greater than 60 ms. Although there was no evidence that ESBRIET prolonged the QTc interval in this study, a definitive conclusion may not be drawn as the positive control (moxifloxacin) did not perform as expected in this study, and ESBRIET at 4005 mg/day (1.7 times the maximum recommended dose) did not cover the maximum pirfenidone exposure increase with co-administration of fluvoxamine, a strong CYP1A2 inhibitor.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
57365
38324222
Odds Ratio = 0.028
Drug Property Information
ATC Code(s):
- L04AX05 - pirfenidone
- L04AX - Other immunosuppressants
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:PIRFENIDONE
Active Ingredient UNII:D7NLD2JX7U
Drugbank ID:DB04951
PubChem Compound:40632
CTD ID:C093844
CAS Number:53179-13-8
Dosage Form(s):capsule; tablet, coated
Route(s) Of Administrator:oral
Daily Dose:
- 2400.0 mg/day L04AX05
Chemical Structure: 
SMILE Code:
CC1=CN(C(=O)C=C1)C1=CC=CC=C1
CC1=CN(C(=O)C=C1)C1=CC=CC=C1
Reference
N/A
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