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ETRAVIRINE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • In a thorough QT/QTc study in 41 healthy subjects, INTELENCE 200 mg twice daily or 400 mg once daily did not affect the QT/QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
7
42905
Other ADRs
1179
14116100

Odds Ratio = 1.954

Drug Property Information



ATC Code(s):
  • J05AG04 - etravirine
    • J05AG - Non-nucleoside reverse transcriptase inhibitors
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:etravirine
Active Ingredient UNII:0C50HW4FO1
Drugbank ID:DB06414
PubChem Compound:193962
CAS Number:269055-15-4
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
  • 400.0 mg/day J05AG04
Chemical Structure:
SMILE Code:
CC1=CC(=CC(=C1OC2=NC(=NC(=C2Br)N)NC3=CC=C(C=C3)C#N)C)C#N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database.

[Napoli Andrew A,Wood Jennifer J,Coumbis John J,Soitkar Amit M,Seekins Daniel W,Tilson Hugh H]
J Int AIDS Soc.2014 Sep 4;17:19214. doi: 10.7448/IAS.17.1.19214. eCollection 2014. PMID: 25192857

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