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DAROLUTAMIDE


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 darolutamide (600 mg twice daily) on the QTc interval was evaluated in a subgroup of 500 patients in the ARAMIS study. No large mean increase in QTc (i.e., > 20 ms) was detected.

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):
  • L02BB06 - darolutamide
    • L02BB - Anti-androgens
    • L02B - HORMONE ANTAGONISTS AND RELATED AGENTS
    • L02 - ENDOCRINE THERAPY
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:DAROLUTAMIDE
Active Ingredient UNII:X05U0N2RCO
Drugbank ID:DB12941
PubChem Compound:67171867
CTD ID:C000607739
PharmGKB:
CAS Number:1297538-32-9
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
C[C@@H](CN1C=CC(=N1)C1=CC=C(C#N)C(Cl)=C1)NC(=O)C1=NNC(=C1)C(C)O

Reference

N/A

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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

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