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MELPHALAN


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • Pharmacokinetic-pharmacodynamic analysis showed that Evomela administration increased heart rate-corrected QT interval. The mean change from baseline for QTcF at the mean Cmax of 4701 ng/mL was 8.0 msec. Patients treated with 200 mg/m2 Evomela showed an increase of heart rate (mean change of 7.5 bpm from baseline).

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
6
24086
Other ADRs
16030
38365557

Odds Ratio = 0.597

Drug Property Information



ATC Code(s):
  • L01AA03 - melphalan
    • L01AA0 -
    • L01AA - Nitrogen mustard analogues
    • L01A - ALKYLATING AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:MELPHALAN HYDROCHLORIDE
Active Ingredient UNII:1VXP4V453T
Drugbank ID:DB01042
PubChem Compound:460612
CTD ID:D008558
PharmGKB:PA450354
CAS Number:148-82-3
Dosage Form(s):injection, powder, lyophilized, for solution
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:
N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O

Reference

N/A

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