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ALECTINIB HYDROCHLORIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamic
  • Cardiac Electrophysiology
  • The ability of alectinib to prolong the QT interval was assessed in 221 patients administered ALECENSA 600 mg twice daily in clinical studies. ALECENSA did not prolong the QTc (QT corrected for heart rate) interval to any clinically relevant extent. One patient had a maximum post-baseline QTcF value of greater than 500 msec, and one patient had a maximum QTcF change from baseline of greater than 60 msec.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
9
24083
Other ADRs
6398
38375189

Odds Ratio = 2.242

Drug Property Information



ATC Code(s):
  • L01ED03 - alectinib hydrochloride
    • L01ED -
    • L01E -
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:ALECTINIB HYDROCHLORIDE
Active Ingredient UNII:P9YY73LO6J
Drugbank ID:DB11363
PubChem Compound:49806720
CTD ID: C582670
PharmGKB:PA166160050
CAS Number:1256580-46-7
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
CCC1=CC2=C(C=C1N1CCC(CC1)N1CCOCC1)C(C)(C)C1=C(C3=CC=C(C=C3N1)C#N)C2=O

Reference

N/A

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