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EVEROLIMUS


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • In a randomized, placebo-controlled, cross-over study, 59 healthy subjects were administered a single oral dose of Everolimus (20 mg and 50 mg) and placebo. Everolimus at single doses up to 50 mg did not prolong the QT/QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
18
24074
Other ADRs
113324
38268263

Odds Ratio = 0.253

Drug Property Information



ATC Code(s):
  • L04AA18 - everolimus
    • L04AA1 -
    • L04AA - Selective immunosuppressants
    • L04A - IMMUNOSUPPRESSANTS
    • L04 - IMMUNOSUPPRESSANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L01EG02 - everolimus
    • L01EG -
    • L01E -
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:EVEROLIMUS
Active Ingredient UNII:9HW64Q8G6G
Drugbank ID:DB01590
PubChem Compound:6442177
CTD ID: D000068338
PharmGKB:PA164746311
CAS Number:159351-69-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
  • 1.5 mg/day L04AA18
Chemical Structure:
SMILE Code:
[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC

Reference

1: Phase I/II trial of exemestane, ribociclib, and everolimus in women with HR+/HER2- advanced breast cancer after progression on CDK4/6 inhibitors (TRINITI-1).

[Bardia Aditya,Hurvitz Sara A,DeMichele Angela,Clark Amy S,Zelnak Amelia,Yardley Denise,Karuturi Meghan Sri,Sanft Tara,Blau Sibel,Hart Lowell,Ma Cynthia X,Rugo Hope S,Purkayastha Das,Moulder-Thompson Stacy]
Clin Cancer Res,2021 Mar 15;clincanres.2114.2020. PMID: 33722897

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