DIQTA 1.0: Drug-Induced QT Prolongation Atlas

ENZALUTAMIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

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 enzalutamide 160 mg/day at steady-state on the QTc interval was evaluated in 796 patients with metastatic CRPC. No large difference (i.e., greater than 20 ms) was observed between the mean QT interval change from baseline in patients treated with XTANDI and that in patients treated with placebo, based on the Fridericia correction method. However, small increases in the mean QTc interval (i.e., less than 10 ms) due to enzalutamide cannot be excluded due to limitations of the study design.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24050

Other ADRs

116452

38265135

Odds Ratio = 0.574

Drug Property Information

ATC Code(s):

L02BB04 - enzalutamide

L02BB - Anti-androgens
L02B - HORMONE ANTAGONISTS AND RELATED AGENTS
L02 - ENDOCRINE THERAPY
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:ENZALUTAMIDE

Active Ingredient UNII:93T0T9GKNU

Drugbank ID:DB08899

PubChem Compound:15951529

CTD ID: C540278

PharmGKB:

CAS Number:915087-33-1

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

160.0 mg/day L02BB04

Chemical Structure:

SMILE Code:
CNC(=O)C1=C(F)C=C(C=C1)N1C(=S)N(C(=O)C1(C)C)C1=CC=C(C#N)C(=C1)C(F)(F)F

Reference

1: [Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis].

[Scailteux Lucie-Marie,Lacroix Clémence,Bergeron Sandrine,Despas Fabien,Sassier Marion,Triquet Louise,Picard Sylvie,Oger Emmanuel,Polard Elisabeth,et le réseau français des Centres régionaux de pharmacovigilance]
Therapie,2020 Dec 13;S0040-5957(20)30229-8. PMID: 33376005

2: Dual Blockade of c-MET and the Androgen Receptor in Metastatic Castration-resistant Prostate Cancer: A Phase I Study of Concurrent Enzalutamide and Crizotinib.

[Tripathi Abhishek,Supko Jeffrey G,Gray Kathryn P,Melnick Zachary J,Regan Meredith M,Taplin Mary-Ellen,Choudhury Atish D,Pomerantz Mark M,Bellmunt Joaquim,Yu Channing,Sun Zijie,Srinivas Sandy,Kantoff Philip W,Sweeney Christopher J,Harshman Lauren C]
Clin Cancer Res,2020 Dec 1;26(23):6122-6131. PMID: 32943461

3: Androgenic effects on ventricular repolarization: A translational study from the international pharmacovigilance database to iPSC-cardiomyocytes.

[Salem J E,Yang T,Moslehi J J,Waintraub X,Gandjbakhch E,Bachelot A,Hidden-Lucet F,Hulot J S,Knollmann B C,Lebrun-Vignes B,Funck-Brentano C,Glazer A M,Roden D M]
Ann Endocrinol (Paris),2020 Feb 29;S0003-4266(20)30031-7. PMID: 32171470

4: Androgenic Effects on Ventricular Repolarization: A Translational Study From the International Pharmacovigilance Database to iPSC-Cardiomyocytes.

[Salem Joe-Elie,Yang Tao,Moslehi Javid J,Waintraub Xavier,Gandjbakhch Estelle,Bachelot Anne,Hidden-Lucet Francoise,Hulot Jean-Sebastien,Knollmann Bjorn C,Lebrun-Vignes Benedicte,Funck-Brentano Christian,Glazer Andrew M,Roden Dan M]
Circulation,2019 Sep 24;140(13):1070-1080. PMID: 31378084

Search for drugs: