DIQTA 1.0: Drug-Induced QT Prolongation Atlas

ABIRATERONE ACETATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:4.0

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

WARNINGS AND PRECAUTIONS
Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess
Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. In postmarketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking abiraterone acetate.
ADVERSE REACTIONS
Post Marketing Experience
Cardiac Disorders: QT prolongation and Torsades de Pointes (observed in patients who developed hypokalemia or had underlying cardiovascular conditions).
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
In a multi-center, open-label, single-arm trial, 33 patients with metastatic CRPC received a dose of 1,000 mg once daily orally of another abiraterone acetate product at least 1 hour before or 2 hours after a meal in combination with a different corticosteroid orally twice daily. Assessments up to Cycle 2 Day 2 showed no large changes in the QTc interval (i.e., >20 ms) from baseline. However, small increases in the QTc interval (i.e., <10 ms) due to abiraterone acetate cannot be excluded due to study design limitations.
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information)
Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions
Inform patients that YONSA is associated with hypertension, hypokalemia, and peripheral edema that may lead to QT prolongation and Torsades de Pointes in patients who develop hypokalemia while taking YONSA. Advise patients that their blood pressure, serum potassium and signs and symptoms of fluid retention will be monitored clinically at least monthly. Advise patients to adhere to corticosteroids and to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider [see Warnings and Precautions (5.1)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24072

Other ADRs

44601

38336986

Odds Ratio = 0.715

Drug Property Information

ATC Code(s):

L02BX03 - abiraterone acetate

L02BX - Other hormone antagonists and related agents
L02B - HORMONE ANTAGONISTS AND RELATED AGENTS
L02 - ENDOCRINE THERAPY
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:ABIRATERONE ACETATE

Active Ingredient UNII:EM5OCB9YJ6

Drugbank ID:DB05812

PubChem Compound:132971

CTD ID: D000069501

PharmGKB:PA166123407

CAS Number:154229-19-3

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

1000.0 mg/day L02BX03

Chemical Structure:

SMILE Code:
[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C

Reference

1: Syncope due to non-sustained episodes of Torsade de Pointes associated to androgen-deprivation therapy use: a case presentation.

[Morales Ximena,Garnica Diego,Isaza Daniel,Isaza Nicolas,Durán-Torres Felipe]
BMC Cardiovasc Disord,2021 Mar 12;21(1):136. PMID: 33711933

2: Abiraterone acetate-induced life-threatening torsade de pointes.

[Rodieux Frederique,Nieto Nathalie,Sunthorn Henri,John Gregor,Escher Monica]
Ann Pharmacother,2015 Jan;49(1):152-3. PMID: 25524931

3: Effect of abiraterone acetate plus prednisone on the QT interval in patients with metastatic castration-resistant prostate cancer.

[Tolcher A W,Chi K N,Shore N D,Pili R,Molina A,Acharya M,Kheoh T,Jiao J J,Gonzalez M,Trinh A,Pankras C,Tran N]
Cancer Chemother Pharmacol,2012 Aug;70(2):305-13. PMID: 22752297

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