DIQTA 1.0: Drug-Induced QT Prolongation Atlas

BELINOSTAT

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

ADVERSE REACTIONS
[Serious Adverse Reactions]
Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq. The most common serious adverse reactions (> 2%) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure. One treatment-related death associated with hepatic failure was reported in the trial.
One patient with baseline hyperuricemia and bulky disease experienced Grade 4 tumor lysis syndrome during the first cycle of treatment and died due to multi-organ failure. A treatment-related death from ventricular fibrillation was reported in another monotherapy clinical trial with Beleodaq. ECG analysis did not identify QTc prolongation.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

164

38381423

Odds Ratio = 0.0

Drug Property Information

ATC Code(s):

L01XH04 - belinostat

L01XH -
L01X - OTHER ANTINEOPLASTIC AGENTS
L01 - ANTINEOPLASTIC AGENTS
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:BELINOSTAT

Active Ingredient UNII:F4H96P17NZ

Drugbank ID:DB05015

PubChem Compound:6918638

CTD ID: C487081

PharmGKB:

CAS Number:866323-14-0

Dosage Form(s):injection, powder, lyophilized, for solution

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
ONC(=O)\C=C\C1=CC=CC(=C1)S(=O)(=O)NC1=CC=CC=C1

Reference

1: Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome.

[Holkova Beata,Shafer Danielle,Yazbeck Victor,Dave Sandeep,Bose Prithviraj,Tombes Mary Beth,Shrader Ellen,Wan Wen,Bandyopadhyay Dipankar,Weir Caryn,Collins Elizabeth B,Garnett Amanda,Kmieciak Maciej,Roberts John D,Garcia-Manero Guillermo,Grant Steven]
Leuk Lymphoma,2021 May;62(5):1187-1194. PMID: 33356689

2: Phase II study of the histone deacetylase inhibitor belinostat (PXD101) for the treatment of myelodysplastic syndrome (MDS).

[Cashen Amanda,Juckett Mark,Jumonville Alcee,Litzow Mark,Flynn P J,Eckardt John,LaPlant Betsy,Laumann Kristina,Erlichman Charles,DiPersio John]
Ann Hematol,2012 Jan;91(1):33-8. PMID: 21538061

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