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ERIBULIN MESYLATE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Prolongation
- In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with congenital long QT syndrome.
- ADVERSE REACTIONS
- The following adverse reactions are discussed in detail in other sections of the labeling:
- Neutropenia [see WARNINGS AND PRECAUTIONS (5.1)]
- Peripheral neuropathy [see WARNINGS AND PRECAUTIONS (5.2)]
- QT prolongation [see WARNINGS AND PRECAUTIONS (5.4)]
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m2 of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1. The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms.
- PATIENT PACKAGE INSERT
- HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your healthcare provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
9
24083
Other ADRs
6035
38375552
Odds Ratio = 2.377
Drug Property Information
ATC Code(s):
- L01XX41 - eribulin mesylate
- L01XX - Other antineoplastic agents
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:ERIBULIN MESYLATE
Active Ingredient UNII:AV9U0660CW
Drugbank ID:DB08871
PubChem Compound:73425383
CTD ID:C490954
CAS Number:253128-41-5
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
[H][C@@]12CC(=C)[C@]([H])(CC[C@@]3([H])C[C@@H](C)C(=C)[C@@]([H])(C[C@]4([H])O[C@H](C[C@H](O)CN)[C@H](OC)[C@@]4([H])CC(=O)C[C@@]4([H])CC[C@]5([H])O[C@@]6([H])[C@H]7O[C@@]8(C[C@]7([H])O[C@@]6([H])[C@@]([H])(O8)[C@@]5([H])O4)CC1)O3)O2
[H][C@@]12CC(=C)[C@]([H])(CC[C@@]3([H])C[C@@H](C)C(=C)[C@@]([H])(C[C@]4([H])O[C@H](C[C@H](O)CN)[C@H](OC)[C@@]4([H])CC(=O)C[C@@]4([H])CC[C@]5([H])O[C@@]6([H])[C@H]7O[C@@]8(C[C@]7([H])O[C@@]6([H])[C@@]([H])(O8)[C@@]5([H])O4)CC1)O3)O2
Reference
1: Eribulin mesylate use as third-line therapy in patients with metastatic breast cancer (VESPRY): a prospective, multicentre, observational study.
[Adamo Vincenzo,Ricciardi Giuseppina Rosaria Rita,Giuffrida Dario,Scandurra Giuseppa,Russo Antonio,Blasi Livio,Spadaro Pietro,Iacono Carmelo,Soto Parra Hector J,Savarino Antonino,Ferraú Francesco,Zerilli Filippo,Verderame Francesco,Butera Alfredo,Santangelo Carlo,Franchina Veronica,Caruso Michele]Ther Adv Med Oncol,2019 Dec 19;11:1758835919895755. PMID: 31903098
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