DIQTA 1.0: Drug-Induced QT Prolongation Atlas

ARSENIC TRIOXIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:5.0

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

BOXED WARNING
WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE'S
Cardiac Conduction Abnormalities: Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering arsenic trioxide, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer arsenic trioxide to patients with a ventricular arrhythmia or prolonged QTc interval. Withhold arsenic trioxide until resolution and resume at reduced dose for QTc prolongation [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.2)].
WARNINGS AND PRECAUTIONS
Cardiac Conduction Abnormalities
Patients treated with arsenic trioxide can develop QTc prolongation, torsade de pointes, and complete atrioventricular block. In the clinical trial of patients with relapsed or refractory APL treated with arsenic trioxide monotherapy, 40% had at least one ECG tracing with a QTc interval greater than 500 msec. A prolonged QTc was observed between 1 and 5 weeks after start of arsenic trioxide infusion, and it usually resolved by 8 weeks after arsenic trioxide infusion. There are no data on the effect of arsenic trioxide on the QTc interval during the infusion of the drug.
The risk of torsade de pointes is related to the extent of QTc prolongation, concomitant administration of QTc prolonging drugs, a history of torsade de pointes, pre-existing QTc interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. The risk may be increased when arsenic trioxide is coadministered with medications that can lead to electrolyte abnormalities (such as diuretics or amphotericin B) [see DRUG INTERACTIONS (7)].
Prior to initiating therapy with arsenic trioxide, assess the QTc interval by electrocardiogram, correct pre-existing electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer arsenic trioxide to patients with a ventricular arrhythmia or prolonged QTc. If possible, discontinue drugs that are known to prolong the QTc interval. If it is not possible to discontinue the interacting drug, perform cardiac monitoring frequently [see DRUG INTERACTIONS (7)]. During arsenic trioxide therapy, maintain potassium concentrations above 4 mEq/L and magnesium concentrations above 1.8 mg/dL. Monitor ECG weekly and more frequently for clinically unstable patients.
For patients who develop a QTc Framingham greater than 450 msec for men or greater than 460 msec for women, withhold arsenic trioxide and any medication known to prolong the QTc interval. Correct electrolyte abnormalities. When the QTc normalizes and electrolyte abnormalities are corrected, resume arsenic trioxide at a reduced dose [see DOSAGE AND ADMINISTRATION (2.3)].
DRUG INTERACTIONS
Drugs That Can Prolong the QT/QTc Interval
Concomitant use of these drugs and arsenic trioxide may increase the risk of serious QT/QTc interval prolongation [see WARNINGS AND PRECAUTIONS (5.1)]. Discontinue or replace with an alternative drug that does not prolong the QT/QTc interval while the patient is using arsenic trioxide. Monitor ECGs more frequently in patients when it is not feasible to avoid concomitant use.
[Drugs That Can Lead to Electrolyte Abnormalities]
Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation [see WARNINGS AND PRECAUTIONS (5.1)]. Avoid concomitant use of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and arsenic trioxide.
[Drugs That Can Lead to Hepatotoxicity]
Concomitant use of these drugs and arsenic trioxide injection may increase the risk of serious hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.4)]. Discontinue or replace with an alternative drug that does not cause hepatotoxicity while the patient is using arsenic trioxide injection. Monitor liver function tests more frequently in patients when it is not feasible to avoid concomitant use.
DOSAGE AND ADMINISTRATION
ADVERSE REACTIONS
Clinical Trials Experience
The most common adverse reactions (> 30%) were nausea, cough, fatigue, pyrexia, headache, abdominal pain, vomiting, tachycardia, diarrhea, dyspnea, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QTc prolongation, rigors, sore throat, arthralgia, paresthesia, and pruritus.
[Postmarketing Experience]
Cardiac disorders: Ventricular extrasystoles in association with QT prolongation, ventricular tachycardia in association with QT prolongation, including torsade de pointes, atrioventricular block, and congestive heart failure
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
In a single-arm trial of arsenic trioxide (0.15 mg/kg daily), 16 of 40 patients (40%) had a QTc interval greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after arsenic trioxide infusion, and then returned towards baseline by the end of 8 weeks after arsenic trioxide infusion.
PATIENT COUNSELING INFORMATION
Cardiac Conduction Abnormalities
Advise patients that arsenic trioxide may cause ECG abnormalities, including QT prolongation. If extreme, this prolongation has the potential to cause fainting, irregular heartbeat, or more serious side effects. Advise patients to immediately report any of these symptoms. Advise patients to provide a complete list of current medications as caution should be taken when arsenic trioxide injection is coadministered with other medications that can cause QT prolongation or lead to electrolyte abnormalities [see WARNINGS AND PRECAUTIONS (5.2) and DRUG INTERACTIONS (7)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

130

23962

Other ADRs

4253

38377334

Odds Ratio = 48.956

Drug Property Information

ATC Code(s):

L01XX27 - arsenic trioxide

L01XX - Other antineoplastic agents
L01X - OTHER ANTINEOPLASTIC AGENTS
L01 - ANTINEOPLASTIC AGENTS
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:ARSENIC TRIOXIDE

Active Ingredient UNII:S7V92P67HO

Drugbank ID:DB01169

PubChem Compound:261004

CTD ID:D000077237

PharmGKB:PA448486

CAS Number:1327-53-3

Dosage Form(s):injection, solution

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
O=[As]O[As]=O

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