DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

SUNITINIB MALATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

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

WARNINGS AND PRECAUTIONS
QT Interval Prolongation and Torsade de Pointes
SUTENT can cause QT interval prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes. Torsade de Pointes was observed in <0.1% of patients.
Monitor patients who are at higher risk of developing QT interval prolongation, including patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Consider periodic monitoring of electrocardiograms and electrolytes (i.e., magnesium, potassium) during treatment with SUTENT.
Monitor QT interval more frequently when SUTENT is concomitantly administered with strong CYP3A4 inhibitors or drugs known to prolong QT interval. Consider dose reducing SUTENT [see DOSAGE AND ADMINISTRATION (2.5), DRUG INTERACTIONS (7.2)].
DRUG INTERACTIONS
Drugs that Prolong QT Interval
SUTENT is associated with QTc interval prolongation [see WARNINGS AND PRECAUTIONS (5.3), CLINICAL PHARMACOLOGY (12.2)]. Monitor the QT interval with ECGs more frequently in patients who require treatment with concomitant medications known to prolong the QT interval.
ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling.
Hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.1)]
Cardiovascular Events [see WARNINGS AND PRECAUTIONS (5.2)]
QT Interval Prolongation and Torsade de Pointes [see WARNINGS AND PRECAUTIONS (5.3)]
Hypertension [see WARNINGS AND PRECAUTIONS (5.4)]
Hemorrhagic Events [see WARNINGS AND PRECAUTIONS (5.5)]
Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS (5.6)]
Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS (5.7)]
Proteinuria [see WARNINGS AND PRECAUTIONS (5.8)]
Dermatologic Toxicities [see WARNINGS AND PRECAUTIONS (5.9)]
Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS (5.10)]
Thyroid Dysfunction [see WARNINGS AND PRECAUTIONS (5.11)]
Hypoglycemia [see WARNINGS AND PRECAUTIONS (5.12)]
Osteonecrosis of the Jaw [see WARNINGS AND PRECAUTIONS (5.13)]
Impaired Wound Healing [see WARNINGS AND PRECAUTIONS (5.14)]
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
SUTENT can cause QT interval prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes [see WARNINGS AND PRECAUTIONS (5.3)].
PATIENT COUNSELING INFORMATION
QT Prolongation and Torsade de Pointes
Inform patients of the signs and symptoms of QT prolongation. Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopal symptoms, and cardiac palpitations [see WARNINGS AND PRECAUTIONS (5.3)].
MEDICATION GUIDE
SUTENT may cause serious side effects, including:
Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if you feel dizzy, faint, or have abnormal heartbeats during your treatment with SUTENT

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42844

Other ADRs

36223

14081056

Odds Ratio = 0.617

Drug Property Information

ATC Code(s):

L01XE04 - sunitinib malate

L01XE - Protein kinase inhibitors
L01X - OTHER ANTINEOPLASTIC AGENTS
L01 - ANTINEOPLASTIC AGENTS
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:sunitinib malate

Active Ingredient UNII:LVX8N1UT73

Drugbank ID:DB01268

PubChem Compound:5329102

CAS Number:557795-19-4

Dosage Form(s):capsule

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
CCN(CC)CCNC(=O)C1=C(NC(=C1C)/C=C\2/C3=C(C=CC(=C3)F)NC2=O)C

Reference

COHORT STUDY:

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OTHER REFERENCE(S):

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