DIQTA 1.0: Drug-Induced QT Prolongation Atlas

TEMSIROLIMUS INJECTION

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

CLINICAL PHARMACOLOGY
Pharmacodynamics
Effects on Electrocardiogram: There were no clinically relevant QT changes observed at the recommended dose for temsirolimus injection. In a randomized, single-blinded, crossover study, 58 healthy subjects received temsirolimus injection 25 mg, placebo, and a single oral dose of moxifloxacin 400 mg. A supratherapeutic temsirolimus injection dose was not studied in this randomized QT trial. The largest difference between the upper bound 2-sided 90% CI for the mean difference between temsirolimus injection and placebo-corrected QT interval was less than 10 ms. In a different trial in 69 patients with a hematologic malignancy, temsirolimus injection doses up to 175 mg were studied. No patient with a normal QTcF at baseline had an increase in QTcF >60 ms. Additionally, there were no patients with a QTcF interval greater than 500 ms.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

8479

38373108

Odds Ratio = 0.0

Drug Property Information

ATC Code(s):

L01EG01 - temsirolimus injection

L01EG0 -
L01EG -
L01E -
L01 - ANTINEOPLASTIC AGENTS
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:TEMSIROLIMUS

Active Ingredient UNII:624KN6GM2T

Drugbank ID:DB06287

PubChem Compound:23724530

CTD ID: C401859

PharmGKB:PA164746890

CAS Number:162635-04-3

Dosage Form(s):kit

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
OCC(C)(CO)C(=O)O[C@@H]1CC[C@@H](C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@@H](OC)C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@H]3C(=O)O2)C[C@H]1OC

Reference

N/A