ARSENIC TRIOXIDE injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)

Предлага се от:

STI Pharma LLC

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Arsenic Trioxide for Injection is contraindicated in patients who are hypersensitive to arsenic. Risk Summary Based on the mechanism of action [see Clinical Pharmacology ( 12.1) ] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. Arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m 2 basis ( see Data ). A related trivalent arsenic, sodium arsenite, produced teratogenicity when

Каталог на резюме:

Arsenic Trioxide for injection is supplied as a sterile, clear, odorless solution in 10mL glass, single-dose vials. NDC 54879-027-10 10 mg/10 mL (1 mg/mL) vials in a bundle of ten vials. Store at 25ºC (77ºF); excursions permitted to 15 - 30ºC (59 - 86ºF). See USP Controlled Room Temperature. Do not freeze. Arsenic Trioxide for Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ARSENIC TRIOXIDE- ARSENIC TRIOXIDE INJECTION, SOLUTION
STI PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ARSENIC TRIOXIDE INJECTION, FOR INTRAVENOUS ADMINISTRATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARSENIC TRIOXIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARSENIC
TRIOXIDE.
INITIAL U.S. APPROVAL: 2000
WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS TREATED WITH ARSENIC TRIOXIDE INJECTION MAY DEVELOP
DIFFERENTIATION
SYNDROME, WHICH CAN BE FATAL. IF SYMPTOMS OCCUR, INITIATE HIGH-DOSE
STEROIDS
IMMEDIATELY AND MONITOR HEMODYNAMICS. ( 5.1)
ARSENIC TRIOXIDE INJECTION CAN CAUSE QT INTERVAL PROLONGATION AND
VENTRICULAR
ARRHYTHMIA, WHICH CAN BE FATAL. BEFORE ADMINISTERING ARSENIC TRIOXIDE
INJECTION,
ASSESS THE QT INTERVAL, CORRECT ELECTROLYTE ABNORMALITIES, AND
CONSIDER DISCONTINUING
DRUGS KNOWN TO PROLONG QT INTERVAL. DO NOT ADMINISTER ARSENIC TRIOXIDE
INJECTION TO
PATIENTS WITH VENTRICULAR ARRHYTHMIA OR PROLONGED QTCF. ( 2.3, 5.2)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1) ………….…01/2018
Warnings and Precautions ( 5.1, 5.2, 5.3) …….01/2018
INDICATIONS AND USAGE
Arsenic trioxide injection is an arsenical indicated:
For induction of remission and consolidation in patients with APL who
are refractory to, or have relapsed
from, retinoid and anthracycline chemotherapy, and whose APL is
characterized by the presence of the
t(15;17) translocation or PML/RAR-alpha gene expression. ( 1.2)
DOSAGE AND ADMINISTRATION
Relapsed or refractory APL:
Induction : 0.15 mg/kg intravenously daily until bone marrow
remission. Do not exceed 60 doses for
total induction. ( 2.2)
Consolidation: 0.15 mg/kg intravenously daily for 25 doses over a
period up to 5 weeks. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Injectable solution for intravenous administration supplied as 10
mg/10 ml of arsenic trioxide in single-dose
vials. ( 3)
CONTRAINDICATIONS
Hypersensitivity to arsenic.