TOTECT- dexrazoxane hydrochloride injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)

Доступна с:

Clinigen Limited

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Extravasation Totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. Cardiomyopathy Totect is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2)] . None. Risk Summary Based on findings from animal studies and its mechanism of action, Totect can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available data with Totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at mat

Обзор продуктов:

Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder. NDC 76310-110-01: Carton of 1 vial of Totect. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use. Follow special handling and disposal procedures [see Dosage and Administration (2.4)] .1

Статус Авторизация:

New Drug Application

Характеристики продукта

TOTECT- DEXRAZOXANE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
CLINIGEN LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOTECT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOTECT.
TOTECT (DEXRAZOXANE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2020
Dosage and Administration (2.1 - 2.5) 11/2020
Warnings and Precautions (5.1 - 5.4) 11/2020
INDICATIONS AND USAGE
Totect is a cytoprotective agent indicated for:
Treatment of extravasation resulting from intravenous anthracycline
chemotherapy. (1)
Reducing the incidence and severity of cardiomyopathy associated with
doxorubicin administration in
women with metastatic breast cancer who have received a cumulative
doxorubicin dose of 300 mg/m
and who will continue to receive doxorubicin therapy to maintain tumor
control. Do not use Totect with
doxorubicin initiation. (1, 5.2)
DOSAGE AND ADMINISTRATION
Reconstitute and further dilute Totect before use. (2.4)
_Extravasation:_ administer Totect by intravenous infusion over 1
to 2 hours once daily for 3 consecutive
days. (2.1)
Initiate the first infusion as soon as possible and within the first
six hours after extravasation. (2.1)
Recommended doseMaximum daily dose
Day one: 1000 mg/m 2000 mg
Day two: 1000 mg/m 2000 mg
Day three: 500 mg/m 1000 mg
_Cardiomyopathy:_ administer Totect by intravenous infusion over 15
minutes until discontinuation of
doxorubicin. (2.2)
Do NOT administer via intravenous push. (2.5)
The recommended dosage ratio of Totect to doxorubicin is 10:1, (e.g.
500 mg/m² Totect to 50 mg/m²
doxorubicin). (2.2)
Do not administer doxorubicin before Totect. (2.5)
Administer doxorubicin within 30 minutes after the completion of
Totect infusion. (2.5)
_Dose Modifications:_ reduce dose by 50% for patients with creatinine
clearance < 40 mL/min. (2.3, 8.6)
DOSAGE FORMS AND STRENGTHS
For Injection: 500 mg lyophilized powder in a single dose vi