VALSTAR- valrubicin solution, concentrate

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

VALRUBICIN (UNII: 2C6NUM6878) (VALRUBICIN - UNII:2C6NUM6878)

Доступна с:

Endo Pharmaceuticals Solutions Inc.

ИНН (Международная Имя):

VALRUBICIN

состав:

VALRUBICIN 40 mg in 1 mL

Администрация маршрут:

INTRAVESICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is contraindicated in patients with: - Perforated bladder [ see Warnings and Precautions ( 5.2)] - Known hypersensitivity to anthracyclines or polyoxyl castor oil - Active urinary tract infection - Small bladder capacity and unable to tolerate a 75 mL instillation Risk Summary Based on findings in animal studies and its mechanism of action, VALSTAR can cause fetal harm when administered to a pregnant females [see Clinical Pharmacology ( 12.1and 12.3)] .  There are no available data in pregnant females to inform the drug-associated risk.  In animal reproduction studies, intravenous administration of valrubicin to pregnant rats during the period of organogenesis at a dose about 0.2 times the recommended human intr

Обзор продуктов:

VALSTAR is a sterile, clear red solution in polyoxyl castor oil/dehydrated alcohol, USP, containing 40 mg valrubicin per mL. VALSTAR is available in single-use, clear glass vials, individually packaged in the following sizes: NDC 67979-001-01                                         Carton of four 200 mg/5 mL single-use vials Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE.

Статус Авторизация:

New Drug Application

Характеристики продукта

VALSTAR- VALRUBICIN SOLUTION, CONCENTRATE
ENDO PHARMACEUTICALS SOLUTIONS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSTAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSTAR.
VALSTAR
(VALRUBICIN) SOLUTION, FOR INTRAVESICAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
VALSTAR is an anthracycline topoisomerase inhibitor indicated for
intravesical therapy of BCG-
refractory carcinoma _in situ_(CIS) of the urinary bladder in patients
for whom immediate cystectomy
would be associated with unacceptable morbidity or mortality. ( 1)
DOSAGE AND ADMINISTRATION
FOR INTRAVESICAL USE ONLY. ( 2.1)
VALSTAR is recommended at a dose of 800 mg administered intravesically
once a week for six weeks. (
2.1)
Delay administration at least two weeks after transurethral resection
and/or fulguration. ( 2.1)
Warm VALSTAR slowly to room temperature, but do not heat. ( 2.1)
Use caution when handling and preparing the solution of VALSTAR. (
2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/5 mL in single-use vials ( 3)
CONTRAINDICATIONS
Perforated bladder or compromised bladder mucosa ( 4, 5.2)
Hypersensitivity to anthracyclines or polyoxyl castor oil. ( 4)
Concurrent urinary tract infections. ( 4)
Patients with a small bladder capacity unable to tolerate a 75 mL
instillation. ( 4)
WARNINGS AND PRECAUTIONS
Delaying cystectomy can lead to development of metastatic bladder
cancer, which is lethal. ( 5.1)
Do not administer VALSTAR to patients with a perforated bladder or to
those in whom the integrity of
the bladder mucosa has been compromised. ( 5.2, 12.3)
Evaluate the status of the bladder before the intravesical
instillation of VALSTAR. ( 5.3)
Use with caution in patients with severe irritable bladder symptoms. (
5.4)
Embryo-Fetal Toxicity: VALSTAR can cause fetal harm. Advise females of
reproductive potential of the
potential risk to a fetus and to use effective contraception. ( 5.5,
8.1, 8.3)
ADVERSE REACTIONS
The most frequently reporte