VALRUBICIN INTRAVESICAL SOLUTION solution, concentrate

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Hikma Pharmaceuticals USA Inc.

Ievadīšanas:

INTRAVESICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Valrubicin intravesical solution 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. Valrubicin intravesical solution is contraindicated in patients with: Risk Summary Based on findings in animal studies and its mechanism of action, valrubicin intravesical solution can cause fetal harm when administered to a pregnant females [see Clinical Pharmacology (12.1 and 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 intravesical dose caused embryo-fetal malformations and increased resorptions [see Data] . Advise females who are or might become pregnant of the potential risk to a fetus. In the U.S. general p

Produktu pārskats:

Valrubicin Intravesical Solution, USP is a sterile, clear red solution in polyoxyl castor oil/dehydrated alcohol, USP, containing 40 mg valrubicin per mL. Valrubicin Intravesical Solution, USP is available in single-use, clear glass vials, individually packaged in the following sizes: Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE. The container closure is not made with natural rubber latex.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

VALRUBICIN INTRAVESICAL SOLUTION- VALRUBICIN INTRAVESICAL
SOLUTION SOLUTION, CONCENTRATE
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALRUBICIN
INTRAVESICAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VALRUBICIN INTRAVESICAL SOLUTION.
VALRUBICIN INTRAVESICAL SOLUTION, FOR INTRAVESICAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequently reported adverse reactions (>5%) after
administration of valrubicin intravesical
solution are urinary frequency, dysuria, urinary urgency, bladder
spasm, hematuria, bladder pain, urinary
incontinence, cystitis, urinary tract infection, nocturia, local
burning symptoms, abdominal pain, and
nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA AT
[e-mail] OR CALL 1-877-845-0689 OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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Valrubicin intravesical solution 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)
FOR INTRAVESICAL USE ONLY. (2.1)
Valrubicin intravesical solution 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 valrubicin intravesical solution slowly to room temperature, but
do not heat. (2.1)
Use caution when handling and preparing the solution of valrubicin
intravesical solution. (2.2)
Injection: 200 mg/5 mL in single-use vials (3)
Perforated bladder or compromised bladder mucosa (4, 5.2)
Hypersensitivity to anthracyclines or polyoxyl castor