VINORELBINE- vinorelbine injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)

Sẵn có từ:

Hospira, Inc.

INN (Tên quốc tế):

VINORELBINE TARTRATE

Thành phần:

VINORELBINE 10 mg in 1 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Vinorelbine Injection, USP is indicated: None Pregnancy Category D Risk Summary Vinorelbine can cause fetal harm when administered to a pregnant woman. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Animal Data In a mouse embryofetal development study, administration of a single dose of vinorelbine at a dose level of 9 mg/m2 or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic. Vinorelbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m2 (approximately 0.18 times the recommended human dose based on body surface area) or greater. At doses t

Tóm tắt sản phẩm:

Vinorelbine Injection, USP is a clear, colorless to pale yellow aqueous solution available in single-dose, clear glass vials with elastomeric stoppers and green caps, individually packaged in a carton in the following vial sizes: 10 mg/mL Single-Dose Vial, Carton of 1 (NDC 61703-341-06). 50 mg/5 mL Single-Dose Vial, Carton of 1 (NDC 61703-341-09). Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

VINORELBINE- VINORELBINE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VINORELBINE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VINORELBINE
INJECTION.
VINORELBINE INJECTION, USP, INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1994
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Vinorelbine Injection, USP, is a vinca alkaloid indicated:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 20%) are neutropenia,
anemia, liver enzyme elevation, nausea, vomiting,
asthenia, constipation, injection site reaction, and peripheral
neuropathy. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HOSPIRA, INC. AT
1-800-441-4100, OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
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SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
AND DEATH MAY OCCUR (5.1).
DECREASE THE DOSE OR WITHHOLD VINORELBINE IN ACCORD WITH RECOMMENDED
DOSE MODIFICATIONS (2.2).
In combination with cisplatin for first-line treatment of patients
with locally advanced or metastatic non-small cell lung
cancer (NSCLC). (1)
As a single agent for first-line treatment of patients with metastatic
NSCLC. (1)
In combination with cisplatin: 25 to 30 mg/m as a single intravenous
injection weekly. (2.1)
2
Single agent: 30 mg/m as a single intravenous injection weekly. (2.1)
2
Adjust the dose in patients with decreased neutrophil counts or
elevated serum total bilirubin. (2.2)
Injection: single-dose vials of 10 mg/mL and 50 mg/5 mL (3)
Hepatic toxicity: monitor liver function during treatment. (5.2)
Severe constipation and bowel obstruction including necrosis and
perforation can occur. Institute a prophylactic
bowel regimen to mitigate potential constipation. Moni