País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)
Hospira, Inc.
VINORELBINE TARTRATE
VINORELBINE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
VINORELBINE- VINORELBINE INJECTION, SOLUTION HOSPIRA, INC. ---------- 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._ • • INDICATIONS AND USAGE Vinorelbine Injection, USP, is a vinca alkaloid indicated: • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • • • • • • 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 • 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 Leia o documento completo