País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)
Teva Parenteral Medicines, Inc.
VINORELBINE TARTRATE
VINORELBINE 10 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
VINORELBINE- VINORELBINE INJECTION, SOLUTION, CONCENTRATE TEVA PARENTERAL MEDICINES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VINORELBINE INJECTION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VINORELBINE INJECTION USP. VINORELBINE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1994 WARNING: MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS 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 TEVA USA, PHARMACOVIGILANCE AT 1-866-832-8537 OR DRUG.SAFETY@TEVAPHARM.COM; 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). Vinorelbine injection USP is a vinca alkaloid indicated: 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 use vials of 10 mg/1 mL and 50 mg/5 mL (3) None Hepatic toxicity: monitor liver function during treatment (5.2) Severe constipation and bowel obstruction including necrosis and perforation can occur. Institute a prophylactic bow Leer el documento completo