Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)
Actavis Pharma, Inc.
VINORELBINE
VINORELBINE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Vinorelbine injection is indicated: - In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) - As a single agent for the treatment of patients with metastatic NSCLC None Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], Vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 1
Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in water for injection, USP containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-dose, clear glass vials with elastomeric stoppers and white (10 mg/mL) and lime green (50 mg/5 mL) caps, individually packaged in a carton in the following vial sizes: Storage Conditions Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Protect from light. DO NOT FREEZE. The vial stopper is not made with natural rubber latex. Sterile, Nonpyrogenic, Preservative-free. Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Abbreviated New Drug Application
VINORELBINE- VINORELBINE INJECTION, SOLUTION ACTAVIS PHARMA, 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, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1994 WARNING: MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK, AND DEATH CAN OCCUR (5.1). DECREASE THE DOSE OR WITHHOLD VINORELBINE IN ACCORD WITH RECOMMENDED DOSE MODIFICATIONS (2.2). INDICATIONS AND USAGE Vinorelbine injection 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) DOSAGE AND ADMINISTRATION In combination with cisplatin: 25 to 30 mg/m as an intravenous injection or infusion once weekly (2.1) Single agent: 30 mg/m as intravenously once a week (2.1) Adjust dose in patients with decreased neutrophil counts or elevated serum total bilirubin (2.2) DOSAGE FORMS AND STRENGTHS Injection: 10 mg/mL and 50 mg/5 mL in single-dose vial (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment (5.2) Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus. (5.3) Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop vinorelbine and institute recommended management procedures (5.4) Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy (5.5) Pulmonary toxicity a Preberite celoten dokument