देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
VINORELBINE TARTRATE (UNII: 253GQW851Q) (VINORELBINE - UNII:Q6C979R91Y)
Ingenus Pharmaceuticals, LLC
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 injection 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
Vinorelbine injection, USP is a clear, colorless to pale yellow aqueous solution available in single-dose vial, individually packaged in a carton as: Store the vials at 2° to 8°C (36° to 46°F). Protect from light. DO NOT FREEZE. Retain in carton until use. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F) [see Dosage and Administration (2.3)] . Vinorelbine injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Abbreviated New Drug Application
VINORELBINE- VINORELBINE INJECTION INGENUS PHARMACEUTICALS, LLC ---------- 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 INJECTION 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/1 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 injection 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 n पूरा दस्तावेज़ पढ़ें