Vinorelbine (Page 5 of 5)

14.2 Single Agent

The safety and efficacy of vinorelbine as a single agent was evaluated in one randomized multicenter trial. Study 3 was a randomized, open-label clinical trial of vinorelbine or fluorouracil (FU) plus leucovorin (LV) in patients with Stage IV NSCLC who had not received prior chemotherapy A total of 211 patients were randomized 2:1 to receive vinorelbine 30 mg/m2 weekly of an 8-week cycle (N=143) or FU 425 mg/m2 bolus intravenously plus LV 20 mg/m2 bolus intravenously daily for 5 days of a 4-weeks cycle (N=68).

Patient demographics and disease characteristics were in general similar between arms. In the overall population, the median age was 61 years (range 32 to 83), 74% were male, 88% were White, 46% had adenocarcinoma histology. Fifty percent of the patients had Karnofsky performance status ≥ 90 in the vinorelbine arm compared to 38% in the FU/LV arm.

The primary efficacy outcome of the study was overall survival. The median survival time was 30 weeks versus 22 weeks for patients receiving vinorelbine versus FU/LV, respectively (p=0.06). Partial objective responses were observed in 11.1% (95% CI=6.2%, 17.9%) and 3.5% (95% CI=0.4%, 11.9%) of patients who received vinorelbine and FU/LV, respectively.

15 REFERENCES

  1. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

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:

NDC Vinorelbine Injection, USP Package Factor
45963-607-55 10 mg/mL Single-Dose Vial 1 vial per carton
45963-607-56 50 mg/5 mL (10 mg/mL) Single-Dose Vial 1 vial per carton

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

17 PATIENT COUNSELING INFORMATION

Myelosuppression

Advise patients to contact a healthcare provider for new onset fever, or symptoms of infection [see Warnings and Precautions (5.1)].

Constipation and Bowel Obstruction

Advise patients to follow a diet rich in fibers, drink fluids to stay well hydrated and use stool softeners to avoid constipation. Contact a health care provider for severe constipation, new onset abdominal pain, nausea and vomiting [see Warnings and Precautions (5.3)].

Neurologic Toxicity

Advise patients to contact a health care provider for new onset or worsening of numbness, tingling, decrease sensation or muscle weakness [see Warnings and Precautions (5.5)].

Pulmonary Toxicity

Advise patients to contact a healthcare provider for new onset or worsening of shortness of breath, cough, wheezing or other new pulmonary symptoms [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

  • Advise pregnant women of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].
  • Advise females of reproductive potential to use effective contraception during treatment with vinorelbine and for 6 months after the final dose [see Use in Specific Populations (8.3)].
  • Advise males with female partners of reproductive potential to use effective contraception during treatment with vinorelbine and for 3 months after the final dose [see Use in Specific Population (8.3) and Nonclinical Toxicology (13.1)].

Lactation

Advise women not to breastfeed during treatment with vinorelbine and for 9 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males of reproductive potential that vinorelbine may impair fertility [see Use in Specific Populations (8.3)].

Manufactured In Romania By:
Sindan Pharma SRL
Bucharest 1, Romania

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. D 5/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 45963-607-55

Vinorelbine Injection, USP

10 mg/mL

For Intravenous Use Only

Must Be Diluted Before Use

Discard Unused Portion

CAUTION: Cytotoxic Agent

Rx only

1 mL

Single-Dose Vial

new
(click image for full-size original)
VINORELBINE
vinorelbine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-607
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VINORELBINE TARTRATE (VINORELBINE) VINORELBINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-607-55 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (45963-607-55)
2 NDC:45963-607-56 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (45963-607-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078011 03/01/2015
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 05/2022 Actavis Pharma, Inc.

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