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 supplied as follows:

Vinorelbine Injection, USP
NDC (10 mg per mL) Package Factor
25021-204-01 10 mg per mL Single-Dose Vial 1 vial per carton
25021-204-05 50 mg per 5 mL Single-Dose Vial 1 vial per carton

Vinorelbine Injection, USP is a clear, colorless to pale yellow aqueous solution.

Storage Conditions
Store refrigerated between 2° and 8°C (36° and 46°F).

Do not freeze.
Protect from light. Retain in carton until time of use.
Discard unused portion.

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

Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.

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 Injection 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 Injection and for 3 months after the final dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].

Lactation

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

Infertility

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

SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in China©2020 Sagent Pharmaceuticals, Inc.

Revised: April 2020

SAGENT Pharmaceuticals®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-204-01

VINORELBINE INJECTION, USP

10 mg per mL

Rx only

1 mL Single-Dose Vial

Must Be Diluted

For Intravenous Use Only

Caution: Cytotoxic Agent

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)
VINORELBINE vinorelbine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-204
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:25021-204-01 1 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (25021-204-01)
2 NDC:25021-204-05 1 VIAL in 1 CARTON contains a VIAL
2 5 mL in 1 VIAL This package is contained within the CARTON (25021-204-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091106 09/15/2014
Labeler — Sagent Pharmaceuticals (796852890)

Revised: 04/2020 Sagent Pharmaceuticals

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