Vinorelbine Injection USP is for intravenous administration. Each vial contains vinorelbine tartrate, USP equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic.
Vinorelbine tartrate, USP is a semi-synthetic vinca alkaloid with antitumor activity.
Vinorelbine Injection USP is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Vinorelbine Injection USP is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Vinorelbine Injection USP is indicated in combination with cisplatin.
Media Articles Related to Vinorelbine
Lung Cancer: Expanded Alimta Label
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has expanded the indication for the cancer drug pemetrexed injection to act as a maintenance therapy with cisplatin for nonsquamous non-small cell lung cancer.
Published Studies Related to Vinorelbine
Docetaxel vs. vinorelbine in elderly patients with advanced non--small-cell lung cancer: a hellenic oncology research group randomized phase III study. [2011.05]
BACKGROUND/PURPOSE: This study compared front-line treatment with docetaxel or vinorelbine in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC)... CONCLUSIONS: Docetaxel has an efficacy comparable to that of vinorelbine as first-line treatment in elderly patients with NSCLC and has an acceptable toxicity profile. The trial was closed prematurely because of low accrual, thus limiting the strength of the conclusions derived. Copyright (c) 2011. Published by Elsevier Inc.
A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study. [2011.04.12]
BACKGROUND: To evaluate activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naive relapsed breast cancer patients... CONCLUSIONS: Both anthracycline- containing regimens evaluated in the present study seem to be active and with a satisfactory tolerability in anthracycline-naive relapsed breast cancer patients.
Paclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG). [2011.04]
BACKGROUND: Paclitaxel (Taxol) and vinorelbine have shown synergism of cytotoxic effects in vitro and clinical activity in phase I and II studies. This combination was compared prospectively with the paclitaxel/gemcitabine regimen in non-operable non-small-cell lung cancer... CONCLUSION: Although response rate, PFS and survival were non-different in both groups, toxicity was significantly worse in group B and therefore further investigation of P-Vin is of no value. (c) The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer. [2011.03.29]
BACKGROUND: An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory... CONCLUSIONS: This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.
Second-line paclitaxel/carboplatin versus vinorelbine/carboplatin in patients who have advanced non-small-cell lung cancer pretreated with non-platinum-based chemotherapy: a multicenter randomized phase II study. [2011.03]
PURPOSE: This study evaluates the activity and toxicity of the paclitaxel/carboplatin (PC) doublet versus vinorelbine/carboplatin (VC) doublet as second-line treatment in patients who have advanced non-small-cell lung cancer (NSCLC)... CONCLUSIONS: Platinum-based doublets with either paclitaxel or vinorelbine in patients with advanced/metastatic NSCLC pretreated with front-line docetaxel/gemcitabine show comparable efficacy when used in the second-line setting. Copyright (c) 2011. Published by Elsevier Inc.
Clinical Trials Related to Vinorelbine
Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer [Completed]
The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine)
to be used with erlotinib in non-small cell lung cancer.
Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca [Recruiting]
This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel
combination given as an initial upfront treatment (first line) to all metastatic breast
cancer patients enrolled. Patients having a disease control following initial treatment,
will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial
will also compare the efficacy and safety of maintenance oral Vinorelbine versus
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer [Terminated]
RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving epirubicin together with vinorelbine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving epirubicin together with
vinorelbine works in treating patients with stage II, stage III, or stage IV breast cancer.
Study of Combination of Metronomic Oral Vinorelbine and Sorafenib in Patients With Advanced Non-small Cell Lung Cancer [Completed]
Targeting the blood supply of cancer, called anti-angiogenesis is a new but proven treatment
strategy. There are two ways of achieving this effect. The first way to specifically
target the molecular pathways that promote new blood vessel formation in cancer. An example
of such an agent is sorafenib, which is an oral agent and which is already in use worldwide
for the treatment of kidney and liver cancers. The second way is to target the cells lining
the blood vessels by using low dose of chemotherapy agents administered at frequent
intervals. This strategy is called metronomic chemotherapy. It is possible that combining
agents like sorafenib and metronomic chemotherapy may further enhance anti-cancer effects.
This study aims to determine the optimal way of combining oral vinorelbine in metronomic
doses and sorafenib. Oral vinorelbine is a chemotherapy agent that is already approved for
use in cancer treatment such as lung cancer. By combining both oral anti-cancer agents to
optimize their anti-angiogenic effects in this study, the potential benefit to the patients
can be tremendous and far-reaching. Special radiologic imagings and blood tests will be
incorporated into this study to help further the understanding of the anti-angiogenic
processes of both agents.
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer [Completed]
This study will evaluate the toxicity and secondary the efficacy of the combination
vinorelbine plus capecitabine in metastatic breast cancer patients
Reports of Suspected Vinorelbine Side Effects
Hepatic Failure (22),
Neutropenic Sepsis (21),
Febrile Neutropenia (20),
Interstitial Lung Disease (15),
Constipation (11), more >>