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Navelbine (Vinorelbine Tartrate) - Summary

 
 



WARNING

NAVELBINE (vinorelbine tartrate) Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled "WARNING - FOR IV USE ONLY. FATAL if given intrathecally."

Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be >/=1,000 cells/mm3 prior to the administration of NAVELBINE. The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.

Caution - It is extremely important that the intravenous needle or catheter be properly positioned before NAVELBINE is injected. Administration of NAVELBINE may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).

 

NAVELBINE SUMMARY

NAVELBINE (vinorelbine tartrate) Injection is for intravenous administration. Each vial contains vinorelbine tartrate 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.

NAVELBINE 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, NAVELBINE is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE is indicated in combination with cisplatin.


See all Navelbine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Navelbine (Vinorelbine)

Promising results shown with targeted approaches in subsets of non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2014.09.30]
The BRAF inhibitor dabrafenib has significant anti-tumour activity in patients with advanced BRAF V600E mutant non-small cell lung cancer whose disease has progressed after chemotherapy, according...

AZD9291 shows durable clinical response in patients with advanced EGFR mutation positive non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2014.09.30]
Updated data from the ongoing AURA study of AZD9291 shows encouraging, although still immature, median progression free survival of 9.6 months (95% CI 8.

Some stage IV lung cancer patients achieve long-term survival after aggressive treatments
Source: Radiology / Nuclear Medicine News From Medical News Today [2014.09.19]
A large, international analysis of patients with stage IV non-small cell lung cancer (NSCLC) indicates that a patient's overall survival (OS) rate can be related to factors including the timing of...

SBRT Transforms Lives of Many With NSCLC (CME/CE)
Source: MedPage Today Radiology [2014.09.19]
(MedPage Today) -- A cohort of patients with inoperable non-small cell lung cancer had a 5-year survival of 40%.

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.

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Published Studies Related to Navelbine (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.

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Clinical Trials Related to Navelbine (Vinorelbine)

Vinorelbine/Gemcitabine Verses Vinorelbine/Carboplatin in Advanced Non-Small Cell Lung Cancer [Recruiting]

Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer [Active, not recruiting]
The purpose of this study is to find the highest dose of capecitabine and oral navelbine that can be given without causing severe side effects, and to determine the safety, tolerability, and effects (good and bad) of capecitabine given with oral navelbine to patients with advanced breast cancer.

Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer [Recruiting]
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.

BIBW 2992 and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2 [Recruiting]
To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i. v. and oral Safety and anti-tumour efficacy data and determination of pharmacokinetic characteristics of BIBW 2992, vinorelbine i. v. and vinorelbine oral.

Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer [Completed]
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.

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Reports of Suspected Navelbine (Vinorelbine) Side Effects

Febrile Neutropenia (10)Confusional State (8)Tachycardia (8)Tongue Neoplasm Malignant Stage Unspecified (8)Diarrhoea (7)Neoplasm Progression (6)Pyrexia (6)Pleural Effusion (6)Cardiotoxicity (6)Neutropenia (6)more >>


Page last updated: 2014-09-30

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