Product image of Navelbine (Vinorelbine Tartrate) supplied by GNH India

Navelbine

Active Ingredient:
Vinorelbine Tartrate
Origin:
EU

Navelbine (Vinorelbine Tartrate)

Vinorelbine tartrate, the active ingredient in Navelbine, is a Vinca alkaloid presented as an oral capsule for oral use. It is employed in the treatment of certain advanced solid tumours, primarily non‑small cell lung cancer and metastatic breast cancer, in adult patients.

GNH India supplies Navelbine as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution. Its portfolio supports clinical oncology programs across Europe, Asia and the Americas.

Manufacturer / TM Owner

Pierre Fabre Medicament

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Indications & Clinical Uses

Navelbine (vinorelbine tartrate) is used in oncology to target rapidly dividing cancer cells in specific solid tumours.

  • Non‑small cell lung cancer: administered as part of first‑line or second‑line therapy to inhibit tumor progression.
  • Metastatic breast cancer: used to reduce disease spread and improve survival outcomes.
  • Combination regimens for NSCLC: incorporated with platinum‑based agents to enhance overall response rates.

How It Works

  • Vinorelbine tartrate binds to tubulin at the vinca binding site, preventing microtubule polymerisation. This disruption halts mitotic spindle formation, leading to mitotic arrest and apoptosis of rapidly proliferating cancer cells. The drug’s activity is independent of hormone receptors and is primarily cytotoxic to dividing tumour cells.

Side Effects

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: gastrointestinal upset often managed with anti‑emetics.
  • Constipation: decreased bowel motility requiring dietary measures.
  • Fatigue: persistent tiredness affecting daily activities.
  • Alopecia: hair thinning or loss during treatment.
  • Peripheral neuropathy: tingling or numbness in extremities.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical care.
  • Severe allergic reactions: rash, swelling, or anaphylaxis.
  • Pulmonary toxicity: shortness of breath or cough indicating lung involvement.
  • Cardiac arrhythmias: irregular heart rhythm observed in susceptible patients.
  • Hepatic dysfunction: elevated liver enzymes indicating liver stress.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient suitability and monitor for adverse events.

  • Blood count monitoring: perform complete blood counts regularly to detect neutropenia.
  • Hepatic function assessment: check liver enzymes prior to and during treatment.
  • Cardiac evaluation: consider ECG in patients with known heart disease.
  • Infection risk: avoid use in patients with active severe infections.
  • Contraception: advise effective contraception during treatment and for a defined period after.
  • Store at below 25°C: keep capsules in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Vinorelbine may interact with other medicines that affect its metabolism or increase myelosuppression.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise vinorelbine plasma levels and toxicity.
  • Concurrent use with other myelosuppressive chemotherapy agents: can markedly increase risk of severe neutropenia.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effectiveness.
  • Anticoagulants (e.g., warfarin): monitor coagulation parameters as vinorelbine can alter bleeding risk.
  • Drugs causing QT prolongation: observe cardiac rhythm when combined with agents that affect cardiac repolarisation.

Frequently Asked Questions

Navelbine (vinorelbine tartrate) is indicated for the treatment of adult patients with non‑small cell lung cancer and metastatic breast cancer. It is used either as a single agent or in combination with other chemotherapy drugs to slow disease progression and improve survival outcomes.

Vinorelbine interferes with microtubule assembly by binding to tubulin, which prevents the formation of the mitotic spindle required for cell division. This blockade leads to mitotic arrest and triggers apoptosis in rapidly dividing cancer cells, reducing tumor growth.

The prescribed dose of Navelbine is determined by the treating physician based on the patient’s cancer type, stage, overall health, and prior therapies. Dosing regimens are individualized and may involve specific days of administration within a treatment cycle.

Safety of vinorelbine during pregnancy and lactation has not been established. It is generally contraindicated in pregnant or nursing women because of potential fetal harm or drug transfer through breast milk. Patients should discuss contraception and breastfeeding plans with their healthcare provider.

To order Navelbine, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The sales team then replies with pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Vinorelbine belongs to the Vinca alkaloid class, offering a distinct mechanism from taxanes such as paclitaxel or docetaxel. Compared with taxanes, vinorelbine is administered orally, which can improve convenience, but it may have a higher incidence of neutropenia. Choice of therapy depends on tumour characteristics, prior treatment history and patient tolerance.

Navelbine oral capsules should be stored at temperatures below 25 °C, in the original container, protected from moisture and direct sunlight. Do not refrigerate or freeze the product. Keep out of reach of children and handle according to standard pharmaceutical safety procedures.

Navelbine is taken orally as a capsule with a full glass of water, usually on an empty stomach or as directed by the prescriber. The capsule should be swallowed whole and not crushed or chewed. Administration timing and any required fasting periods are specified by the treating physician.

The most critical adverse events include severe neutropenia or febrile neutropenia, which can lead to life‑threatening infections, and rare but serious allergic reactions such as anaphylaxis. Patients should promptly report fever, chills, persistent cough, shortness of breath, or any signs of severe hypersensitivity to their healthcare provider.

Navelbine is contraindicated in patients with known hypersensitivity to vinorelbine or other Vinca alkaloids, those with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment. It should also be avoided in pregnant or nursing women unless the benefits outweigh the risks, as determined by a qualified physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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