Navelbine Vinorelbine Application Scope

Navelbine is indicated for the treatment of non-small cell lung cancer and metastatic breast cancer.

Navelbine Characteristics

Ingredients: Vinorelbine tartrate
Properties: A clear, colourless or slightly yellow liquid, belonging to the class of antineoplastic drugs known as vinca alkaloids.
Packaging Specification: 1ml: 10mg / 5ml: 50mg
Storage: Store in a refrigerator at 2°C to 8°C, protected from light. Once opened or diluted, it may be kept in a sealed container at room temperature for up to 24 hours.
Expiry Date: 36 months
Executive Standard: JX20030138
Approval Number: H20080497，H20080498
Date of Revision: See the latest approved package insert
Manufacturer: Pierre Fabre Pharmaceuticals, France

Guidelines for the Use of Navelbine Vinorelbine

Dosage and Administration:
- Recommended Dose:
  - The standard single-agent dose is 25–30 mg/m², administered weekly. Dosing occurs on days 1 and 8, with a 21-day cycle. Two to three cycles constitute one course of treatment.
  - When combined with chemotherapy, the dosage and timing are determined by the selected regimen. The standard dose (25–30 mg/m²) is typically maintained, but it is recommended to reduce the frequency of administration according to the regimen, such as on Days 1 and 8 of every 3-week cycle.
- Administration: This product is for intravenous use only. The drug must be diluted with physiological saline solution (e.g., 125ml) and administered intravenously over a short period (15-20 minutes). Following administration, the vein must be flushed with a large volume of physiological saline solution.
- Missed Dose: Please consult your prescribing doctor.
Adverse Reactions:
- Common Adverse Reactions: Certain adverse reactions are relatively common, primarily including bone marrow suppression (particularly neutropenia, which is its most significant dose-limiting toxicity), nausea and vomiting, constipation, peripheral neurotoxicity such as limb numbness, and local reactions like injection site pain or phlebitis. Additionally, hair loss and fatigue frequently occur.
- Serious Adverse Reactions: Certain serious but infrequent adverse reactions warrant heightened vigilance, including life-threatening severe infections arising from profound bone marrow suppression, acute respiratory distress or bronchospasm occurring shortly after administration, severe neurotoxicity potentially leading to intestinal paralysis, and severe allergic reactions including anaphylactic shock.
Contraindications:
- Known hypersensitivity to vinorelbine, other vinca alkaloids, or any component of this product.
- Neutrophil count <1500/mm³, or current or recent (within 2 weeks) severe infection.
- Platelet count <100,000/mm³.
- Must not be administered concomitantly with yellow fever vaccine.
- Lactation (see section on use in pregnant and lactating women).
Precautions:
- Blood monitoring: A complete blood count (haemoglobin, white blood cell and granulocyte counts) must be performed prior to each administration. Treatment should be suspended when granulocytopenia occurs (e.g. <2000/mm³).
- Hepatic and renal function: Dose reduction is required in patients with hepatic impairment; exercise caution in those with renal impairment.
- Special populations: Use with caution in patients with ischaemic heart disease.

Vinorelbine Interactions

Dilution contraindications: Do not dilute with alkaline solutions to avoid precipitation.
Contraindicated combinations: Phenytoin may reduce its absorption, potentially causing seizures; yellow fever vaccine may induce fatal systemic vaccine disease.
Contraindicated/Caution required: Itraconazole may increase neurotoxicity risk; mitomycin C may increase pulmonary toxicity risk; when combined with other cytotoxic agents (e.g., cisplatin), toxicity such as bone marrow suppression may be heightened.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.