FDA-filed SPL labeling · retrieved through openFDA

Vinorelbine Injection

Vinorelbine Injection is a chemotherapy medicine used to treat locally advanced or metastatic non-small cell lung cancer (NSCLC), given intravenously either alone or with cisplatin.

Brand name Navelbine
Drug class Vinca Alkaloids
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 16, 2024
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 1994
FDA-listed product records 4
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Vinorelbine Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Vinorelbine Injection is a proven intravenous chemotherapy for non-small cell lung cancer, used alone or with cisplatin. Its most critical risk is severely lowered blood cell counts, which requires close monitoring and possible dose adjustments throughout treatment. Always keep all scheduled blood tests and appointments, and report any fever, infection signs, or new symptoms to your oncology team right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Vinorelbine Injection can severely suppress the bone marrow's ability to make blood cells — a condition called myelosuppression. This can lead to dangerously low white blood cell counts, serious infections, septic shock (a life-threatening response to infection), hospitalization, and death. Your care team will monitor your blood counts regularly and may lower your dose or pause treatment if your counts drop too low. Tell your doctor or nurse immediately if you develop fever, chills, or any signs of infection during treatment.

Read the full warning on DailyMed →

📖 Vinorelbine Injection: Patient Information Guide

A plain-language walkthrough of Vinorelbine Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Vinorelbine Injection is a chemotherapy agent approved to treat non-small cell lung cancer (NSCLC). All uses are by intravenous infusion in a clinical setting.

  • Vinorelbine Injection is indicated in combination with cisplatin for the first-line treatment of locally advanced or metastatic NSCLC
  • Vinorelbine Injection is indicated as a single agent for the treatment of metastatic NSCLC
⚙️How it works

Vinorelbine is a vinca alkaloid — a type of chemotherapy that targets the internal skeleton cancer cells rely on to divide. Specifically, it blocks the assembly of structures called mitotic microtubules, which are essential for pulling chromosomes apart during cell division. This traps cancer cells at the metaphase stage of division, effectively stopping them from reproducing.

At the doses used clinically, vinorelbine shows a preference for acting on dividing (mitotic) cells rather than nerve-cell microtubules, though nerve-related side effects can still occur at higher concentrations. It may also interfere with other cellular processes including amino acid metabolism, cellular respiration, and nucleic acid production.

💊How it's taken

Vinorelbine Injection is given intravenously — always by a healthcare professional in a clinic or hospital setting, never at home. It is administered once a week as a short infusion (over 6 to 10 minutes). The schedule varies depending on whether it is used alone or in combination with cisplatin, and your oncology team will set your specific plan.

  • When used alone, Vinorelbine Injection is given once weekly
  • When used with cisplatin, the schedule depends on the cisplatin regimen — your care team will explain your specific cycle
  • Dose may be reduced or held based on blood count results or liver function before each treatment

Follow your oncologist's instructions exactly — do not adjust the schedule on your own.

🤒Side effects — in detail

The most common side effects of Vinorelbine Injection include:

  • Neutropenia and leukopenia (low white blood cell counts, raising infection risk)
  • Anemia (low red blood cell count, causing fatigue)
  • Nausea and vomiting
  • Constipation
  • Fatigue and weakness (asthenia)
  • Injection site pain or reaction
  • Peripheral neuropathy (numbness, tingling, or weakness in the hands and feet)
  • Elevated liver enzymes (AST)

Serious reactions that need prompt medical attention include high fever or signs of infection (which could indicate dangerously low blood counts), severe constipation or inability to pass stool, worsening nerve symptoms, new or worsening shortness of breath, and redness or swelling at the IV site.

⚠️Warnings & precautions
  • Myelosuppression (bone marrow suppression): The biggest risk — severely low blood cell counts can lead to life-threatening infection, septic shock, and death. Blood counts must be checked before every dose and the dose adjusted accordingly.
  • Severe constipation and bowel obstruction: Vinorelbine can cause bowel paralysis, obstruction, tissue death, and perforation. A preventive bowel routine should be started with treatment.
  • Extravasation (IV leakage): If the drug leaks outside the vein, it can cause severe tissue damage and necrosis. The infusion must be stopped immediately if this is suspected.
  • Neurologic toxicity: Serious nerve damage (sensory and motor neuropathy) can occur. Treatment is stopped for moderate or severe neuropathy.
  • Pulmonary toxicity: Serious lung reactions including interstitial pneumonitis (lung inflammation) and acute respiratory distress can occur. Treatment is paused or permanently stopped if these develop.
  • Liver toxicity: Liver function must be monitored; dose reductions are required for elevated bilirubin levels.
  • Embryo-fetal toxicity: Vinorelbine can harm an unborn baby. Effective contraception is required during and after treatment.
🔀What it interacts with

Vinorelbine is broken down by a liver enzyme called CYP3A. Drugs that block this enzyme can raise vinorelbine levels in the body, increasing the risk and severity of side effects.

  • CYP3A4 inhibitors (such as certain antifungal medicines, some antibiotics like clarithromycin, and some HIV medications): Can cause vinorelbine side effects to appear earlier or be more intense — tell your oncologist about every medicine you take before starting treatment

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Pregnancy: Vinorelbine can cause serious harm to a fetus — inform your doctor if you are pregnant or could become pregnant
  • Breastfeeding: Do not breastfeed during treatment or for 9 days after the last dose
  • Women of childbearing potential: Use effective contraception during treatment and for 6 months after the final dose; pregnancy should be ruled out before starting
  • Men with partners who could become pregnant: Use contraception during treatment and for 3 months after the final dose; vinorelbine may damage sperm and may impair male fertility
  • Liver impairment: The liver plays a major role in processing vinorelbine — dose reductions are required if bilirubin levels are elevated; use with caution in liver disease
  • Children: Safety and effectiveness in pediatric patients have not been established
  • Older adults (65+): No significant differences in safety, effectiveness, or drug clearance were seen compared to younger patients in clinical studies
  • Other medications: Tell your care team about all prescription, over-the-counter, and herbal products — especially anything that affects liver enzymes
🚑If you take too much

There is no known antidote for a vinorelbine overdose. Overdoses have been reported and can cause severe bone marrow failure, paralytic ileus (bowel paralysis), mouth sores, esophagus inflammation, nerve paralysis (paresis), serious infections, and death. If an overdose occurs, treatment is supportive — including blood transfusions, growth factors to stimulate blood cell production, and antibiotics as needed.

📡Pharmacodynamics — effects in the body

Vinorelbine works by preventing cancer cells from completing cell division. It blocks the formation of mitotic microtubules — the internal structures cells use to separate chromosomes — trapping cells at metaphase and stopping them from dividing further. At the concentrations used clinically, it shows some selectivity for these dividing-cell microtubules over the microtubules found in nerve fibers, though nerve toxicity can still occur.

🔬Pharmacokinetics — how your body processes it

After intravenous infusion, vinorelbine distributes widely throughout the body and binds extensively to blood cells and plasma proteins (roughly 80–91%). It is broken down mainly by the liver using the CYP3A enzyme system, with its primary active breakdown product being deacetylvinorelbine. The drug is eliminated mostly through the feces, with a smaller portion in the urine, and has a long half-life averaging roughly 28 to 44 hours — meaning it stays in the body for a day or more after each dose. Age does not meaningfully affect how the body handles vinorelbine, and concurrent cisplatin does not alter its pharmacokinetics.

📦How to store it

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Protect from light.

📄 Written from Vinorelbine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

138

Supplements & herbs that interact with Vinorelbine Injection

138 supplements and herbal products have documented interactions with Vinorelbine Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
Every supplement checked against Vinorelbine Injection — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Vinorelbine Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Vinorelbine Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is vinorelbine being used to treat?
Vinorelbine Injection is a chemotherapy used to treat non-small cell lung cancer (NSCLC) that has spread — either within the chest or to other parts of the body. Depending on your situation, your oncologist may prescribe it on its own or together with another chemotherapy drug called cisplatin. Both approaches are established options for this type of lung cancer.
How will I receive this medication — do I take it at home?
No, vinorelbine is always given by a nurse or other trained professional through an IV in a clinic, infusion center, or hospital. You can't take it at home. Each infusion takes about 6 to 10 minutes, and it's typically scheduled once a week. Your care team will set up your specific schedule depending on whether you're also receiving cisplatin.
What side effects should I expect, and which ones mean I should call someone right away?
Very common side effects include nausea, fatigue, constipation, and numbness or tingling in your hands or feet. Low blood counts are also very common, and that's the biggest concern — if your white blood cell count drops too low, you're at risk for serious infection. Call your care team immediately if you develop a fever, chills, or feel suddenly unwell, as this can be a medical emergency. Also call right away if you have severe constipation, worsening numbness or weakness, or any new shortness of breath.
I've heard about something called 'extravasation' — what is that and should I worry?
Extravasation means the IV medication leaks out of the vein into the surrounding tissue. With vinorelbine, this is a serious problem because the drug can cause significant tissue damage if it escapes the vein. Your nursing team will make sure the IV is properly placed before starting your infusion. If you feel burning, stinging, or see swelling at the IV site during your infusion, tell the nurse immediately so they can stop it and treat the area.
Can I take my regular medications while on vinorelbine?
It depends on what you're taking. Some medications — including certain antifungals, antibiotics, and HIV drugs — can interact with vinorelbine by slowing how your liver breaks it down, which can make side effects worse or hit sooner. Give your oncologist and pharmacist a complete list of everything you take, including vitamins and herbal supplements, before you start treatment.
Is vinorelbine safe if I'm pregnant or planning to become pregnant?
Vinorelbine can seriously harm a developing baby, so it's very important to avoid pregnancy during treatment. Women should use effective birth control during treatment and for 6 months after the last dose. Men should use contraception during treatment and for 3 months after. If you're breastfeeding, you'll need to stop — the drug should be avoided during breastfeeding and for 9 days after the final dose. Talk to your care team about the best options for your situation.
Is Vinorelbine Injection available over the counter?
Vinorelbine Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Vinorelbine Injection first available?
Vinorelbine Injection has been available in the United States since at least 1994, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Vinorelbine Injection?
Vinorelbine Injection is supplied by 2 manufacturers listed in the FDA NDC Directory, including Actavis Pharma, Inc., Sagent Pharmaceuticals.

💬 Answers drafted from Vinorelbine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Vinorelbine Injection comes

Vinorelbine Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
How this form is used
What it may be used for
  • Vinorelbine Injection is used in combination with cisplatin as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • Vinorelbine Injection is used as a single agent for the treatment of metastatic NSCLC
Important instructions
  • Vinorelbine Injection is given intravenously — it must only be administered through a vein by a trained healthcare professional
  • Vinorelbine Injection is infused over 6 to 10 minutes, typically once a week, into the side port of a free-flowing IV line, followed by a flush
  • Vinorelbine Injection must be diluted before use and visually checked for particles — it should not be given if particles are visible
  • If Vinorelbine Injection leaks outside the vein (extravasation), administration must be stopped immediately and the care team must manage the site according to clinical protocol
Available strengths 1 strength
4 FDA-listed product records

📊 Vinorelbine Injection across the U.S. market

How Vinorelbine Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
2
Manufacturers
1
Brand names
4
FDA-listed product records
1994
First marketed
Actavis Pharma, Inc.50%
Sagent Pharmaceuticals50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Vinorelbine Injection is used

A general measure of how commonly Vinorelbine Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Vinorelbine Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

384
Medicaid prescriptions filled (Q1–Q4 2025)
$39,466 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Vinorelbine Injection prescribed? Of the 1,596 medications we measure, Vinorelbine Injection ranks #1,386 by Medicaid prescriptions — more than 13% of them.

Where Vinorelbine Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Vinorelbine Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mL / 10 mg/mL injection is the most-dispensed Vinorelbine Injection product — about 59% of these Medicaid prescriptions.

5 ML vinorelbine 10 MG/ML Injection Most dispensed

227 Medicaid prescriptions (Q1–Q4 2025) 59% of Vinorelbine Injection prescriptions shown $19,325 gross reimbursement (before rebates) ≈ $85 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1729422

1 ML vinorelbine 10 MG/ML Injection

157 Medicaid prescriptions (Q1–Q4 2025) 41% of Vinorelbine Injection prescriptions shown $20,141 gross reimbursement (before rebates) ≈ $128 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1729418

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vinorelbine Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 7 listed Vinorelbine Injection NDCs with Medicaid activity.

🔍 Compare Vinorelbine Injection products

A representative set of FDA-listed product records for Vinorelbine Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
10 mg/mL Intravenous Actavis Pharma, Inc. × 2 listings ANDA View NDC →
10 mg/mL Intravenous Sagent Pharmaceuticals × 2 listings ANDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Vinorelbine Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Vinorelbine Injection RxCUI 39541 1 dose form · 2 strengths

Look up RxCUI 39541 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Navelbine

🏭 Manufacturers & labelers

Actavis Pharma, Inc. 2 Sagent Pharmaceuticals 2

RxNorm drug class

Vinorelbine Injection belongs to the Vinca Alkaloid class.

Pharmacologic class Vinca Alkaloid
Drug family (ATC) Vinca alkaloids and analogues

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 16, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Vinorelbine Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Vinorelbine Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
4
Distinct labelers/manufacturers represented
2
Linked representative label
Sagent Pharmaceuticals
Linked label effective
Aug 16, 2024
Composite sections available
23
Linked SPL Set ID
10a70995-e04d-4044-b1dc-c9aa27460397
Linked SPL Document ID
dfa03517-f452-450c-8eb6-d946c0350248
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sagent Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.