Vinorelbine Accord: Uses, Dosage & Side Effects
An oral vinca alkaloid chemotherapy capsule used to treat certain types of non-small cell lung cancer and breast cancer in adults
Vinorelbine Accord contains the active substance vinorelbine, a semi-synthetic vinca alkaloid used in the treatment of cancer. It is prescribed for certain types of non-small cell lung cancer (NSCLC) and certain types of breast cancer in adult patients. Vinorelbine works by disrupting the microtubule structures that cancer cells need to divide and grow, effectively halting tumor proliferation. This oral capsule formulation offers an alternative to intravenous vinorelbine, allowing patients to take some cycles of their chemotherapy at home under medical supervision. Vinorelbine Accord is a prescription-only medication that requires careful monitoring of blood counts and liver function throughout treatment.
Quick Facts: Vinorelbine Accord
Key Takeaways
- Vinorelbine Accord is an oral chemotherapy capsule containing vinorelbine, a vinca alkaloid that stops cancer cells from dividing by disrupting microtubule formation during cell division.
- It is approved for adults with certain types of non-small cell lung cancer (NSCLC) and certain types of breast cancer, used either alone or in combination with other anticancer agents.
- Capsules must be swallowed whole with water and a meal – never chew, crush, or suck them, as the liquid inside is irritating and harmful on direct contact with skin or mucous membranes.
- Blood counts are monitored before every dose because vinorelbine frequently causes neutropenia (low white blood cells), which increases infection risk – treatment may be delayed if counts are too low.
- Women must use effective contraception during treatment and for 7 months after; men for 4 months after. Vinorelbine should not be used during pregnancy or breastfeeding, and men should consider sperm cryopreservation before starting therapy.
What Is Vinorelbine Accord and What Is It Used For?
Vinorelbine Accord contains vinorelbine (as tartrate), a semi-synthetic derivative of the naturally occurring vinca alkaloid vinblastine. The vinca alkaloids are a class of anticancer drugs originally derived from the periwinkle plant (Catharanthus roseus). Vinorelbine was specifically developed to provide potent antitumor activity while having a somewhat more favorable side effect profile compared to older vinca alkaloids, particularly with respect to neurotoxicity. It has been a cornerstone of cancer chemotherapy worldwide for over three decades and remains an important treatment option recommended by major international oncology guidelines including those from the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN).
The mechanism of action of vinorelbine centers on its ability to bind to tubulin, a structural protein that forms the building blocks of microtubules. Microtubules are essential cellular structures with many functions, but they are particularly critical during cell division (mitosis), where they form the mitotic spindle apparatus that separates chromosomes into two daughter cells. Vinorelbine preferentially binds to mitotic microtubules, inhibiting tubulin polymerization and preventing the assembly of the mitotic spindle. Without a functional spindle, dividing cells become arrested at the metaphase stage of mitosis and ultimately undergo programmed cell death (apoptosis). Because cancer cells divide more rapidly than most normal cells, they are disproportionately affected by this mechanism.
A distinctive pharmacological feature of vinorelbine compared to other vinca alkaloids such as vincristine is its relatively greater selectivity for mitotic microtubules over axonal microtubules. Axonal microtubules are found in nerve cells and are essential for nerve function. The lower affinity for axonal microtubules is thought to account for the somewhat reduced neurotoxicity seen with vinorelbine relative to vincristine, although peripheral neuropathy can still occur and remains a clinically important side effect that requires monitoring.
Vinorelbine Accord is approved by regulatory authorities in the European Union and many other countries for the following indications:
- Non-small cell lung cancer (NSCLC): Vinorelbine is used both as a single agent and in combination with other chemotherapy drugs (such as cisplatin) for the treatment of advanced or metastatic NSCLC. Lung cancer is the leading cause of cancer death worldwide, and NSCLC accounts for approximately 80–85% of all lung cancer cases. Oral vinorelbine provides a convenient treatment option that can reduce the need for hospital visits for intravenous chemotherapy, particularly in palliative settings where quality of life is a primary consideration.
- Breast cancer: Vinorelbine is used for the treatment of certain types of advanced or metastatic breast cancer, typically after prior treatment lines have been exhausted or when other chemotherapy regimens are not suitable. It may be used as monotherapy or in combination with other agents. Breast cancer is the most commonly diagnosed cancer in women globally, and vinorelbine remains an important option in the treatment algorithm, particularly for patients who have progressed on anthracycline- and taxane-based therapies.
The oral capsule formulation of vinorelbine represents an important therapeutic advance. Historically, vinorelbine was only available as an intravenous preparation, requiring patients to attend a hospital or infusion center for every treatment cycle. The development of the oral soft capsule allows some treatment cycles to be taken at home, reducing the burden on patients and healthcare systems while maintaining therapeutic efficacy. Clinical studies have demonstrated that oral vinorelbine achieves comparable plasma drug levels and clinical outcomes to the intravenous formulation when dosed appropriately. Many treatment protocols now use an initial intravenous dose followed by oral maintenance, or alternate between intravenous and oral administration.
The oral capsule formulation of vinorelbine allows some treatment cycles to be taken at home rather than in a hospital setting. However, this does not make vinorelbine a less potent medication – it is still a powerful chemotherapy drug that requires careful medical supervision, regular blood tests, and strict adherence to handling precautions. Never adjust your dose or schedule without consulting your oncologist.
What Should You Know Before Taking Vinorelbine Accord?
Contraindications
There are specific situations in which Vinorelbine Accord must not be used. Understanding these absolute contraindications is essential for patient safety and should be discussed thoroughly with your oncologist before treatment begins.
- Hypersensitivity: Do not take Vinorelbine Accord if you are allergic to vinorelbine, any other vinca alkaloid (such as vincristine or vinblastine), or any of the other ingredients in the capsule (listed in the ingredients section below).
- Breastfeeding: Vinorelbine Accord must not be used while breastfeeding. Vinorelbine and its metabolites may pass into breast milk and could harm the nursing infant.
- Gastrointestinal surgery or malabsorption: Do not take oral vinorelbine if you have had surgery on your stomach or small intestine, or if you have a disease that significantly affects absorption from the gastrointestinal tract. These conditions can alter how your body absorbs the medication, potentially leading to unpredictable drug levels.
- Severe neutropenia or recent serious infection: Treatment must not be started if your neutrophil count is below the required threshold or if you have had a severe infection within the preceding two weeks. Vinorelbine further suppresses the immune system and could worsen an existing infection or make you vulnerable to life-threatening sepsis.
- Thrombocytopenia: Vinorelbine must not be used if you have significantly low platelet counts, as this increases the risk of serious bleeding complications.
- Yellow fever vaccination: You must not receive the yellow fever vaccine during treatment with vinorelbine, nor should you have recently been vaccinated against yellow fever before starting treatment. The combination can lead to a potentially fatal vaccine-strain infection due to immunosuppression.
- Long-term oxygen therapy: Vinorelbine Accord is contraindicated in patients receiving continuous supplemental oxygen therapy, as this combination has been associated with increased pulmonary toxicity risk.
Warnings and Precautions
The liquid inside Vinorelbine Accord capsules is irritating and can be harmful if it contacts your skin, mucous membranes, or eyes. Always check that capsules are intact before opening the blister pack. Never chew or suck the capsules. If a capsule is damaged, do not swallow it – return it to your doctor or pharmacist. If capsule contents contact your skin or eyes, wash the area immediately and thoroughly with water and contact your doctor.
Before and during treatment with Vinorelbine Accord, discuss the following with your doctor:
- History of heart disease: Tell your doctor if you have previously had a heart attack (myocardial infarction) or severe chest pain (angina pectoris). Vinorelbine can occasionally cause cardiac events including ischemia, and patients with pre-existing cardiac conditions may be at increased risk.
- Reduced functional capacity: If your ability to perform everyday activities is severely impaired, your doctor will carefully assess whether vinorelbine treatment is appropriate for you, as the side effects may further impact your quality of life.
- Liver disease or prior liver radiation: Vinorelbine is extensively metabolized by the liver. If you have liver problems or have previously received radiation therapy that included the liver in the treatment field, your doctor may need to adjust your dose or monitor you more closely, as impaired liver function can lead to higher drug levels and increased toxicity.
- Signs of infection: Report any symptoms of infection (such as fever, chills, joint pain, cough) immediately to your doctor. Vinorelbine suppresses the immune system, and infections during treatment can rapidly become serious or life-threatening if not treated promptly.
- Vaccination: Several vaccines, particularly live or attenuated vaccines, are not recommended during treatment with vinorelbine due to the risk of vaccine-strain infection. Discuss your vaccination status and any planned vaccinations with your oncologist.
- Severe liver disease unrelated to cancer: If you have significant liver disease that is not caused by your cancer (such as cirrhosis or hepatitis), your doctor will carefully evaluate the risks and benefits of treatment, as severe hepatic impairment can dramatically alter drug metabolism.
- Pregnancy: If you are pregnant or think you may be pregnant, inform your doctor immediately. Vinorelbine can cause harm to the developing fetus and should not be used during pregnancy (see Pregnancy and Breastfeeding section below).
Before every dose of Vinorelbine Accord, your doctor will order blood tests to check your white blood cell count (neutrophils and leukocytes), platelet count, and other blood parameters. If your blood counts are too low, your treatment will be delayed until they recover to safe levels. Additional monitoring tests will be performed as needed throughout your treatment course.
Children and Adolescents
Vinorelbine Accord is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of oral vinorelbine have not been established in this age group, and pediatric cancer patients should receive treatment with agents specifically studied and approved for their condition and age range.
Pregnancy and Breastfeeding
Vinorelbine Accord should not be used during pregnancy. As a cytotoxic drug that interferes with cell division, vinorelbine has the potential to cause birth defects and harm the developing embryo or fetus. If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medication. Your oncologist will discuss the serious risks to the unborn child and alternative treatment options.
Women of childbearing potential must use highly effective contraception during treatment with Vinorelbine Accord and for at least 7 months after the last dose. This extended period reflects the time needed for the drug and its metabolites to be fully eliminated from the body.
Men being treated with Vinorelbine Accord are advised not to father children during treatment and for at least 4 months after the final dose. Vinorelbine may affect sperm production and quality, potentially impairing fertility. Men should discuss the option of sperm cryopreservation (freezing sperm samples) with their doctor before starting treatment, as this provides a safeguard against possible long-term fertility effects.
Breastfeeding is contraindicated during treatment with Vinorelbine Accord. It is not known whether vinorelbine passes into human breast milk, but given its cytotoxic properties, a risk to the breastfed infant cannot be excluded.
Driving and Operating Machinery
No formal studies have been conducted on the effects of vinorelbine on the ability to drive or operate machinery. However, you should not drive if you feel unwell or if your doctor advises against it. Some side effects of vinorelbine, such as fatigue, nausea, dizziness, and visual disturbances, may impair your ability to drive safely or operate machinery. You are responsible for assessing your own fitness to drive and should read all the side effect information in this guide before making that judgment.
Important Information About Ingredients
Sorbitol: Vinorelbine Accord capsules contain small amounts of sorbitol (8.03 mg in the 20 mg capsule, 13.65 mg in the 30 mg capsule, and 24.09 mg in the 80 mg capsule). This quantity is well below the threshold that would cause gastrointestinal effects in most patients.
Alcohol (ethanol): Each capsule contains a small amount of alcohol (2.89 mg in the 20 mg capsule, 4.35 mg in the 30 mg capsule, and 11.56 mg in the 80 mg capsule). The amount of alcohol per capsule is equivalent to less than 1 mL of beer or wine and has no noticeable effects.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is essentially sodium-free.
How Does Vinorelbine Accord Interact with Other Drugs?
Tell your doctor about all medicines you are currently taking, have recently taken, or might take, including over-the-counter products and herbal supplements. Vinorelbine is extensively metabolized by the liver enzyme CYP3A4, and medications that affect this enzyme can significantly alter vinorelbine blood levels, leading to either increased toxicity or reduced effectiveness. Your oncologist will carefully review your medication list before starting treatment.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Itraconazole, Ketoconazole (strong CYP3A4 inhibitors) | Increased vinorelbine plasma levels, greater risk of toxicity (especially neutropenia and neurotoxicity) | Avoid combination; if unavoidable, monitor closely with dose reduction consideration |
| Rifampicin (strong CYP3A4 inducer) | Decreased vinorelbine plasma levels, potentially reduced anticancer efficacy | Avoid combination if possible; efficacy may be significantly diminished |
| Phenytoin (antiepileptic / CYP3A4 inducer) | Reduced vinorelbine levels; risk of decreased phenytoin absorption when combined with cytotoxic agents | Monitor phenytoin levels and vinorelbine efficacy closely; dose adjustments may be needed |
| Mitomycin C (anticancer agent) | Increased risk of severe bronchospasm and pulmonary toxicity | Use with extreme caution; monitor respiratory function closely |
| Live vaccines (e.g., yellow fever, MMR, BCG) | Risk of fatal vaccine-strain infection due to immunosuppression | Yellow fever vaccine is absolutely contraindicated; avoid all live vaccines during treatment |
Other Important Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Anticoagulants (e.g., warfarin) | Altered anticoagulant effect; cancer patients have inherently higher thrombotic risk | Monitor INR/coagulation parameters frequently; dose adjustments may be required |
| Lapatinib (anticancer agent) | Possible increased vinorelbine exposure and additive toxicity | Use with caution; increased monitoring for neutropenia recommended |
| Tacrolimus, Ciclosporin (immunosuppressants) | Additive immunosuppression; increased infection risk | Monitor closely for signs of infection; consider prophylactic antimicrobials |
| Other myelosuppressive agents | Additive bone marrow suppression; increased risk of severe neutropenia, anemia, thrombocytopenia | Monitor blood counts more frequently; growth factor support may be needed |
When vinorelbine is used in combination with cisplatin or other platinum-based chemotherapy agents (a common regimen in NSCLC), the combined myelosuppressive effects must be carefully managed. Your oncologist will determine appropriate doses and schedules to balance anticancer efficacy with manageable toxicity. Supportive measures such as granulocyte colony-stimulating factor (G-CSF) may be used to reduce the risk of severe neutropenia.
What Is the Correct Dosage of Vinorelbine Accord?
Before and during treatment with Vinorelbine Accord, your doctor will perform blood tests to determine when it is safe to administer your next dose and to calculate the appropriate dose for you. The dose is based on your body surface area (BSA), which your doctor calculates from your height and weight. Your doctor will tell you how many capsules and which strength to take.
Monotherapy Dosing (Single Agent)
Induction Phase (First 3 Doses)
Dose: 60 mg/m² body surface area, taken once weekly as a single dose
Duration: First 3 weekly doses
Your doctor will assess your tolerance during this phase by monitoring blood counts and any side effects.
Maintenance Phase (After 3rd Dose)
Dose: May be increased to 80 mg/m² body surface area, once weekly
Condition: Only if the 60 mg/m² dose is well tolerated, as assessed by your oncologist
If significant toxicity occurs, the dose may remain at 60 mg/m² or be further adjusted at your doctor’s discretion.
Combination Therapy Dosing
Vinorelbine with Other Anticancer Agents
Dose: Determined by your oncologist based on the specific combination regimen
Note: When used in combination, the dose may differ from monotherapy dosing and will depend on the protocol being followed and the other agents involved
A total weekly dose of 160 mg must never be exceeded, regardless of the dosing regimen. You should never take Vinorelbine Accord more than once per week. Always follow your oncologist’s instructions precisely regarding the number and strength of capsules to take.
How to Take Vinorelbine Accord
The correct administration of Vinorelbine Accord capsules is essential for both safety and effectiveness. Follow these instructions carefully:
- Swallow capsules whole with water, preferably with a meal. Taking the medication with food helps reduce nausea.
- Do not take with hot drinks as heat can cause the capsules to dissolve too quickly, potentially releasing the contents prematurely.
- Never chew, crush, or suck the capsules. The liquid inside is a potent cytotoxic agent that is irritating and potentially harmful on direct contact.
- Check capsule integrity before opening the blister pack. If a capsule appears damaged, cracked, or leaking, do not swallow it. Return damaged capsules to your doctor or pharmacist.
- If you accidentally chew or suck a capsule, rinse your mouth thoroughly with water and contact your doctor immediately.
- If capsule contents contact your skin, mucous membranes, or eyes, wash the area immediately and thoroughly with copious amounts of water.
Managing Nausea
Nausea and vomiting can occur with Vinorelbine Accord. If your doctor has prescribed anti-nausea medication (antiemetics), always take it according to their instructions. Taking Vinorelbine Accord with a meal can also help reduce nausea. If you vomit within a few hours of taking your dose, contact your doctor – do not take an additional dose on your own.
Missed Dose
Do not take a double dose to make up for a forgotten dose. If you miss your scheduled weekly dose, contact your doctor, who will advise whether you should take it at another time or skip that dose entirely. The timing of chemotherapy doses is carefully planned, and any changes to the schedule should only be made under medical supervision.
Overdose
If you take more Vinorelbine Accord than prescribed, or if a child accidentally ingests the medication, contact your doctor, hospital, or poison control center immediately. Overdose can lead to serious and potentially life-threatening symptoms, including severe bone marrow suppression (causing dangerously low blood counts and susceptibility to life-threatening infections), severe constipation, and paralytic ileus (complete bowel obstruction). There is no specific antidote for vinorelbine overdose – treatment is supportive and focuses on managing complications as they arise.
Children
Vinorelbine Accord is intended for adult patients only. It is not recommended for use in children and adolescents under 18 years of age.
Elderly Patients
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly myelosuppression and neurotoxicity. Your oncologist will carefully assess your overall health status and organ function when determining the appropriate dose and monitoring schedule.
Stopping Treatment
Your oncologist will determine when to stop treatment based on your cancer’s response, your tolerance of the medication, and your overall clinical situation. If you wish to discontinue treatment earlier than planned, discuss alternative options with your doctor before making any changes. Abruptly stopping cancer chemotherapy without medical guidance can affect treatment outcomes.
What Are the Side Effects of Vinorelbine Accord?
Like all medicines, Vinorelbine Accord can cause side effects, although not everybody gets them. Some side effects can be serious and require immediate medical attention. It is important to be aware of the warning signs and to report any concerns to your medical team promptly.
Signs of infection such as fever, chills, and cough. Severe constipation with abdominal pain and no bowel movement for several days. Severe dizziness or feeling faint when standing up (sign of dangerously low blood pressure). Severe chest pain that is new or unusual, which may indicate a heart attack. Difficulty breathing with rash, itching, or facial swelling (allergic reaction). Chest pain, shortness of breath, and fainting, which may indicate a pulmonary embolism. Headache, confusion, seizures, visual disturbances, and high blood pressure, which may be symptoms of posterior reversible encephalopathy syndrome (PRES).
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Infections at various sites in the body
- Nausea, vomiting, diarrhea, constipation, abdominal pain
- Mouth inflammation (stomatitis)
- Decreased red blood cell count (anemia) causing paleness, weakness, or breathlessness
- Decreased platelet count (thrombocytopenia) increasing risk of bleeding or bruising
- Decreased white blood cell count (neutropenia, leukopenia) increasing risk of infection
- Loss of certain reflexes, sometimes with altered sensation in the skin
- Hair loss, usually mild
- Fatigue and tiredness
- Fever
- General feeling of being unwell (malaise)
- Weight loss and loss of appetite
Common
May affect up to 1 in 10 people
- Difficulty coordinating movements
- Visual disturbances
- Shortness of breath, cough
- Difficulty urinating, other urogenital symptoms
- Sleep difficulties (insomnia)
- Headache, dizziness, altered taste perception
- Inflammation of the esophagus, difficulty swallowing food and liquids
- Skin reactions
- Chills
- Weight gain
- Joint pain, jaw pain, muscle pain
- Pain at various sites including the tumor site
- High blood pressure (hypertension)
- Liver effects (abnormal liver function tests)
Uncommon
May affect up to 1 in 100 people
- Heart failure causing breathlessness and ankle swelling
- Heart rhythm disturbances (arrhythmias)
- Ataxia (loss of muscle control associated with abnormal gait, speech changes, and abnormal eye movements)
Not Known
Frequency cannot be estimated from available data
- Sepsis (blood poisoning) with high fever and deterioration in general health
- Myocardial infarction (heart attack)
- Gastrointestinal bleeding
- Hyponatremia (low sodium levels) causing weakness, muscle twitching, fatigue, confusion, or loss of consciousness – in some cases caused by syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- Posterior reversible encephalopathy syndrome (PRES) with headache, confusion, seizures, visual disturbances, and high blood pressure
- Pulmonary embolism (blood clot in the lungs)
Managing Side Effects
Many side effects of vinorelbine can be effectively managed with supportive care. Your oncology team will provide guidance specific to your situation, but general principles include maintaining adequate hydration, using prescribed antiemetics for nausea, reporting fevers above 38°C immediately (as this may indicate neutropenic fever requiring urgent antibiotics), and maintaining good oral hygiene to reduce the severity of stomatitis. Constipation should be addressed proactively with dietary measures and laxatives if needed, as severe constipation can progress to paralytic ileus, a serious complication.
Your medical team will monitor your blood counts regularly, and dose delays or reductions will be implemented if your counts are too low. This careful monitoring is a normal and essential part of chemotherapy treatment – it does not mean the treatment is failing. Growth factor support (G-CSF) may be considered if neutropenia is recurrent or severe.
It is important to report suspected side effects after a medicine has been authorized. This allows ongoing monitoring of the medicine’s benefit-risk balance. Healthcare professionals and patients can report side effects to their national pharmacovigilance authority. In the EU, reports can be submitted through national reporting systems. In the US, reports can be made to the FDA MedWatch program.
How Should You Store Vinorelbine Accord?
Proper storage of Vinorelbine Accord is essential for both safety and medication effectiveness. Because the capsules contain a potent cytotoxic substance, special care must be taken to ensure they are stored securely and handled properly at all times.
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not store at room temperature for extended periods.
- Keep away from children: This is critically important for Vinorelbine Accord, as accidental ingestion by a child could be extremely dangerous and potentially fatal. Always store the medication in a secure location within the refrigerator.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month.
- Disposal: Do not dispose of vinorelbine capsules in household waste or down the drain. As a cytotoxic drug, it requires special handling for environmental protection. Return any unused or expired capsules to your pharmacist, who will dispose of them through appropriate hazardous waste channels.
If you are collecting your medication from the pharmacy, ensure it is transported in a cool bag or insulated container, especially in warm weather, to maintain the required refrigeration temperature during transit. Ask your pharmacist for guidance if you are unsure about transport conditions.
What Does Vinorelbine Accord Contain?
Active Ingredient
Each soft capsule contains vinorelbine (as vinorelbine tartrate) in one of three strengths:
- 20 mg capsule: Contains 20 mg vinorelbine
- 30 mg capsule: Contains 30 mg vinorelbine
- 80 mg capsule: Contains 80 mg vinorelbine
Inactive Ingredients
Capsule fill solution: Macrogol (polyethylene glycol), glycerol, anhydrous ethanol, and purified water.
Capsule shell: Gelatin, glycerol, liquid sorbitol (partially dehydrated, E 420), titanium dioxide (E 171), yellow iron oxide (E 172) [20 mg and 80 mg capsules only], red iron oxide (E 172) [30 mg capsule only].
Printing ink: Shellac (E 904), black iron oxide (E 172), ammonium hydroxide (E 527), and propylene glycol (E 1520).
Capsule Appearance and Identification
| Strength | Color | Shape & Size | Imprint |
|---|---|---|---|
| 20 mg | Light brown, opaque | Oval, 9.3 mm × 6.7 mm | “JJ1” in black ink |
| 30 mg | Pink, opaque | Oblong, 15 mm × 6.2 mm | “JJ2” in black ink |
| 80 mg | Light yellow, opaque | Oblong, 20.5 mm × 8 mm | “JJ3” in black ink |
All capsules are smooth, soft gelatin capsules containing a clear, colorless liquid. Vinorelbine Accord is available in blister packs containing 1, 2, 3, or 4 soft capsules. Not all pack sizes may be marketed in all countries.
Marketing Authorization Holder: Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands.
Frequently Asked Questions About Vinorelbine Accord
Both oral and intravenous vinorelbine contain the same active substance and work by the same mechanism. The oral capsule formulation has a bioavailability of approximately 60–80% compared to the IV form, meaning the oral dose is adjusted to achieve similar blood levels. Clinical studies have shown comparable efficacy between the two formulations. The main advantages of oral vinorelbine are convenience (can be taken at home) and avoidance of venous access issues. However, the oral form requires careful capsule handling precautions and patients must be able to swallow capsules whole. Your oncologist will determine which formulation is most appropriate for your treatment plan.
Vinorelbine commonly causes neutropenia (low white blood cell counts), which significantly increases your risk of serious or even life-threatening infections. Blood tests before each dose allow your doctor to check that your neutrophil count, platelet count, and other blood parameters have recovered to safe levels. If your counts are too low, your treatment will be delayed by one or more weeks until they recover. This careful monitoring is a standard and essential part of chemotherapy treatment – it helps keep you safe by ensuring you are fit enough to receive each dose.
Yes, it is actually recommended to take Vinorelbine Accord with a meal. Taking the capsules with food can help reduce nausea, which is one of the most common side effects. Swallow the capsules whole with water. Do not take them with hot drinks (such as tea, coffee, or hot chocolate) because the heat can cause the gelatin capsule to dissolve prematurely, potentially releasing the cytotoxic contents before they reach the correct part of your digestive system.
If you vomit within a few hours of taking Vinorelbine Accord, contact your doctor. Do not take a replacement dose on your own. Your doctor will assess the situation and decide whether a replacement dose is needed, as taking an extra dose could lead to overdose and increased toxicity. If your doctor has prescribed anti-nausea medication, make sure you are taking it as directed – this is an important part of managing your treatment.
The duration of treatment with Vinorelbine Accord varies significantly depending on your type and stage of cancer, your response to treatment, and how well you tolerate the medication. Your oncologist will determine the optimal treatment duration for your specific situation. Treatment is typically continued as long as it is providing clinical benefit and the side effects are manageable. Regular assessments, including imaging scans, will be performed to evaluate how well the cancer is responding. If you wish to stop treatment earlier, always discuss this with your doctor before making any changes.
All information in this guide is based on the approved Summary of Product Characteristics (SmPC) for Vinorelbine Accord as published by the European Medicines Agency (EMA), supplemented by international clinical guidelines from ESMO (European Society for Medical Oncology), NCCN (National Comprehensive Cancer Network), and peer-reviewed medical literature. The content has been reviewed by the iMedic Medical Editorial Team, which includes board-certified oncologists and clinical pharmacologists. All medical claims follow the GRADE evidence framework, with the highest level of evidence (1A) based on systematic reviews of randomized controlled trials.
References
- European Medicines Agency (EMA). Vinorelbine Accord – Summary of Product Characteristics. Last updated 2025.
- Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2024;35(10):891–934.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 3.2025.
- Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Annals of Oncology. 2020;31(12):1623–1649.
- Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. Journal of the National Cancer Institute. 2003;95(5):362–372.
- Jassem J, Ramlau R, Karnicka-Mlodkowska H, et al. A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients. Annals of Oncology. 2001;12(10):1375–1381.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: World Health Organization.
- British National Formulary (BNF). Vinorelbine. National Institute for Health and Care Excellence (NICE). Accessed January 2026.
Medical Editorial Team
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Written by the iMedic Medical Editorial Team, specialists in oncology and clinical pharmacology
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Reviewed by the iMedic Medical Review Board according to international guidelines (WHO, EMA, ESMO, NCCN)
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