Vinorelbine medac
Oral chemotherapy for non-small cell lung cancer and breast cancer
Vinorelbine medac is an oral chemotherapy medicine containing the active substance vinorelbine, a semi-synthetic vinca alkaloid. It is used to treat certain types of non-small cell lung cancer (NSCLC) and certain types of breast cancer in adults over 18 years. It works by disrupting cancer cell division, ultimately leading to cell death. This guide provides comprehensive, evidence-based information about Vinorelbine medac, including its uses, dosage, side effects, drug interactions, and storage requirements.
Quick Facts
Key Takeaways
- Vinorelbine medac is an oral chemotherapy medicine used for non-small cell lung cancer and breast cancer in adults
- Capsules must be swallowed whole with water and a light meal — never chewed, crushed, or taken with hot drinks
- The most common side effects include low blood cell counts, nausea, fatigue, and hair loss; regular blood monitoring is mandatory
- Must be stored in a refrigerator (2–8 °C) in original packaging, protected from light
- Contraindicated during breastfeeding; effective contraception is required during and after treatment for both men and women
What Is Vinorelbine medac and What Is It Used For?
Vinorelbine medac contains the active substance vinorelbine (as tartrate), which belongs to a group of anticancer medicines known as vinca alkaloids. These medicines are derived from the periwinkle plant (Catharanthus roseus) and have been used in cancer therapy for decades. Vinorelbine is a semi-synthetic derivative specifically designed to maintain strong antitumor activity while reducing certain side effects, particularly neurotoxicity, compared to earlier vinca alkaloids such as vincristine and vinblastine.
The mechanism of action of vinorelbine involves binding to tubulin, a protein essential for the formation of microtubules within cells. Microtubules are critical structural components of the mitotic spindle, which is responsible for separating chromosomes during cell division. By inhibiting microtubule polymerization, vinorelbine blocks cells at the G2-M phase of the cell cycle, preventing mitosis and ultimately leading to cancer cell death (apoptosis). Importantly, vinorelbine shows preferential affinity for mitotic microtubules over axonal microtubules, which contributes to its relatively lower neurotoxicity profile compared to other vinca alkaloids.
Approved Indications
Vinorelbine medac is approved for the treatment of:
- Non-small cell lung cancer (NSCLC) — The most common type of lung cancer, representing approximately 80–85% of all lung cancers. Vinorelbine can be used as a single agent or in combination with other chemotherapy drugs such as cisplatin, particularly in patients with advanced (stage IIIB or IV) disease. The combination of vinorelbine and cisplatin has been established as a standard first-line regimen based on multiple randomized controlled trials.
- Advanced or metastatic breast cancer — Vinorelbine is used in patients whose disease has progressed after prior anthracycline- and taxane-based chemotherapy regimens. It may be used as monotherapy or in combination with other anticancer agents.
Clinical trials have demonstrated that oral vinorelbine achieves comparable efficacy to intravenous vinorelbine while offering the convenience of home-based administration. A pivotal phase III trial published in the Journal of Clinical Oncology showed that oral vinorelbine provided equivalent overall survival and progression-free survival outcomes compared to the intravenous formulation in NSCLC patients, with a manageable safety profile. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) guidelines both recognize vinorelbine as a treatment option for these indications.
The availability of an oral formulation is particularly significant for patients requiring ongoing chemotherapy, as it reduces the need for repeated hospital visits for intravenous infusions and can improve quality of life during treatment. Your oncologist will determine whether oral vinorelbine is appropriate based on your specific type and stage of cancer, overall health status, and treatment history.
What Should You Know Before Taking Vinorelbine medac?
Before initiating treatment with Vinorelbine medac, your oncologist will conduct a thorough evaluation of your medical history, current health status, and any medications you are taking. This assessment is crucial because vinorelbine is a potent chemotherapy agent that can interact with other drugs and is contraindicated in certain clinical situations. Understanding these considerations will help ensure your safety throughout treatment.
Contraindications
You must not take Vinorelbine medac in the following circumstances:
- Allergy to vinorelbine or other vinca alkaloids — If you have a known hypersensitivity to vinorelbine, other vinca alkaloid chemotherapy drugs (such as vincristine or vinblastine), or any of the excipients in the capsule formulation
- Breastfeeding — Vinorelbine is excreted in breast milk and poses a serious risk to nursing infants. Breastfeeding must be discontinued before starting treatment
- Previous stomach or small bowel surgery, or bowel disease — Conditions affecting the gastrointestinal tract may impair absorption and increase the risk of complications with oral chemotherapy
- Severe neutropenia or thrombocytopenia — Low white blood cell counts (below 1,500/mm³) or low platelet counts significantly increase the risk of life-threatening infections and bleeding
- Severe active infection — Current or recent serious infection (within the past 2 weeks) must be resolved before treatment can begin
- Recent or planned yellow fever vaccination — Live vaccines are contraindicated with immunosuppressive chemotherapy due to the risk of potentially fatal vaccine-derived disease
- Long-term oxygen therapy — Patients requiring continuous supplemental oxygen should not receive vinorelbine due to increased pulmonary toxicity risk
Warnings and Precautions
Inform your doctor before starting Vinorelbine medac if any of the following apply to you:
- You have had a heart attack (myocardial infarction) or severe chest pain (angina pectoris) in the past, as vinorelbine may exacerbate cardiac conditions
- Your ability to perform daily activities is severely impaired (poor performance status), which may affect your tolerance of chemotherapy
- You have received radiation therapy involving the liver, as this may affect how your body processes vinorelbine
- You have symptoms of infection such as fever, chills, or persistent cough, which may indicate neutropenic fever requiring urgent medical attention
- You are planning to receive any vaccines — live attenuated vaccines (such as MMR, varicella, or oral polio) are not recommended during vinorelbine treatment due to the increased risk of severe vaccine-related illness
- You have severe liver disease unrelated to your cancer, as vinorelbine is metabolized primarily by the liver and impaired hepatic function may lead to increased drug levels and toxicity
Before and during treatment with Vinorelbine medac, your blood cell counts will be checked regularly. This monitoring is essential to ensure it is safe for you to continue treatment. If blood test results are unsatisfactory (particularly if neutrophil counts fall below acceptable levels), your treatment may be delayed and additional monitoring performed until values return to normal. Never skip scheduled blood tests.
Pregnancy and Breastfeeding
Vinorelbine medac poses significant reproductive risks and strict precautions must be observed:
- Pregnancy: You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Vinorelbine is expected to cause harm to an unborn child based on its mechanism of action and preclinical data. Treatment during pregnancy should only be considered if the potential benefit to the mother clearly outweighs the risk to the fetus, and only after thorough discussion with your oncologist.
- Breastfeeding: You must not breastfeed while taking Vinorelbine medac. Vinorelbine and its metabolites may be excreted in breast milk, posing a serious risk to the infant.
- Female fertility: Women of childbearing potential must use highly effective contraception during treatment and for at least 7 months after the last dose. A pregnancy test may be required before starting treatment.
- Male fertility: Men are advised not to father children during treatment and for at least 4 months after receiving the last capsule. Men should seek advice about sperm cryopreservation (freezing) before starting treatment, as vinorelbine may impair male fertility.
Driving and Operating Machinery
While no formal studies have been conducted, vinorelbine is not expected to directly impair driving ability based on its pharmacological profile. However, you should not drive or operate machinery if you feel unwell, dizzy, or fatigued — all of which can occur during chemotherapy treatment. Always discuss with your doctor whether it is safe for you to drive during your treatment period, and be aware that some side effects (such as visual changes or dizziness) may affect your ability to drive safely.
Children and Adolescents
Vinorelbine medac is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.
How Does Vinorelbine medac Interact with Other Drugs?
Drug interactions with vinorelbine can alter its effectiveness or increase the risk of serious side effects. Because vinorelbine is metabolized primarily by the CYP3A4 enzyme in the liver, medications that inhibit or induce this enzyme can significantly affect vinorelbine blood levels. Your oncologist must be aware of all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements, to manage potential interactions effectively.
Major Interactions
The following drug interactions are considered clinically significant and require careful monitoring or dose adjustments:
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| Anticoagulants (e.g., warfarin) | Increased bleeding risk | Chemotherapy can affect blood clotting; more frequent INR monitoring required |
| Phenytoin (antiepileptic) | Reduced phenytoin absorption; increased vinorelbine toxicity risk | May lead to seizures from subtherapeutic phenytoin levels; monitor drug levels closely |
| Itraconazole (antifungal) | CYP3A4 inhibition increases vinorelbine levels | Risk of increased myelosuppression and neurotoxicity; dose adjustment may be needed |
| Mitomycin C (chemotherapy) | Additive pulmonary toxicity | Increased risk of bronchospasm and interstitial lung disease; use with extreme caution |
| Lapatinib (targeted therapy) | Additive bone marrow suppression | Increased risk of severe neutropenia; intensive blood monitoring required |
| Ciclosporin / Tacrolimus | Immunosuppression potentiation | Risk of excessive immunosuppression and serious infections; close monitoring essential |
Minor Interactions and General Considerations
Beyond the major interactions listed above, several additional considerations are important:
- Other CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir, grapefruit juice) may increase vinorelbine blood levels, potentially leading to greater toxicity. Inform your doctor if you are taking any of these.
- CYP3A4 inducers (e.g., rifampicin, carbamazepine, St. John's Wort) may decrease vinorelbine levels, potentially reducing its effectiveness against cancer.
- Other myelosuppressive agents — Concurrent use with other chemotherapy drugs or medications known to suppress bone marrow function can amplify the reduction in blood cell counts, increasing the risk of infection and bleeding.
- Live vaccines are contraindicated during treatment. Inactivated vaccines may be administered, but the immune response may be reduced.
Always carry an up-to-date medication list and show it to every healthcare professional you see. This includes your oncologist, general practitioner, pharmacist, dentist, and any specialists. Even seemingly harmless over-the-counter medications or herbal supplements can interact with vinorelbine.
What Is the Correct Dosage of Vinorelbine medac?
The dosage of Vinorelbine medac is individually determined by your oncologist based on your body surface area (calculated from your height and weight), blood test results, overall health status, and the specific treatment protocol being followed. It is essential that you take this medicine exactly as prescribed.
Adults
Standard Dosing Protocol
- Initial dose (weeks 1–3): 60 mg/m² body surface area, administered once weekly
- Subsequent doses (from week 4): If well tolerated, the dose may be increased to 80 mg/m² once weekly
- Maximum weekly dose: Must never exceed 160 mg per week, regardless of body surface area
- Frequency: Once per week only — never more frequently
The available capsule strengths (20 mg, 30 mg, and 80 mg) allow your doctor to tailor the dose precisely to your body surface area. Your doctor will tell you exactly how many capsules of each strength to take.
| BSA (m²) | Dose at 60 mg/m² | Dose at 80 mg/m² |
|---|---|---|
| 1.1–1.3 | 80 mg | 100 mg |
| 1.3–1.5 | 80 mg | 120 mg |
| 1.5–1.7 | 100 mg | 130 mg |
| 1.7–1.9 | 110 mg | 150 mg |
| ≥1.9 | 120 mg | 160 mg |
How to Take the Capsules
Proper handling and administration of Vinorelbine medac capsules is crucial, as the medicine inside can be irritating:
- Check the capsule: Before opening the blister pack, inspect the capsule to ensure it is not damaged. Do not swallow damaged capsules; return them to your pharmacist.
- Open the blister: Cut along the black dotted line with scissors, peel off the soft plastic film, and push the capsule through the aluminium foil.
- Swallow whole: Swallow the capsule whole with water, preferably with a light meal. Do not take it with a hot drink, as this can dissolve the capsule too quickly.
- Do not chew or suck the capsules. If you accidentally chew or suck a capsule, rinse your mouth thoroughly and contact your doctor immediately.
- Skin contact: If the liquid from a damaged capsule comes into contact with your skin, eyes, or mucous membranes, wash the affected area thoroughly with water immediately and contact your doctor.
Anti-nausea Medication
If your doctor has prescribed anti-emetic (anti-sickness) medication, take it exactly as directed. Taking Vinorelbine medac with a light meal can also help reduce nausea. Vomiting is common with this treatment; if you vomit within a few hours of taking the capsule, contact your doctor immediately. Do not take a replacement dose without medical advice.
Missed Dose
If you forget to take your scheduled dose, do not take a double dose to compensate. Contact your oncologist, who will advise whether to take the dose at an alternative time or skip it entirely and resume your regular schedule the following week.
Overdose
If you or someone else has taken too much Vinorelbine medac, seek immediate medical attention or contact your local poison control center. Overdose can lead to severe bone marrow suppression with dangerously low white blood cell counts, increasing the risk of life-threatening infections. Severe constipation and other gastrointestinal complications may also develop. There is no specific antidote; treatment is supportive.
Children
Vinorelbine medac is not approved for use in patients under 18 years of age. The safety and efficacy of vinorelbine in pediatric populations have not been established.
Elderly Patients
No specific dose adjustment is routinely recommended for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly myelosuppression (low blood counts) and neurotoxicity. Your oncologist will monitor you closely and may adjust the dose or treatment schedule based on your tolerance and blood test results.
What Are the Side Effects of Vinorelbine medac?
Side effects are a common part of chemotherapy treatment. Not everyone will experience all of the side effects listed below, and their severity can vary widely between individuals. Your oncology team will monitor you regularly and can provide supportive treatments to manage many side effects. Always report any new or worsening symptoms promptly.
Contact your doctor or go to the emergency department immediately if you experience any of the following while taking Vinorelbine medac:
- Signs of infection: fever (38°C or above), chills, persistent cough, sore throat
- Severe constipation with abdominal pain and no bowel movements for several days
- Severe dizziness or feeling faint when standing (signs of dangerously low blood pressure)
- Severe chest pain not typical for you (may indicate a cardiac event)
- Difficulty breathing, widespread rash, swelling of face, lips, or throat (signs of a severe allergic reaction)
- Chest pain, shortness of breath, and fainting (possible pulmonary embolism)
- Severe headache, confusion, seizures, visual disturbances, and high blood pressure (possible posterior reversible encephalopathy syndrome — PRES)
Very Common
Affects more than 1 in 10 patients
- Decreased white blood cells (neutropenia) — increases infection susceptibility
- Decreased red blood cells (anemia) — causing pallor, weakness, shortness of breath
- Decreased platelets (thrombocytopenia) — increased bleeding or bruising risk
- Nausea and vomiting
- Constipation and abdominal pain
- Diarrhea
- Mouth inflammation (stomatitis/mucositis)
- Hair loss (usually mild)
- Fatigue and general malaise
- Fever
- Loss of appetite and weight loss
- Loss of certain reflexes, altered sense of touch (peripheral neuropathy)
- Infections at various sites
Common
Affects 1 to 10 in 100 patients
- Difficulty coordinating muscle movements
- Visual changes
- Shortness of breath and cough
- Difficulty urinating, other urinary tract symptoms
- Sleep difficulties (insomnia)
- Headache, dizziness, taste changes
- Inflammation of the esophagus, difficulty swallowing
- Skin reactions
- Chills
- Joint pain, jaw pain, muscle pain
- Pain at various sites and at the tumor site
- High blood pressure
- Abnormal liver function tests
- Weight gain
Uncommon
Affects 1 to 10 in 1,000 patients
- Heart failure — may cause shortness of breath and ankle swelling
- Irregular heartbeat (cardiac arrhythmia)
- Ataxia — problems with muscle coordination, abnormal gait, speech changes, and unusual eye movements
Rare / Frequency Unknown
Reported cases, frequency cannot be established
- Sepsis (blood infection) with high fever and deteriorating general health
- Myocardial infarction (heart attack), sometimes with fatal outcome
- Gastrointestinal bleeding
- Hyponatremia (low sodium levels) — causing weakness, muscle twitching, fatigue, confusion, and loss of consciousness
- SIADH (syndrome of inappropriate antidiuretic hormone secretion) — a rare hormonal complication leading to fluid retention and dangerously low sodium
- Posterior reversible encephalopathy syndrome (PRES)
- Pulmonary embolism (blood clot in the lungs)
Managing Side Effects
Many side effects of vinorelbine can be managed effectively with supportive care. Your oncology team may prescribe anti-emetics for nausea, laxatives for constipation, or growth factors (such as G-CSF) for severe neutropenia. Maintaining good oral hygiene can help reduce the severity of mouth inflammation. Always report side effects to your healthcare team rather than trying to manage them alone, as some require prompt medical intervention.
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. You can report side effects to your national medicines regulatory authority (e.g., the FDA in the United States, MHRA in the United Kingdom, or EMA in Europe) or through your healthcare provider.
How Should You Store Vinorelbine medac?
Proper storage of Vinorelbine medac is essential to maintain the stability and safety of this cytotoxic medicine. Because the capsule contents can be harmful if the capsule is damaged, careful handling and storage are particularly important.
- Temperature: Store in a refrigerator at 2–8 °C (36–46 °F). Do not freeze.
- Light protection: Keep in the original blister packaging to protect from light, as vinorelbine is light-sensitive.
- Child safety: Keep out of the sight and reach of children at all times. This is a cytotoxic medicine that can be harmful if handled improperly.
- Expiry date: Do not use after the expiry date printed on the blister and carton (after "EXP"). The expiry date refers to the last day of the stated month.
- Disposal: Unused or damaged capsules must be returned to a pharmacy or your healthcare provider for safe disposal. For safety reasons, this medicine must not be disposed of via household waste or sewage. Cytotoxic medicines require specialized disposal to protect the environment and prevent accidental exposure.
What Does Vinorelbine medac Contain?
Each Vinorelbine medac soft capsule contains vinorelbine as the active substance in the form of vinorelbine tartrate. Understanding the full composition is important for patients with known allergies or intolerances to specific excipients.
Active Substance
- Vinorelbine medac 20 mg: Each soft capsule contains vinorelbine tartrate equivalent to 20 mg vinorelbine
- Vinorelbine medac 30 mg: Each soft capsule contains vinorelbine tartrate equivalent to 30 mg vinorelbine
- Vinorelbine medac 80 mg: Each soft capsule contains vinorelbine tartrate equivalent to 80 mg vinorelbine
Inactive Ingredients (Excipients)
Capsule fill: anhydrous ethanol, purified water, glycerol, macrogol 400
Capsule shell: gelatin, glycerol, partially dehydrated liquid sorbitol, titanium dioxide (E171), purified water. The 20 mg and 80 mg capsules also contain yellow iron oxide (E172); the 30 mg capsule contains red iron oxide (E172).
Printing ink: shellac glaze, black iron oxide (E172), propylene glycol, medium-chain triglycerides
Capsule Appearance
| Strength | Shape & Color | Size | Imprint |
|---|---|---|---|
| 20 mg | Oval, light brown | 9.0 mm × 7.0 mm | "20" in black ink |
| 30 mg | Oblong, pink | 15.0 mm × 6.0 mm | "30" in black ink |
| 80 mg | Oblong, light yellow | 20.0 mm × 8.0 mm | "80" in black ink |
Sorbitol and Alcohol Content
This medicine contains small amounts of both sorbitol and ethanol (alcohol):
- Sorbitol: 10.54 mg (20 mg capsule), 15.96 mg (30 mg capsule), 29.35 mg (80 mg capsule). These amounts are too small to have any noticeable clinical effect.
- Ethanol: The capsules contain approximately 2.85% alcohol by weight. The 20 mg capsule contains 5 mg, the 30 mg capsule contains 7.5 mg, and the 80 mg capsule contains 20 mg of ethanol. These are equivalent to less than 1 ml of beer or wine and are unlikely to produce noticeable effects.
Pack Sizes
Vinorelbine medac 20 mg and 30 mg capsules are available in packs containing 1 blister with 1 capsule, or 4 blisters with 1 capsule each. Vinorelbine medac 80 mg capsules are available in packs containing 1 blister with 1 capsule. Not all pack sizes may be marketed in every country.
Marketing Authorization Holder and Manufacturer
medac Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany. This medicine is authorized within the European Economic Area under similar names including Vinorelbine medac, Vinorelbin medac, and Vinorelbina medac depending on the country.
Frequently Asked Questions About Vinorelbine medac
Vinorelbine medac is a chemotherapy medicine used to treat certain types of non-small cell lung cancer (NSCLC) and advanced or metastatic breast cancer in adults over 18 years of age. It belongs to the vinca alkaloid class of anticancer drugs and works by preventing cancer cells from dividing. Your oncologist will determine if Vinorelbine medac is appropriate for your specific type and stage of cancer.
The most common side effects (affecting more than 1 in 10 patients) include low white blood cell counts (increasing infection risk), low red blood cell counts (anemia), nausea, vomiting, constipation, diarrhea, mouth inflammation, mild hair loss, fatigue, fever, loss of appetite, and peripheral neuropathy (changes in sensation). Your oncology team will monitor your blood counts regularly and can provide medications to help manage many of these side effects.
Swallow the capsules whole with water, preferably with a light meal. Never chew, crush, or suck on the capsules. Avoid taking them with hot drinks as this dissolves the capsule coating too quickly. If you vomit shortly after taking the capsule, do not take another dose — contact your doctor. If a capsule appears damaged, do not take it; return it to your pharmacy.
No. Vinorelbine medac is expected to cause harm to an unborn child. Women of childbearing potential must use highly effective contraception during treatment and for at least 7 months after the last dose. Men receiving treatment should avoid fathering children during treatment and for at least 4 months after the last capsule. Sperm preservation should be discussed with your doctor before starting treatment. If you become pregnant during treatment, inform your oncologist immediately.
Store Vinorelbine medac in a refrigerator at 2–8 °C (36–46 °F), in the original blister packaging to protect it from light. Keep it out of the reach of children. Do not use the capsules after the expiry date on the packaging. Unused or damaged capsules must be returned to your pharmacist or hospital for safe disposal — never throw them in household waste or flush them, as vinorelbine is a cytotoxic agent that requires specialized handling.
Oral vinorelbine (capsules) and intravenous vinorelbine contain the same active substance and work in the same way. Clinical trials have demonstrated comparable efficacy between the two formulations. The oral form offers the convenience of being taken at home rather than requiring hospital visits for infusions. However, oral bioavailability is approximately 40%, so the oral dose is higher than the intravenous dose to achieve equivalent blood levels. Your oncologist will decide which formulation is most appropriate for your situation.
References and Medical Sources
This article is based on the following evidence-based medical sources. All medical claims are supported by peer-reviewed research and international guidelines.
- European Medicines Agency (EMA). Vinorelbine — Summary of Product Characteristics. European public assessment reports. Available at: www.ema.europa.eu
- Gridelli C, et al. Oral vinorelbine: a non-inferiority randomized phase III study in non-small cell lung cancer. Journal of Clinical Oncology. 2006;24(18_suppl):7015. DOI: 10.1200/jco.2006.24.18_suppl.7015
- Jassem J, et al. Oral vinorelbine in combination with cisplatin: a novel active regimen in advanced non-small cell lung cancer. Annals of Oncology. 2003;14(11):1634-1639.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines — Metastatic Non-Small Cell Lung Cancer. ESMO Guidelines. Updated 2024.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology — Non-Small Cell Lung Cancer. Version 3.2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- British National Formulary (BNF). Vinorelbine. NICE Evidence Services. Available at: bnf.nice.org.uk
- Fumoleau P, et al. Vinorelbine (Navelbine) in the treatment of breast cancer: the European experience. Seminars in Oncology. 1995;22(2 Suppl 5):22-28.
Medical Editorial Team
This article has been written and reviewed by our medical editorial team, which includes board-certified specialists in oncology and clinical pharmacology. All content follows the GRADE evidence framework and adheres to WHO, EMA, and ESMO guidelines.
iMedic Medical Editorial Team — Specialists in oncology, clinical pharmacology, and evidence-based medicine with documented academic backgrounds and clinical experience.
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