Eribulin Advanz Pharma
Microtubule dynamics inhibitor for advanced breast cancer and liposarcoma
Eribulin Advanz Pharma is a prescription-only chemotherapy medicine containing eribulin, a microtubule dynamics inhibitor used to treat locally advanced or metastatic breast cancer and liposarcoma. It is administered intravenously by a healthcare professional. This guide provides comprehensive, evidence-based information about its uses, dosage, side effects, drug interactions, and storage requirements.
Quick Facts
Key Takeaways
- Eribulin is a microtubule dynamics inhibitor used when prior chemotherapy regimens have failed, particularly in metastatic breast cancer and liposarcoma
- It is given as an intravenous injection over 2-5 minutes on days 1 and 8 of each 21-day cycle, with doses based on body surface area
- The most common side effects include neutropenia, fatigue, nausea, and peripheral neuropathy, which require regular blood monitoring
- It must not be used during breastfeeding and effective contraception is required during and for 3 months after treatment
- Multiple brand-name and generic versions exist (HALAVEN, Eribulin STADA, Eribulin EVER Pharma, Eribulin Glenmark, Eribulin Baxter), all containing the same active substance
What Is Eribulin Advanz Pharma and What Is It Used For?
Eribulin Advanz Pharma belongs to the halichondrin class of antineoplastic agents, originally derived from the marine sponge Halichondria okadai. The active substance, eribulin, exerts its anticancer effects through a unique mechanism: it inhibits the growth phase of microtubules without affecting the shortening phase. This disruption leads to the formation of non-productive tubulin aggregates, which ultimately causes cancer cells to arrest in the G2/M phase of the cell cycle and undergo apoptosis (programmed cell death).
This mechanism is distinct from other tubulin-targeting chemotherapy agents such as taxanes (paclitaxel, docetaxel) and vinca alkaloids (vincristine, vinblastine). While taxanes stabilize microtubules and vinca alkaloids inhibit microtubule assembly, eribulin specifically targets the growing ends of microtubules, making it effective even in cancers that have developed resistance to other chemotherapy drugs.
Approved Indications
Locally advanced or metastatic breast cancer: Eribulin is approved for the treatment of adult patients with locally advanced or metastatic breast cancer who have previously received at least one chemotherapy regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane, unless patients were not suitable for these treatments. Clinical trials have demonstrated that eribulin can extend overall survival compared with other treatment options in this setting, as shown in the pivotal EMBRACE trial (Cortes et al., The Lancet, 2011).
Advanced or metastatic liposarcoma: Eribulin is also approved for the treatment of adult patients with unresectable (inoperable) liposarcoma who have received prior anthracycline-containing therapy. Liposarcoma is a rare type of soft tissue sarcoma that develops in fat tissue. The approval in this indication was based on the Study 309 trial, which showed a significant improvement in overall survival compared to dacarbazine in patients with advanced liposarcoma (Schoffski et al., The Lancet, 2016).
It is important to note that eribulin is only administered in hospital settings or specialized cancer treatment centres under the supervision of a qualified oncologist who is experienced in the use of cytotoxic chemotherapy. The drug is not intended for self-administration and is never taken at home by patients.
What Should You Know Before Taking Eribulin Advanz Pharma?
Contraindications
Eribulin Advanz Pharma must not be used in the following situations:
- Hypersensitivity: If you are allergic to eribulin mesilate or any of the other ingredients in this medicine (including ethanol and water for injections)
- Breastfeeding: Eribulin must not be used during breastfeeding due to the potential risk of serious adverse effects in the nursing infant. Breastfeeding should be discontinued during treatment and should not be resumed after completion of therapy without medical advice
Warnings and Precautions
Before starting treatment with eribulin, inform your oncologist or specialist nurse if any of the following conditions apply to you:
- Liver problems: Patients with hepatic impairment may require dose adjustments. Liver function tests are routinely performed before and during treatment. Impaired liver function can increase eribulin blood levels, leading to a higher risk of side effects including severe neutropenia
- Fever or active infection: Treatment may need to be postponed if you have an active infection, as eribulin suppresses the immune system (neutropenia), which could worsen an existing infection
- Peripheral neuropathy: If you already experience numbness, tingling, prickling sensations, sensitivity to touch, or muscle weakness, tell your doctor. Eribulin can cause or worsen peripheral neuropathy, and the dose may need to be reduced or treatment discontinued if symptoms become severe
- Heart conditions: Eribulin may cause QT prolongation (a change in the heart's electrical activity). Patients with pre-existing heart rhythm disorders, congestive heart failure, slow heart rate (bradycardia), or those taking medications that affect heart rhythm require careful monitoring with regular ECG assessments
If any of the above conditions apply to you, your oncologist may decide to delay treatment, reduce the dose, or discontinue eribulin altogether. Never withhold this information from your healthcare team, as dose adjustments can significantly reduce the risk of serious adverse effects.
Use in Children and Adolescents
Eribulin Advanz Pharma is not recommended for use in children and adolescents aged 0 to 18 years. Clinical studies have shown that eribulin does not provide therapeutic benefit in paediatric solid tumours, and the safety profile in this age group has not been adequately established. The European Medicines Agency (EMA) has waived the requirement for studies in the paediatric population for the approved indications.
Pregnancy and Breastfeeding
Eribulin may cause serious harm to an unborn child based on preclinical data and its mechanism of action. Therefore, it should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the risks to the foetus, and only after careful discussion with the treating oncologist.
Women of childbearing potential must use effective contraception during treatment with eribulin and for at least 3 months after the last dose. If you become pregnant during treatment, inform your oncologist immediately.
Male fertility: Eribulin may cause permanent infertility in men. Male patients should discuss fertility preservation options (such as sperm banking) with their doctor before starting treatment. Men should use effective contraception during treatment and for at least 3 months after the last dose.
Breastfeeding is contraindicated during treatment with eribulin due to the potential for serious adverse reactions in the breastfed infant. It is not known whether eribulin or its metabolites are excreted in human breast milk.
Driving and Operating Machinery
Eribulin can cause side effects such as fatigue (very common, affecting more than 1 in 10 patients) and dizziness (common, affecting up to 1 in 10 patients). If you experience these symptoms, you should not drive or operate machinery until the effects have resolved. You are responsible for assessing your own fitness to perform tasks requiring alertness and coordination.
Eribulin Advanz Pharma contains small amounts of ethanol (alcohol), less than 100 mg per vial. This quantity is unlikely to cause any noticeable effects in most patients.
How Does Eribulin Advanz Pharma Interact with Other Drugs?
Before receiving eribulin, you must tell your oncologist about all medicines you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medications, herbal products, and dietary supplements. Although eribulin is primarily eliminated by biliary excretion and does not undergo extensive metabolism by cytochrome P450 enzymes, some interactions may still be clinically relevant.
Eribulin is not a significant inhibitor or inducer of CYP3A4 at clinically relevant concentrations. However, studies have shown that it is a substrate of P-glycoprotein (P-gp). Co-administration with P-gp inhibitors such as ketoconazole or ciclosporin did not result in clinically meaningful changes in eribulin exposure, so no dose adjustments are routinely required for P-gp interactions.
Interactions Requiring Caution
| Drug / Drug Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| QT-prolonging agents (e.g., amiodarone, sotalol, ondansetron, haloperidol) | Additive QT prolongation | High | ECG monitoring recommended; avoid combination if possible |
| Anti-arrhythmic drugs (Class Ia and III) | Additive QT prolongation, arrhythmia risk | High | Close cardiac monitoring; specialist cardiology review advised |
| Electrolyte-depleting drugs (loop diuretics, thiazides) | Enhanced risk of QT prolongation via hypokalaemia/hypomagnesaemia | Moderate | Monitor and correct electrolyte levels before each cycle |
| Live vaccines | Risk of generalised infection due to immunosuppression | High | Avoid live vaccines during and for a period after treatment |
| Anticoagulants (warfarin, heparin) | Altered coagulation due to thrombocytopenia risk | Moderate | Monitor INR and platelet counts closely |
The above list is not exhaustive. Always provide your oncologist with a complete list of all medications and supplements you are using. Drug interaction profiles may be updated as new evidence becomes available. Your pharmacist can also help identify potential interactions before starting a new medication.
What Is the Correct Dosage of Eribulin Advanz Pharma?
Eribulin Advanz Pharma is always administered by a qualified healthcare professional in a hospital or cancer treatment centre. You will never need to prepare or inject this medicine yourself. The dose is carefully calculated for each individual patient based on their body surface area (BSA), which is determined from height and weight measurements.
Adults
Standard Dosing Regimen
Dose: 1.23 mg/m² (equivalent to 1.4 mg/m² eribulin mesilate)
Route: Intravenous injection over 2 to 5 minutes
Schedule: Days 1 and 8 of each 21-day cycle
Duration: Treatment continues until disease progression or unacceptable toxicity
Before each administration, your oncologist will review your blood test results, particularly your neutrophil count (a type of white blood cell) and liver function values. Treatment may be delayed if:
- Your absolute neutrophil count (ANC) is below 1.0 x 10&sup9;/L on the planned treatment day
- Your platelet count is below 75 x 10&sup9;/L
- You have developed Grade 3 or 4 non-haematological toxicities
Following recovery, your oncologist may decide to resume treatment at a reduced dose. The standard dose reduction schedule proceeds from 1.23 mg/m² to 0.97 mg/m², and if further reduction is needed, to 0.62 mg/m². If a dose below 0.62 mg/m² would be required, discontinuation of eribulin is generally recommended.
| Dose Level | Dose (mg/m²) | Indication for Reduction |
|---|---|---|
| Standard dose | 1.23 mg/m² | Initial starting dose |
| First reduction | 0.97 mg/m² | Grade 3/4 neutropenia, febrile neutropenia, or Grade 3 non-haematological toxicity |
| Second reduction | 0.62 mg/m² | Recurrence of toxicity at first reduced dose |
Hepatic Impairment
Patients with liver impairment may require dose reductions. For mild hepatic impairment (Child-Pugh A), a starting dose of 0.97 mg/m² is recommended. For moderate hepatic impairment (Child-Pugh B), the recommended starting dose is 0.62 mg/m². Eribulin has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is generally not recommended.
Renal Impairment
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). For patients with moderate or severe renal impairment, limited data are available, and caution is advised. Haemodialysis does not significantly remove eribulin from the body.
Children
Eribulin is not approved for use in children and adolescents under 18 years of age. Clinical efficacy has not been established in the paediatric population for any indication.
Elderly Patients
No specific dose adjustment is required based on age alone. However, elderly patients (≥ 65 years) may be more susceptible to certain side effects, particularly neutropenia and peripheral neuropathy. Close monitoring and individualized dose adjustments based on tolerability are recommended.
Missed Dose
Since eribulin is administered by healthcare professionals in a clinical setting, missed doses are managed by your treatment team. If a scheduled dose is missed or delayed (for example, due to low blood counts), your oncologist will determine the appropriate time to resume treatment. The treatment cycle may be extended as needed, but the dose should not be doubled to make up for a missed administration.
Overdose
Overdose with eribulin in a clinical setting is uncommon due to the controlled administration process. However, if an overdose occurs, it would be expected to cause severe neutropenia (dangerously low white blood cell count) with an increased risk of infection, as well as intensified gastrointestinal side effects (nausea, vomiting, diarrhoea). There is no specific antidote for eribulin overdose. Treatment is supportive, with intensive monitoring of blood counts and administration of granulocyte colony-stimulating factor (G-CSF) as clinically indicated.
After each eribulin injection, a saline flush is recommended to ensure complete delivery of the dose and to prevent any residual drug from remaining in the intravenous line. The injection site should be monitored for signs of extravasation (leaking of the drug outside the vein), as this can cause local tissue damage.
What Are the Side Effects of Eribulin Advanz Pharma?
The side effects of eribulin have been thoroughly characterised in clinical trials involving thousands of patients. Understanding the frequency and nature of potential side effects allows you and your healthcare team to monitor for them proactively and take action when needed. Side effects are categorised below by their frequency of occurrence.
Stop treatment and contact your oncologist or seek emergency medical care immediately if you experience any of the following serious symptoms:
- Signs of sepsis: Fever with rapid heartbeat, fast shallow breathing, cold/pale/clammy skin, and/or confusion. Sepsis is an uncommon (up to 1 in 100 patients) but potentially life-threatening reaction to infection
- Signs of severe allergic reaction: Difficulty breathing, swelling of the face, mouth, tongue, or throat. This is uncommon (up to 1 in 100 patients)
- Signs of Stevens-Johnson syndrome/toxic epidermal necrolysis: Severe skin rash with blistering of the skin, mouth, eyes, and genitals. The frequency of this condition is not known, but it can be life-threatening
Side Effect Frequency Overview
Very Common
- Decreased white blood cell count (neutropenia, leukopenia)
- Decreased red blood cell count (anaemia)
- Fatigue or weakness (asthenia)
- Nausea and vomiting
- Constipation and diarrhoea
- Peripheral neuropathy (numbness, tingling, prickling sensations)
- Fever (pyrexia)
- Decreased appetite and weight loss
- Shortness of breath (dyspnoea) and cough
- Joint, muscle, and back pain
- Headache
- Hair loss (alopecia)
Common
- Decreased platelet count (thrombocytopenia) – may lead to easy bruising and prolonged bleeding
- Febrile neutropenia, pneumonia, chills
- Rapid heart rate (tachycardia), hot flushes
- Vertigo, dizziness
- Increased tear production, conjunctivitis, nosebleeds
- Dehydration, dry mouth, oral herpes, oral thrush, indigestion, abdominal pain or bloating
- Soft tissue swelling, pain (chest, back, bone), muscle cramps or weakness
- Urinary tract infections, painful urination
- Sore throat, runny nose, flu-like symptoms
- Abnormal liver function tests, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
- Insomnia, depression, altered taste
- Skin rash, itching, nail problems, dry or red skin
- Excessive sweating (including night sweats)
- Tinnitus (ringing in the ears)
- Pulmonary embolism (blood clots in the lungs)
- Shingles (herpes zoster)
- Swelling of the skin, numbness in hands and feet
Uncommon
- Blood clots (deep vein thrombosis)
- Hepatotoxicity (abnormal liver function tests indicating liver damage)
- Kidney failure, blood or protein in urine
- Interstitial lung disease (widespread lung inflammation that may cause scarring)
- Pancreatitis (inflammation of the pancreas)
- Mouth ulcers (stomatitis)
Rare
- Disseminated intravascular coagulation (DIC) – a serious blood clotting disorder leading to widespread clot formation and internal bleeding
Managing Side Effects
Your oncology team has extensive experience in managing the side effects of chemotherapy. Regular blood tests are performed before each treatment cycle to monitor for neutropenia and other blood count abnormalities. If significant neutropenia develops, your doctor may prescribe granulocyte colony-stimulating factor (G-CSF) injections to boost white blood cell production, delay treatment until counts recover, or reduce the dose.
Peripheral neuropathy is a cumulative side effect that may worsen with continued treatment. Report any new or worsening symptoms of numbness, tingling, or weakness in your hands or feet promptly. Early dose adjustment can help prevent permanent nerve damage. In some cases, neuropathy symptoms may improve partially or fully after treatment is stopped, although resolution can take several months.
Nausea and vomiting can usually be managed effectively with anti-emetic medications prescribed before and after each treatment cycle. Adequate hydration and small, frequent meals are also recommended. If you experience severe or persistent gastrointestinal symptoms, contact your healthcare team, as intravenous fluids may be needed to prevent dehydration.
It is important to report suspected side effects after the medicine has been authorised. This allows continuous monitoring of the benefit-risk balance. Healthcare professionals and patients can report suspected adverse reactions to their national medicines regulatory authority (e.g., the EMA in the EU, the FDA in the US, or the MHRA in the UK).
How Should You Store Eribulin Advanz Pharma?
As a hospital-administered medicine, the storage of Eribulin Advanz Pharma is managed by the pharmacy and healthcare professionals at your treatment centre. Patients do not typically handle or store this medicine at home. However, it is useful to understand the storage requirements:
- Unopened vials: No special storage conditions are required. Store at room temperature. Keep out of the sight and reach of children
- Expiry date: Do not use this medicine after the expiry date stated on the carton and vial label after "EXP." The expiry date refers to the last day of that month
- Diluted solution for infusion: Should be used immediately. If not used immediately, it may be stored at 25°C under normal room lighting for up to 48 hours, or at 2-8°C for up to 72 hours
- Undiluted solution in a syringe: May be stored at 25°C under normal room lighting for up to 48 hours, or at 2-8°C for up to 72 hours
- Disposal: Any unused medicine or waste material must be disposed of in accordance with local requirements for cytotoxic waste. Do not dispose of via wastewater or household waste
What Does Eribulin Advanz Pharma Contain?
Active Substance
The active substance is eribulin (as eribulin mesilate). Each millilitre of solution contains eribulin mesilate equivalent to 0.44 mg eribulin. Each 2 ml vial therefore contains eribulin mesilate equivalent to 0.88 mg eribulin. Eribulin mesilate is a synthetic analogue of halichondrin B, a naturally occurring compound isolated from the marine sponge Halichondria okadai.
Inactive Ingredients (Excipients)
- Anhydrous ethanol (alcohol)
- Water for injections
- Hydrochloric acid (for pH adjustment, in very small amounts)
- Sodium hydroxide (for pH adjustment, in very small amounts)
Appearance and Packaging
Eribulin Advanz Pharma is a clear, colourless solution free from visible particles. It is supplied in type I glass vials containing 2 ml of solution. Each carton contains 1 vial. The solution is ready for use and does not require reconstitution, although it may be diluted with 0.9% sodium chloride solution for infusion if needed.
Marketing Authorisation Holder
ADVANZ PHARMA Limited, Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland. This product is manufactured by KeVaRo Group Ltd (Sofia, Bulgaria) or Pharmadox Healthcare Limited (Paola, Malta).
Frequently Asked Questions About Eribulin Advanz Pharma
Eribulin Advanz Pharma is used to treat locally advanced or metastatic breast cancer in adults when at least one prior chemotherapy regimen (including an anthracycline and a taxane) has been tried but is no longer effective. It is also approved for advanced or metastatic liposarcoma, a type of soft tissue sarcoma arising from fat tissue, when previous treatments including anthracycline-containing therapy have failed.
Eribulin has a unique mechanism of action compared to other microtubule-targeting agents. While taxanes (paclitaxel, docetaxel) stabilize microtubules and vinca alkaloids (vincristine) prevent microtubule assembly, eribulin specifically inhibits the growth phase of microtubules without affecting the shortening phase. This distinct mechanism means eribulin can be effective in cancers that have become resistant to other chemotherapy drugs. It is also notable for having demonstrated an overall survival benefit in clinical trials for metastatic breast cancer.
There is no fixed duration for eribulin treatment. Treatment continues for as long as it is providing benefit (controlling the cancer) and the side effects remain manageable. Each treatment cycle is 21 days, with injections on days 1 and 8. Your oncologist will regularly assess your response to treatment through imaging scans and blood tests to determine whether to continue, modify, or stop treatment.
Yes, hair loss (alopecia) is a very common side effect of eribulin, affecting more than 1 in 10 patients. Hair loss typically begins within the first few treatment cycles and may be partial or complete. In most cases, hair begins to regrow after treatment is completed, although the regrowth may initially differ in colour or texture. Scalp cooling caps may help reduce hair loss in some patients, though their effectiveness with eribulin specifically has not been extensively studied.
Eribulin Advanz Pharma and Halaven both contain the same active substance (eribulin mesilate) at the same concentration (0.44 mg/ml). Halaven was the original brand-name product developed by Eisai, while Eribulin Advanz Pharma is marketed by ADVANZ PHARMA Limited. They are therapeutically equivalent, meaning they work in the same way and are used for the same conditions at the same doses. Other available eribulin products include Eribulin STADA, Eribulin EVER Pharma, Eribulin Glenmark, and Eribulin Baxter.
While the medicine itself contains a very small amount of ethanol (less than 100 mg per vial), alcohol consumption during chemotherapy is generally not recommended. Alcohol can worsen common side effects such as nausea, fatigue, and dehydration. It may also affect liver function, which is important for the clearance of eribulin. Discuss alcohol consumption with your oncologist, who can provide personalised advice based on your overall health and treatment plan.
References
This article is based on the following peer-reviewed sources and authoritative medical guidelines:
- European Medicines Agency (EMA). Eribulin – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu. Accessed December 2025.
- Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011;377(9769):914-923. doi:10.1016/S0140-6736(11)60070-6
- Schoffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016;387(10028):1629-1637. doi:10.1016/S0140-6736(15)01283-0
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2.2025. Available at: www.nccn.org.
- European Society for Medical Oncology (ESMO). Metastatic breast cancer: ESMO Clinical Practice Guidelines. Annals of Oncology. 2024;35(2):159-182.
- British National Formulary (BNF). Eribulin. Available at: bnf.nice.org.uk. Accessed December 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- U.S. Food and Drug Administration (FDA). HALAVEN (eribulin mesylate) Prescribing Information. Available at: www.accessdata.fda.gov.
Medical Editorial Team
This article has been written by the iMedic Medical Editorial Team and reviewed by independent medical specialists in oncology and clinical pharmacology. All content follows the GRADE evidence framework and adheres to international medical guidelines from the EMA, FDA, ESMO, and NCCN.
iMedic Medical Editorial Team – specialists with backgrounds in oncology, pharmacology, and evidence-based medicine. All medical claims are verified against peer-reviewed sources and current clinical practice guidelines.
iMedic Medical Review Board – an independent panel of board-certified oncologists and clinical pharmacists who review all medicine-related content for accuracy, completeness, and clinical relevance.
Editorial Standards: iMedic maintains strict editorial independence. We have no commercial funding, pharmaceutical company sponsorship, or advertising. All content is based on the highest available level of evidence (Level 1A where possible) and is regularly updated when new evidence or guideline changes emerge.