Eribulin STADA Arzneimittel AG
Eribulin mesilate — Antineoplastic agent (microtubule dynamics inhibitor)
Eribulin STADA Arzneimittel AG (eribulin mesilate) is a prescription chemotherapy medication administered as an intravenous injection. It is approved for the treatment of locally advanced or metastatic breast cancer in adults who have progressed after at least one chemotherapy regimen, and for unresectable liposarcoma in adults previously treated with anthracycline-containing therapy. Eribulin works by inhibiting microtubule dynamics, preventing cancer cells from dividing. This article provides comprehensive, evidence-based information about eribulin's uses, dosage, side effects, drug interactions, and storage requirements.
Quick Facts
Key Takeaways
- Eribulin STADA is a chemotherapy drug used for metastatic breast cancer and unresectable liposarcoma in adults who have received prior treatment.
- It is administered intravenously by a healthcare professional on days 1 and 8 of a 21-day cycle, and should never be self-administered.
- The most common serious side effect is neutropenia (severely low white blood cells), requiring blood count monitoring before every dose.
- Peripheral neuropathy (numbness and tingling) affects about 35% of patients and may require dose adjustments.
- Eribulin is contraindicated during pregnancy and breastfeeding due to the risk of harm to the developing baby.
What Is Eribulin STADA and What Is It Used For?
Eribulin mesilate is a synthetic analogue of halichondrin B, a substance originally isolated from the marine sponge Halichondria okadai. It belongs to the class of antineoplastic agents that target microtubule dynamics. Unlike taxanes (such as paclitaxel or docetaxel) which stabilize microtubules, eribulin has a unique mechanism: it inhibits the growth phase of microtubules without significantly affecting the shortening phase. This leads to the formation of non-productive tubulin aggregates, ultimately causing mitotic catastrophe and apoptotic cell death in rapidly dividing cancer cells.
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have approved eribulin for two primary indications. The first is locally advanced or metastatic breast cancer in adult patients who have progressed after at least one chemotherapy regimen for advanced disease, with prior therapy typically including an anthracycline and a taxane unless patients were not suitable for these treatments. The second approved indication is unresectable liposarcoma in adult patients who have received prior anthracycline-containing therapy for advanced or metastatic disease.
Eribulin STADA Arzneimittel AG is a generic formulation of eribulin mesilate, containing the same active substance and concentration (0.44 mg/ml) as the original reference product Halaven (manufactured by Eisai). As a generic medication, it has been assessed by regulatory authorities to demonstrate bioequivalence with the reference product, meaning it provides the same therapeutic effect and safety profile. The availability of generic eribulin contributes to broader patient access to this important chemotherapy agent.
Clinical trials, including the landmark EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), demonstrated that eribulin significantly improved overall survival in patients with heavily pretreated metastatic breast cancer compared to treatment of physician's choice. The median overall survival was 13.1 months with eribulin versus 10.6 months with comparator treatments. For liposarcoma, the pivotal phase III study (Study 309) demonstrated a significant improvement in overall survival with eribulin compared to dacarbazine, with median overall survival of 15.6 months versus 8.4 months.
What Should You Know Before Taking Eribulin STADA?
Eribulin STADA is a potent cytotoxic agent and must only be prescribed and administered under the supervision of a physician experienced in the use of anticancer chemotherapy. Before initiating treatment, your healthcare team will conduct a thorough assessment to determine whether eribulin is appropriate for your clinical situation. This evaluation includes a complete medical history, physical examination, laboratory tests, and cardiac assessment.
Contraindications
Eribulin should not be used in the following circumstances:
- Hypersensitivity: Known allergy to eribulin mesilate or any of the excipients in the formulation.
- Breastfeeding: Eribulin must not be used during breastfeeding. Breastfeeding should be discontinued during treatment and for at least 3 months after the last dose.
- Severe neutropenia: Absolute neutrophil count (ANC) below 1.5 x 109/L prior to treatment initiation or retreatment.
- Severe hepatic impairment: Patients with Child-Pugh class C liver dysfunction should not receive eribulin.
Warnings and Precautions
Several important warnings and precautions should be considered before and during eribulin treatment. The most critical concern is myelosuppression, particularly neutropenia. Complete blood counts must be performed before administration of each dose of eribulin. Febrile neutropenia has been reported in approximately 5% of patients treated with eribulin, and fatal outcomes from neutropenic sepsis have occurred. If severe neutropenia (ANC below 0.5 x 109/L lasting more than 7 days) develops, treatment must be delayed and the dose may need to be reduced for subsequent cycles.
Peripheral neuropathy is another significant concern. Patients should be closely monitored for signs of peripheral motor and sensory neuropathy, including numbness, tingling, burning sensations, or weakness in the extremities. Patients with pre-existing neuropathy (grade 1 or 2) may be at increased risk of worsening symptoms. If grade 3 or 4 peripheral neuropathy develops, eribulin must be delayed until resolution to grade 2 or less, and the dose should be reduced upon resumption.
QT prolongation has been observed with eribulin treatment. An independent QT study demonstrated that eribulin can prolong the QTc interval by approximately 11 milliseconds on day 8. Eribulin should be used with caution in patients with congestive heart failure, bradyarrhythmias, or electrolyte imbalances (particularly hypokalemia and hypomagnesemia), and in patients taking concomitant medications known to prolong the QT interval. Electrolyte levels should be monitored and corrected before initiating treatment, and an electrocardiogram (ECG) should be performed at baseline.
Pregnancy and Breastfeeding
Eribulin is classified as a substance with known teratogenic and embryotoxic potential. Animal studies have demonstrated developmental abnormalities and embryo-fetal death at doses well below those used in clinical practice. Therefore, eribulin is contraindicated during pregnancy and should only be administered to women of childbearing potential who are using highly effective contraception during treatment and for at least 3 months after the last dose.
Male patients with female partners of childbearing potential should also use effective contraception during treatment and for at least 3 months after the last dose. Eribulin may impair male fertility, and men may consider sperm preservation before treatment.
It is not known whether eribulin is excreted in human breast milk. Given the potential for serious adverse reactions in nursing infants, breastfeeding must be discontinued during treatment and for at least 3 months after the final dose. Patients should discuss family planning considerations with their oncologist before starting treatment.
How Does Eribulin STADA Interact with Other Drugs?
Understanding potential drug interactions is essential for safe eribulin therapy. While eribulin has fewer drug interactions than many other antineoplastic agents, several clinically significant interactions should be considered. Your oncologist and pharmacist will review all your current medications before each treatment cycle to identify and manage potential interactions.
Eribulin is metabolized to a small extent by cytochrome P450 3A4 (CYP3A4). In vitro studies have shown that eribulin does not significantly inhibit or induce the major CYP enzymes at clinically relevant concentrations. However, co-administration with strong CYP3A4 inhibitors may theoretically increase eribulin plasma concentrations, and close monitoring is recommended in such cases.
Major Interactions
| Interacting Drug | Mechanism | Clinical Effect | Recommendation |
|---|---|---|---|
| QT-prolonging agents (e.g. sotalol, amiodarone, ondansetron) | Additive QT prolongation | Increased risk of cardiac arrhythmias (torsades de pointes) | ECG monitoring; correct electrolytes; use alternative antiemetics where possible |
| Live vaccines (e.g. BCG, yellow fever, MMR) | Immunosuppression from eribulin | Risk of disseminated vaccine infection; reduced vaccine efficacy | Avoid live vaccines during treatment and for at least 3 months after |
| Other myelosuppressive agents | Additive bone marrow suppression | Increased risk of severe neutropenia, thrombocytopenia, and anaemia | Enhanced blood count monitoring; consider dose adjustments |
| Anticoagulants (e.g. warfarin) | Altered hepatic metabolism and thrombocytopenia risk | Increased bleeding risk | Monitor INR closely; adjust anticoagulant dose as needed |
Minor Interactions
| Interacting Drug | Mechanism | Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole) | Potential increase in eribulin exposure | Monitor for increased toxicity; clinical studies showed no significant interaction with ketoconazole |
| P-glycoprotein (P-gp) substrates | Eribulin is a weak P-gp inhibitor | Monitor narrow therapeutic index P-gp substrates (e.g. digoxin, dabigatran) |
| Inactivated vaccines (e.g. influenza, COVID-19) | Reduced immune response | May be given; efficacy may be reduced; timing between chemotherapy cycles is optimal |
Always inform your oncology team about all medications you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. Some herbal supplements, particularly St John's wort (Hypericum perforatum), can affect the metabolism of chemotherapy drugs and should be avoided during treatment. Your pharmacist can provide a comprehensive medication review to identify any potential interactions.
What Is the Correct Dosage of Eribulin STADA?
Eribulin must be administered in a clinical setting by or under the direct supervision of a healthcare professional experienced in the use of cytotoxic agents. The dose is calculated based on the patient's body surface area (BSA), which is determined using the patient's height and weight. Accurate dosing is critical for maintaining the balance between therapeutic efficacy and manageable toxicity.
Adults
Standard Dosing for Adults
Dose: 1.23 mg/m2 body surface area, administered intravenously over 2 to 5 minutes.
Schedule: Days 1 and 8 of each 21-day cycle.
Duration: Treatment continues until disease progression or unacceptable toxicity.
Note: The dose of 1.23 mg/m2 eribulin (expressed as the free base) corresponds to 1.4 mg/m2 of eribulin mesilate salt. Prescribing information should always be checked for the specific formulation being used.
| Body Surface Area (m2) | Dose per Administration (mg) | Volume of 0.44 mg/ml Solution (ml) |
|---|---|---|
| 1.4 | 1.72 mg | 3.9 ml |
| 1.6 | 1.97 mg | 4.5 ml |
| 1.8 | 2.21 mg | 5.0 ml |
| 2.0 | 2.46 mg | 5.6 ml |
| 2.2 | 2.71 mg | 6.2 ml |
Dose Reductions for Toxicity
If patients experience significant toxicities, the dose may be reduced according to predefined criteria. The recommended dose reduction levels are:
| Dose Level | Eribulin Dose (mg/m2) | Indication |
|---|---|---|
| Standard dose | 1.23 mg/m2 | Starting dose for all patients with normal organ function |
| First reduction | 0.97 mg/m2 | After grade 3/4 neutropenia, grade 3/4 neuropathy, or other significant toxicity |
| Second reduction | 0.62 mg/m2 | After recurrence of the same toxicity at first reduction level |
| Discontinuation | N/A | If toxicity recurs at 0.62 mg/m2, treatment should be discontinued |
Children
Eribulin is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of eribulin in paediatric patients have not been established. Clinical trials in paediatric populations have not demonstrated sufficient evidence to support its use in this age group. Treatment of paediatric cancers should follow established guidelines from organisations such as the Children's Oncology Group (COG) and the European Society for Paediatric Oncology (SIOPE).
Elderly Patients
No specific dose adjustment is required for elderly patients solely on the basis of age. However, elderly patients may be more susceptible to certain adverse effects, particularly neutropenia, fatigue, and peripheral neuropathy. Close monitoring of blood counts and neurological function is recommended. Renal function should be assessed, as age-related decline in renal function may affect drug clearance. In clinical trials, patients over 65 years showed similar response rates but higher incidence of grade 3/4 neutropenia compared to younger patients.
Missed Dose
If a scheduled dose is delayed or missed due to adverse effects or other reasons, the treating oncologist will determine the appropriate action based on the clinical situation. Generally, if the day 8 dose is missed or delayed beyond day 8 of the cycle, it is omitted entirely for that cycle. The next cycle should begin on day 1 as scheduled, provided blood counts and clinical status are acceptable. Doses should never be doubled to compensate for a missed administration.
Overdose
There is no specific antidote for eribulin overdose. In the event of accidental overdose, the patient should be closely monitored with frequent blood count assessments. Supportive care, including treatment of neutropenia and any other toxicities, should be initiated as clinically indicated. Based on the mechanism of action, anticipated effects of overdose include severe neutropenia, peripheral neuropathy, and gastrointestinal toxicity. The long terminal half-life of eribulin (approximately 40 hours) means that adverse effects may be prolonged. Healthcare providers should contact their local poison control centre for additional guidance.
What Are the Side Effects of Eribulin STADA?
Like all chemotherapy medications, eribulin can cause side effects. Not everyone will experience all of these effects, and their severity can vary significantly between patients. Understanding the potential side effects and their frequency helps patients and caregivers recognize symptoms early and seek appropriate medical attention when necessary.
The side effects listed below are categorised according to their frequency of occurrence in clinical trials. The frequency categories follow standard medical classification: very common (affects more than 1 in 10 patients), common (1 in 10 to 1 in 100), uncommon (1 in 100 to 1 in 1,000), and rare (less than 1 in 1,000). Your oncology team will monitor you closely for these effects and adjust treatment as needed.
Very Common Side Effects
Affects more than 1 in 10 patients (>10%)
- Neutropenia — Low white blood cell count (54%); can increase infection risk
- Leucopenia — Reduction in total white blood cells
- Anaemia — Low red blood cell count causing fatigue and weakness
- Fatigue/Asthenia — Tiredness and lack of energy (54%)
- Nausea — Feeling of sickness (35%)
- Alopecia — Hair loss (45%)
- Constipation — Difficulty with bowel movements (25%)
- Peripheral neuropathy — Numbness, tingling in hands/feet (35%)
- Arthralgia/Myalgia — Joint and muscle pain
- Decreased appetite — Reduced desire to eat
- Weight loss — Unintentional decrease in body weight
Common Side Effects
Affects 1 in 10 to 1 in 100 patients (1–10%)
- Febrile neutropenia — Neutropenia with fever (5%); requires urgent medical attention
- Thrombocytopenia — Low platelet count
- Vomiting — Being sick
- Diarrhoea — Loose or frequent bowel movements
- Stomatitis — Mouth sores and inflammation
- Abdominal pain — Pain in the stomach area
- Headache — Pain in the head
- Dizziness — Feeling lightheaded or unsteady
- Dyspnoea — Shortness of breath
- Cough — Persistent cough
- Pyrexia — Elevated body temperature
- Insomnia — Difficulty sleeping
- Dysgeusia — Altered taste sensation
- Urinary tract infection
- Back pain
- Peripheral oedema — Swelling in hands, feet, or ankles
Uncommon Side Effects
Affects 1 in 100 to 1 in 1,000 patients (0.1–1%)
- Pneumonia — Lung infection
- Sepsis — Severe systemic infection (potentially life-threatening)
- Hepatotoxicity — Liver damage with elevated enzymes
- Interstitial lung disease — Inflammatory lung condition
- Pancreatitis — Inflammation of the pancreas
- Deep vein thrombosis — Blood clot in deep veins
- Pulmonary embolism — Blood clot in the lungs
Rare Side Effects
Affects less than 1 in 1,000 patients (<0.1%)
- Stevens-Johnson syndrome — Serious skin reaction
- Toxic epidermal necrolysis — Severe skin blistering
- QT prolongation/Torsades de pointes — Serious cardiac rhythm disturbance
- Disseminated intravascular coagulation — Widespread clotting disorder
It is important to report all side effects to your oncology team, even those that seem minor. Side effect reporting helps healthcare providers optimize your treatment plan and contributes to ongoing pharmacovigilance. In many countries, patients can also report suspected side effects directly to their national medicines regulatory authority (e.g. the Yellow Card scheme in the UK, MedWatch in the USA, or the EudraVigilance system in the EU).
How Should You Store Eribulin STADA?
Proper storage of eribulin is essential to maintain its stability and efficacy. As a hospital-administered medication, storage is primarily the responsibility of pharmacy and nursing staff, but patients and caregivers should be aware of proper handling procedures.
Eribulin STADA solution for injection (0.44 mg/ml) should be stored at temperatures below 25°C in the original carton to protect the product from light. The solution must not be frozen. If stored according to these conditions, the product remains stable until the expiry date printed on the packaging.
Once the vial is opened or punctured, eribulin should be used immediately. If dilution is required, the diluted solution should be used within 24 hours when stored at 2°C to 8°C (refrigerated) or within 4 hours at room temperature (below 25°C). From a microbiological perspective, the diluted product should be used immediately to minimise the risk of microbial contamination.
The product is a clear, colourless aqueous solution supplied in glass vials. Before use, the solution should be inspected visually for any particles or discolouration. If any particulate matter or colour change is observed, the vial should not be used. As with all cytotoxic medications, any unused product or waste material should be disposed of in accordance with local regulations for hazardous pharmaceutical waste. Healthcare workers should follow standard safety precautions for handling cytotoxic agents, including the use of protective gloves and clothing.
What Does Eribulin STADA Contain?
Eribulin STADA is supplied as a ready-to-use solution for intravenous injection. Understanding the composition is important for identifying potential allergies or intolerances to any of the ingredients.
Active Substance
The active substance is eribulin mesilate. Each millilitre of solution contains 0.44 mg of eribulin (equivalent to 0.50 mg of eribulin mesilate). Each 2 ml vial contains 0.88 mg of eribulin (equivalent to 1.0 mg of eribulin mesilate). The mesilate (mesylate) salt form is used to enhance the solubility and stability of the active compound.
Excipients (Inactive Ingredients)
- Ethanol (anhydrous) — Used as a co-solvent to maintain eribulin in solution. The ethanol content per maximum dose is small and not clinically significant for most patients.
- Water for injections — The primary solvent for the formulation.
- Hydrochloric acid (dilute) — Used for pH adjustment to ensure stability and compatibility with intravenous administration.
- Sodium hydroxide — May be used for pH adjustment.
The solution is clear and colourless with a pH of approximately 6.5. It does not contain any preservatives, and therefore each vial is intended for single use only. Any unused portion should be discarded according to local regulations for cytotoxic waste disposal.
Frequently Asked Questions About Eribulin STADA
Eribulin is used to treat locally advanced or metastatic breast cancer in adults who have progressed after at least one prior chemotherapy regimen for advanced disease. It is also approved for unresectable liposarcoma in adults who have received prior anthracycline-containing therapy. Eribulin works by inhibiting microtubule dynamics, preventing cancer cells from dividing and ultimately leading to their death.
Eribulin is administered as an intravenous injection over 2 to 5 minutes on days 1 and 8 of a 21-day treatment cycle. It must be given by or under the supervision of a qualified healthcare professional experienced in chemotherapy. It cannot be taken at home or self-administered. Before each dose, blood tests are performed to ensure your blood counts are at safe levels.
The most common side effects include neutropenia (low white blood cell count, over 50% of patients), fatigue (54%), hair loss (45%), nausea (35%), peripheral neuropathy (numbness/tingling in hands and feet, 35%), and constipation (25%). Most side effects are manageable with supportive care. Severe neutropenia is the most concerning effect and requires blood count monitoring before every dose.
Yes, peripheral neuropathy is a common side effect of eribulin, affecting approximately 35% of patients. Symptoms include numbness, tingling, or burning sensations in the hands and feet. If you develop grade 3 or 4 neuropathy, treatment should be delayed until symptoms improve. Your oncologist may reduce the dose or discontinue treatment if neuropathy becomes severe or persistent. Patients with pre-existing neuropathy should discuss the increased risks with their doctor before starting treatment.
Eribulin STADA contains the same active substance (eribulin mesilate) at the same concentration (0.44 mg/ml) as Halaven, which was the original brand manufactured by Eisai. Eribulin STADA is a generic version produced by STADA Arzneimittel AG. Both products have undergone regulatory review to ensure they provide the same therapeutic efficacy and safety profile. The main difference is typically in pricing, with generic versions often being more affordable.
Some medications can interact with eribulin. Always inform your oncologist about all medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins. Particular caution is needed with QT-prolonging drugs, live vaccines (which must be avoided), and other myelosuppressive agents. Your healthcare team will review your medication list before each treatment cycle to identify and manage potential interactions.
References
- European Medicines Agency (EMA). Halaven (eribulin) — Summary of Product Characteristics. Last updated 2024. Available at: EMA Halaven EPAR.
- 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.
- U.S. Food and Drug Administration (FDA). Halaven (eribulin mesylate) — Prescribing Information. Available at: FDA Prescribing Information.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2.2025.
- 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. doi:10.1016/j.annonc.2020.09.010.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. 2023.
- Kaufman PA, Awada A, Twelves C, et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. Journal of Clinical Oncology. 2015;33(6):594-601. doi:10.1200/JCO.2013.52.4892.
- British National Formulary (BNF). Eribulin monograph. Available at: bnf.nice.org.uk.
- Dybdal-Hargreaves NF, Risinger AL, Mooberry SL. Eribulin mesylate: mechanism of action of a unique microtubule-targeting agent. Clinical Cancer Research. 2015;21(11):2445-2452. doi:10.1158/1078-0432.CCR-14-3252.
Medical Editorial Team
This article has been researched, written, and reviewed by the iMedic Medical Editorial Team, which includes specialists in oncology, clinical pharmacology, and evidence-based medicine.
Written by medical writers with expertise in oncology pharmacotherapy, using EMA and FDA approved prescribing information, peer-reviewed clinical trial data, and international treatment guidelines as primary sources.
Reviewed by board-certified oncologists and clinical pharmacologists on the iMedic Medical Review Board. All medical claims are verified against Level 1A evidence (systematic reviews and meta-analyses of randomized controlled trials).
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