eribulin
Halaven · ATC code L01XX41
Brand names: Halaven, Eribulin Accord, Eribulin Advanz Pharma, Eribulin Ever Pharma, Eribulin Tillomed, Eribulin Aqvida, Eribulin Beta, Eribulin Stada, Eribulin Zentiva, Erlinat
- Key facts
- Active substance
- eribulin
- ATC code
- L01XX41
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- HALAVEN 0.44 mg/ml solution for injection
- Marketing authorisation holder
- Eisai GmbH
- Information as of
- 2026-10-28
Key facts
Eribulin (Halaven) is a cytotoxic microtubule-dynamics inhibitor used for advanced breast cancer and unresectable liposarcoma.
What it is used for
- Adults with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapy regimen for advanced disease; prior therapy should have included an anthracycline and a taxane unless unsuitable.
- Adults with unresectable liposarcoma after prior anthracycline-containing therapy (unless unsuitable) for advanced or metastatic disease.
Dosing
- 1.23 mg/m² intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle (dose expressed as eribulin base).
- Delay the dose if ANC < 1 × 10⁹/l, platelets < 75 × 10⁹/l, or Grade 3 or 4 non-haematological toxicity.
- After specified toxicities, reduce to 0.97 mg/m², if they recur to 0.62 mg/m², then consider discontinuation; do not re-escalate.
- Hepatic impairment due to metastases: Child-Pugh A 0.97 mg/m², Child-Pugh B 0.62 mg/m²; Child-Pugh C not studied.
- With creatinine clearance <50 ml/min a dose reduction may be needed; consider antiemetic prophylaxis.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Breast-feeding.
Important warnings
- Dose-dependent myelosuppression, mainly neutropenia; blood counts before each dose. Start only if ANC ≥ 1.5 × 10⁹/l and platelets > 100 × 10⁹/l. Fatal febrile neutropenia and sepsis have been reported.
- Higher risk of severe neutropenia with ALT/AST >3 × ULN or bilirubin >1.5 × ULN.
- Monitor closely for peripheral neuropathy; severe neurotoxicity requires dose delay or reduction.
- QT prolongation (seen on Day 8): ECG monitoring in heart failure, bradyarrhythmias, QT-prolonging medicines or electrolyte abnormalities.
Side effects
- Most common: bone marrow suppression (neutropenia, leucopenia, anaemia, thrombocytopenia) with infections, and new or worsening peripheral neuropathy.
- Gastrointestinal: anorexia, nausea, vomiting, diarrhoea, constipation, stomatitis.
- Others: fatigue, alopecia, increased liver enzymes, sepsis, musculoskeletal pain; urinary tract infection (8.5%).
Interactions
- No interactions expected with CYP3A4 inhibitors or inducers (ketoconazole and rifampicin had no effect).
- QT-prolonging medicines (e.g. Class Ia and III antiarrhythmics): ECG monitoring.
Pregnancy and breastfeeding
- Use in pregnancy only if clearly necessary (teratogenic in rats). Highly effective contraception for 7 months after treatment in women and effective contraception for 4 months in men.
- Breast-feeding is contraindicated.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Eribulin Baxter · genericBaxter Holding B.V. · EMEA/H/C/006191
- HalavenEisai GmbH · EMEA/H/C/002084
- Mevlyq · genericYES Pharmaceutical Development Services GmbH · EMEA/H/C/006134
Source: European Medicines Agency (EMA), product information
Austria
- Eribulin AccordAccord Healthcare B.V. · 1 register entry
- Eribulin Advanz PharmaAdvanz Pharma Limited · 1 register entry
- Eribulin Ever PharmaEver Valinject Gmbh · 1 register entry
- Eribulin TillomedTillomed Malta Ltd · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- Eribulin AqvidaAqvida Gmbh · 1 register entry
- Eribulin BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Eribulin Ever PharmaEver Valinject Gmbh · 1 register entry
- Eribulin StadaStadapharm Gmbh · 1 register entry
- Eribulin ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- ErlinatVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 27 more European countries
- Belgium
- Eribulin Advanz Pharma, Eribulin Eg, Eribulin Ever Pharma, Eribulin Tillomed Malta
- Bulgaria
- Eribulin Ever Pharma, Sclarint, Ерибулин Stada Arzneimittel, Ерибулин Tilomed, Ерибулин Адвц, Ерибулин Зентива, Ерибулин Стада
- Croatia
- Eribulin
- Czechia
- Erhopana, Eribulin Accord, Eribulin Advz, Eribulin Agmed, Eribulin Ever Pharma, Eribulin Zentiva
- Denmark
- Eribulin Accord, Eribulin Ever Pharma, Eribulin Glenmark, Eribulin Stada, Eribulin Tillomed, Eribulin Viatris, Eribulin Zentiva
- Estonia
- Eribulin
- Finland
- Eribulin
- France
- Eribuline Accord, Eribuline Advanz Pharma, Eribuline Eg, Eribuline Ever Pharma, Eribuline Hikma, Eribuline Tillomed, Eribuline Zentiva
- Greece
- Eribulin Accord, Eribulin Ever Pharma, Eribulin Tillomed
- Hungary
- Eribulin Advz, Eribulin Ever Pharma
- Iceland
- Advz, Eribulin Advanz Pharma, Eribulin Baxter, Eribulin Stada, Eribulin Viatris, Halaven, Mevlyq, Sclarint
- Ireland
- Eribulin Advanz Pharma, Eribulin Ever Pharma, Eribulin Tillomed
- Italy
- Eribulina Advanz Pharma, Eribulina Eg, Eribulina Ever Pharma, Eribulina Glenmark, Eribulina Zentiva
- Latvia
- Eribulin
- Liechtenstein
- Eribulin Baxter, Halaven, Mevlyq
- Lithuania
- Eribulin
- Luxembourg
- Eribulin Eg
- Malta
- Eribulin Tillomed
- Netherlands
- Eribulin Ever Pharma, Eribuline Hikma, Eribuline Tillomed
- Norway
- Eribulin Accord, Eribulin Advanz Pharma, Eribulin Baxter, Eribulin Ever Pharma, Eribulin Glenmark, Eribulin Stada, Eribulin Tillomed, Eribulin Zentiva, Halaven, Mevlyq
- Poland
- Eribulin Accord, Eribulin Ever Pharma
- Portugal
- Eribulina Advanz Pharma, Eribulina Cttq, Eribulina Ever Pharma, Eribulina Hikma
- Romania
- Erhopana, Eribulin Ever Pharma, Nexerelin
- Slovakia
- Eribulin Advz, Eribulin Agmed, Eribulin Ever Pharma
- Slovenia
- Eribulin Ever Pharma
- Spain
- Eribulina
- Sweden
- Eribulin
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Halaven – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/halaven-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.