Europe — EMA
Halaven
Halaven (eribulin) is an IV antineoplastic drug for metastatic breast cancer and liposarcoma, detailing uses, side effects, precautions, and interactions.
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What is Eribulin?
Halaven is a prescription intravenous solution containing the active ingredient eribulin. It is formulated for administration by infusion and is classified as a microtubule dynamics inhibitor. Halaven is used in the European market as an antineoplastic agent for specific cancer types. The product does not have a listed strength, and it is supplied only with a healthcare professional’s supervision.
What is Eribulin used for?
Halaven is indicated for the treatment of certain advanced solid tumors in patients who have previously received chemotherapy. It is administered under the direction of an oncologist and is part of a broader cancer management plan.
- Metastatic breast cancer that has progressed after at least two prior chemotherapy regimens. - Unresectable or metastatic liposarcoma in patients who have received prior systemic therapy. - As part of combination therapy protocols when clinically appropriate. - In patients with measurable disease as defined by RECIST criteria. - For use in clinical settings where intravenous infusion is feasible.
What are the side effects of Eribulin?
Eribulin may cause a range of side effects, some of which are more frequently observed while others are less common but potentially serious.
Common: - Fatigue or weakness that may affect daily activities. - Nausea and occasional vomiting, often manageable with anti‑emetics. - Decreased white blood cell counts, increasing infection risk. - Peripheral neuropathy presenting as tingling or numbness in extremities. - Mild to moderate hair loss. - Decreased platelet count leading to easy bruising.
Serious: - Severe neutropenia with fever, indicating possible infection. - Significant liver enzyme elevations suggesting hepatic toxicity. - Cardiac events such as arrhythmias or decreased ejection fraction. - Severe peripheral neuropathy causing functional impairment. - Life‑threatening allergic reactions including anaphylaxis. - Tumor lysis syndrome in patients with high tumor burden.
What precautions apply to Eribulin?
Before initiating Halaven therapy, clinicians should evaluate patient history and monitor specific clinical parameters throughout treatment.
- Assess baseline blood counts and liver function tests; repeat regularly. - Monitor for signs of infection due to neutropenia. - Evaluate cardiac function, especially in patients with pre‑existing heart disease. - Use caution in patients with pre‑existing peripheral neuropathy. - Adjust dose or discontinue if severe adverse events occur. - Counsel patients on contraception and potential pregnancy risks. - Provide patient education on recognizing symptoms of serious side effects.
What does Eribulin interact with?
Eribulin may interact with other medications, affecting its safety profile or therapeutic efficacy.
Avoid: - Concurrent use of strong CYP3A4 inducers that may reduce eribulin exposure. - Live vaccines during periods of significant neutropenia. - Other myelosuppressive agents without dose adjustments.
Use with caution: - Antiemetic agents that may prolong QT interval. - Drugs known to cause peripheral neuropathy, such as certain antiretrovirals. - Medications that affect hepatic metabolism, including some antifungals. - Herbal supplements that influence liver enzymes, like St. John's wort.
Frequently asked questions
What type of medication is Halaven and how is it administered?+
For which cancers is Halaven approved in the European Union?+
How does eribulin work to inhibit tumor growth?+
What are the most common side effects patients may experience with Halaven?+
Which serious adverse reactions require immediate medical attention?+
What laboratory tests are recommended before and during Halaven treatment?+
Can Halaven be used in pregnant or breastfeeding women?+
Are there any medications that should be avoided while receiving Halaven?+
What precautions should be taken when a patient has pre‑existing peripheral neuropathy?+
How should clinicians manage neutropenia caused by Halaven?+
Is dose adjustment required for patients with liver impairment?+
What patient education is important before starting Halaven therapy?+
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