eribulin mesylate (Halaven)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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What is eribulin mesylate, Halaven, and how does it work (mechanism of action)?

Eribulin mesylate is a chemotherapeutic medicine approved to treat metastatic breast cancer, an advanced form of breast cancer that has spread to other parts of the body.

Microtubules are dynamic intracellular structures that are responsible for various kinds of movements including cell division, organization of intracellular structure, and intracellular transport. Eribulin inhibits the growth phase of microtubules, consequently interfering with cell growth and function and eventually causing cancer cell death. Eribulin was developed from a chemical first isolated from the rare marine sponge, Halichondria okadai.

Eribulin can help some patients with metastatic breast cancer live longer. In one trial, women treated with eribulin lived about 2.5 months longer than women who received other treatments. Eribulin was approved by the FDA in 2010.

What brand names are available for eribulin mesylate, Halaven?

Halaven

Is eribulin mesylate, Halaven available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for eribulin mesylate, Halaven?

Yes

What are the side effects of eribulin mesylate, Halaven?

The most common side effects of eribulin are:

The most common serious side effect is decreased white blood cell counts or neutropenia. White blood cells are necessary to fight infections; therefore, significantly low levels of white blood cells may increase the risk for serious infections that can lead to hospitalization or death.

Peripheral neuropathy (damage to the nerves of the extremities) is the most common side effect that causes patients to stop taking eribulin. Severe peripheral neuropathy occurred in 8% of patients treated with eribulin. Furthermore, 5% of patients experienced neuropathy lasting more than 1 year, while 22% of patients developed new or worsening neuropathy that did not get better after an average of 269 days.

Eribulin also can cause abnormalities in the electrocardiogram such as QT prolongation and changes in the heartbeat rhythm that can potentially cause death.

Eribulin can damage the kidney or liver. Risk for injury is higher in patients who have pre-existing kidney or liver disease. To avoid serious injury, such patients should be treated with a lower dose of eribulin.

Quick GuideBreast Cancer Diagnosis and Treatment

Breast Cancer Diagnosis and Treatment

What is the dosage for eribulin mesylate, Halaven?

The recommended dose of eribulin is 1.4 mg/m2 administered into the vein (intravenously) over 2 to 5 minutes on days 1 and 8 of a 21 day cycle of chemotherapy.

The recommended dose of eribulin in patients with mild liver disease (Child-Pugh A) is 1.1 mg/m2 administered into the vein (intravenously) over 2 to 5 minutes on days 1 and 8 of a 21 day cycle.

The recommended dose of eribulin in patients with moderate liver disease (Child-Pugh B) is 0.7 mg/m2 administered into the vein (intravenously) over 2 to 5 minutes on days 1 and 8 of a 21-day cycle.

The recommended dose of eribulin in patients with moderate or severe kidney disease (creatinine clearance 15-49 ml/min) is 1.1 mg/m2 administered into the vein (intravenously) over 2 to 5 minutes on days 1 and 8 of a 21-day cycle.

The dose of eribulin may need to be decreased or treatment may need to be temporarily or permanently interrupted if patients experience a significant drop in their blood cell counts (red blood cells, white blood cells, and/or platelets) or severe peripheral neuropathy.

Eribulin may be administered undiluted or diluted in 100 ml of 0.9% normal saline (salt water). Eribulin should not be mixed with or administered in the same line as solutions containing dextrose (sugar).

Which drugs or supplements interact with eribulin mesylate, Halaven?

Eribulin may cause abnormal heart beats. Combining eribulin with other drugs with a similar effect on the heart increases the risk of developing abnormal heart beats.

Is eribulin mesylate, Halaven safe to take if I'm pregnant or breastfeeding?

Eribulin has not been adequately evaluated in pregnant women. However, based on the mechanism in which eribulin works in the body, it is expected to cause harm to the unborn baby and therefore, should not be used during pregnancy. In animal studies eribulin caused birth defects in rats. Eribulin is classified as FDA pregnancy risk category D.

It is not known if eribulin is excreted in breast milk. As many drugs enter human milk and can potentially cause harm to the nursing infant, eribulin is not recommended in nursing mothers.

What else should I know about eribulin mesylate, Halaven?

What preparations of eribulin mesylate, Halaven are available?

Solution for intravenous (IV) injection: 1 mg/2 ml. Eribulin is available in single use vials.

How should I keep eribulin mesylate, Halaven stored?

Eribulin should be stored at room temperature, between 15 C to 30 C (59 F to 86 F). Vials should be stored in their original cartons.

After drawing into the syringe, undiluted eribulin can be stored for up to 4 hours at room temperature or for up to 24 hours in the refrigerator (4 C or 40 F).

REFERENCE:

FDA Prescribing Information

Quick GuideBreast Cancer Diagnosis and Treatment

Breast Cancer Diagnosis and Treatment

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Reviewed on 4/20/2015
References
REFERENCE:

FDA Prescribing Information

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