eribulin mesylate (Halaven)

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 Halaven?

Halaven

Is Halaven available as a generic drug?

No

Do I need a prescription for Halaven?

Yes

The most common side effects of eribulin are:

• low white blood cells,
• low red blood cells,
• weakness,
• tiredness,
• hair loss,
• constipation,
• nausea, and
• numbness, tingling, or burning in the hands and feet (peripheral neuropathy).

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.

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).

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.

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 preparations of Halaven are available?

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

How should I keep 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).