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eribulin mesylate (Halaven): Chemotherapy Side Effects & Treatment

What is Halaven? What is Halaven used for?

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

What are the side effects of 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.




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What is the dosage for 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).

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Which drugs or supplements interact with 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 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 Halaven?

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).

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