Eribulin

What is Eribulin?

• Eribulin (Halaven) is a microtubule inhibitor used as an antineoplastic agent for refractory, metastatic breast cancer and liposarcoma.

Eribulin

What are the uses of this medicine?

Eribulin (Halaven) is used to treat people with: Breast cancer

• that has spread to other parts of the body, and
• who have already received certain types of anticancer medicines after the cancer has spread

Liposarcoma

• that cannot be treated with surgery or has spread to other parts of the body, and
• who have received treatment with a certain type of anticancer medicine

How does this medicine work?

• Eribulin (er' i bue' lin) is a synthetic macrocyclic analogue of halichondrin B, a naturally occurring inhibitor of mitotic division
• found in a species of marine sponges (Halichondria okadai).
• Eribulin binds to the growing ends of microtubules preventing cell division (mitotic arrest) which leads to tubulin sequestration in aggregates and apoptotic cell death.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P-glycoprotein (P-gp) inhibitors.

Is this medicine FDA approved?

• Eribulin was approved for use in cancer chemotherapy in 2010 and current indications are for metastatic breast cancer after failure of chemotherapy with an anthracycline and taxane.
• It is also approved for use in metastatic, refractory liposarcoma.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Halaven is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

Hepatic impairment:

• The recommended dose of Halaven in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
• The recommended dose of Halaven in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
• The recommended dose of Halaven in patients with moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

• Do not mix with other drugs or administer with dextrose-containing solutions.

Administration:

• Halaven is given by intravenous (IV) injection in your vein.
• Halaven is given in “cycles” of treatment, with each cycle lasting 21 days.
• Halaven is usually given on day 1 and day 8 of a treatment cycle.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1 mg per 2 mL (0.5 mg per mL) eribulin mesylate in a single-dose vial

This medicine is available in fallowing brand namesː

• Halaven

What side effects can this medication cause?

The most common side effects of Halaven in people with breast cancer include:

• low white blood cell count (neutropenia)
• low red blood cell count (anemia)
• weakness or tiredness
• hair loss (alopecia)
• nausea
• constipation

The most common side effects of Halaven in people with liposarcoma include:

• tiredness
• nausea
• hair loss (alopecia)
• constipation
• stomach pain
• fever

Halaven may cause serious side effects, including:

• neutropenia
• peripheral neuropathy
• QT prolongation

What special precautions should I follow?

• Severe neutropenia lasting more than one week occurred in patients with metastatic breast cancer. Monitor peripheral blood cell counts and adjust dose as appropriate.
• Peripheral neuropathy was the most common toxicity leading to discontinuation of Halaven. Monitor for signs of neuropathy. Manage with dose delay and adjustment.
• Based on findings from an animal reproduction study and its mechanism of action, Halaven can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
• QT prolongation was observed with Halaven. Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• neutropenia
• hypersensitivity reaction

Management of overdosage:

• There is no known antidote for Halaven overdose.
• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• Halaven can cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Halaven during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Halaven in pediatric patients below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: eribulin mesylate
• Inactive Ingredients: dehydrated alcohol, water for injection, and sodium hydroxide or hydrochloric acid may be used for pH adjustment.

Who manufactures and distributes this medicine?

Distributed by: Eisai Inc. Nutley, NJ Halaven® is a registered trademark used by Eisai Inc.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F).
• Do not freeze or refrigerate.
• Store the vials in their original cartons.
• Halaven injection is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

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• Dailymed label info on Eribulin
• FDA Eribulin