Usual Adult Dose for Breast Cancer

1.4 mg/m2 IV over 2 to 5 minutes on days 1 and 8 of a 21-day cycle

Comments:

• This drug should be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
• Patients may experience nausea or vomiting. Antiemetic prophylaxis including corticosteroids should be considered.
• Peripheral neuropathy should be assessed and complete blood cell counts should be obtained prior to each dose.

Renal Dose Adjustments

• Mild renal impairment (CrCl 50 to 80 mL/min): No adjustment recommended
• Moderate renal impairment (CrCl 30 to 50 mL/min): 1.1 mg/m2 IV over 2 to 5 minutes on days 1 and 8 of a 21-day cycle.
• Severe renal impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

• Mild liver impairment (Child-Pugh A): 1.1 mg/m2 intravenously over 2 to 5 minutes on days 1 and 8 of a 21-day cycle
• Moderate liver impairment (Child-Pugh B): 0.7 mg/m2 intravenously over 2 to 5 minutes on days 1 and 8 of a 21-day cycle
• Severe liver impairment (Child-Pugh C): Data not available

Dose Adjustments

PLEASE NOTE:

• In the EU the recommended dose refers to the base of the active substance (eribulin). Calculation of the individual dose to be administered to a patient should be based on the strength of the ready to use solution that contains 0.44 mg/mL eribulin.
• In some other regions (e.g., the US and other countries), the recommended dose is based on the salt form (eribulin mesylate).

• The patient is experiencing grade 3 or 4 non-hematological toxicities
• The absolute neutrophil count (ANC) is less than 1000 cells/mm3
• Platelets are less than 75,000/mm3.

• Toxicities do not resolve or improve to less than or equal to grade 2 by day 15, the dose should be omitted
• Toxicities resolve or improve to less than or equal to grade 2 severity by day 15, this drug should be administered at a reduced dose and the next cycle should be initiated at least 2 weeks later

• Absolute neutrophil count (ANC) less than 500 cells/mm3 for more than 7 days
• ANC less than 1000 cells/mm3 with fever or infection
• Platelets less than 25,000/mm3
• Platelets less than 50,000/mm3 requiring transfusion
• Non-hematologic grade 3 or 4 toxicities
• Omission or delay of day 8 dose in previous cycle for toxicity

• The occurrence of any adverse event requiring permanent dose reduction while receiving the 1.1 mg/m2 dose, the dose should be further reduced to 0.7 mg/m2.

• The occurrence of any adverse event requiring permanent dose reduction while receiving the 0.7 mg/m2 dose, this drug should be discontinued.

Precautions

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

• The manufacturer product information should be consulted for recommended storage requirements.

• The dose should be diluted in up to 100 mL of sodium chloride 0.9% solution for injection. It should not be diluted in glucose 5% infusion solution.

• This drug should not be diluted in or administered through an IV line containing dextrose solutions or mixed with any other medicinal agents.

• Good peripheral venous access or a patent central line should be obtained prior to administration.
• If extravasation occurs, treatment should be symptomatic.

• A complete blood count is recommended prior to each dose and increased monitoring is recommended in patients who develop grade 3 or 4 cytopenias.
• Patients should be closely monitored for the development of neuropathies.
• Electrocardiogram (ECG) monitoring is recommended in patients at risk of developing QT interval prolongation. Use should be avoided in patients with congenital long QT syndrome.
• Electrolyte abnormalities should be corrected prior to initiation of the dose and periodic monitoring of electrolytes is recommended during therapy.

• This drug can cause a decrease in white blood cell count (neutropenia). This can make you more likely to get serious infections that could lead to death. You may need treatment in the hospital with antibiotic medicines.
• Call your healthcare provider right away if you develop any of these symptoms of infection while you are receiving this drug: Fever (temperature above 100.5F), chills, cough, burning or pain when you urinate.
• This drug can cause numbness, tingling, or burning in your hands and feet (neuropathy). Tell your healthcare provider if you have any of these symptoms.
• Tell your healthcare provider if you have liver or kidney problems, heart problems, including a problem called "congenital long QT syndrome", are pregnant or plan to become pregnant, are breastfeeding or planning to breastfeed.
• The most common side effects of this drug are: Weakness or tiredness, hair loss, nausea, and constipation.