Eribulin

IV Incompatibilities

Additive: Dextrose

Y-site: Dextrose

IV Compatibilities

Solution: 0.9% NaCl

IV Preparation

Clear, colorless, sterile solution for IV administration

Each vial contains 1 mg of eribulin mesylate as a 0.5 mg/mL solution in ethanol:water (5:95)

IV infusion: Aseptically withdraw dose; may be administered undiluted or diluted (in 0.9% NaCl 100 mL)

Discard unused portion of vial

IV Administration

May be administered undiluted or diluted (in 0.9% NaCl 100 mL)

Administer over 2-5 minutes

Do not dilute in or administer through IV line contain solutions with dextrose

Do not administer in same IV line concurrent with other medical products

Storage

Store undiluted eribulin in syringe for up to 4 hr at room temperature or for up to 24 hr under refrigeration (40°F or/ 4°C)

Store diluted solutions of eribulin for up to 4 hr at room temperature or up to 24 hr under refrigeration (40°F or/ 4°C)

• Eribulin is injected directly into your vein.
• Eribulin is given in "cycles" of treatment, with each cycle lasting 21 days.
• You will receive an injection 1 time each week for two weeks in a row (day 1 and day 8 of a treatment cycle).
• Your healthcare provider may need to decrease your dose or change how often you receive it, depending on your blood test results.

• Tell all of your health care providers that you take eribulin. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect being able to father a child. It is not known how long this effect lasts. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 14 weeks after your last dose. Use birth control that you can trust.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking eribulin and for at least 2 weeks after stopping the drug.

• If you need to store eribulin at home, talk with your doctor, nurse, or pharmacist about how to store it.

(er i BUE lin)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as mesylate:

Halaven: 1 mg/2 mL (2 mL) [contains alcohol, usp]

Refer to adult dosing.

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Consider therapy modification

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Adverse effects were observed in animal reproduction studies. Based on its mechanism of action, eribulin would be expected to cause fetal harm if administered during pregnancy. Women of reproductive potential should use effective contraception to avoid pregnancy during eribulin treatment and for at least 2 weeks following the last eribulin dose; males with female partners of reproductive potential should use effective contraception during eribulin treatment and for 3.5 months following the last dose. The Canadian labeling recommends effective contraception during and for at least 3 months after treatment in women of reproductive potential.

-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

-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