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Halaven Generic Name & Formulations
Legal Class
Rx
General Description
Eribulin mesylate 0.5mg/mL, soln for IV inj.
Pharmacological Class
Non-taxane microtubule dynamics inhibitor.
How Supplied
Single-dose vial (2mL)—1
Manufacturer
Halaven Indications
Indications
Treatment of unresectable or metastatic liposarcoma in patients who have received prior anthracycline-containing regimen.
Halaven Dosage and Administration
Adult
Give by IV inj over 2–5mins. 1.4mg/m² on Days 1 and 8 of a 21-day cycle. Mild hepatic impairment (Child-Pugh A) or moderate-to-severe renal impairment (CrCl 15–49mL/min): 1.1mg/m² on Days 1 and 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B): 0.7mg/m² on Days 1 and 8 of a 21-day cycle. Hold dose for ANC <1000/mm³, platelets <75000/mm³, or grade 3 or 4 non-hematological toxicities. Delay or reduce dose according to toxicities; see full labeling. Do not re-escalate dose after it is reduced.
Children
<18yrs: not established.
Halaven Contraindications
Not Applicable
Halaven Boxed Warnings
Not Applicable
Halaven Warnings/Precautions
Warnings/Precautions
Monitor CBCs prior to each dose; increase frequency of monitoring if grade 3 or 4 cytopenias develop, delay and reduce subsequent doses if febrile neutropenia or grade 4 neutropenia lasting >7 days develops. Monitor for peripheral neuropathy; withhold dose if grade 3 or 4 peripheral neuropathy develops until resolution to grade 2 or less. Congenital long QT syndrome: avoid. CHF, bradyarrhythmias, electrolyte abnormalities: monitor ECG for prolonged QT interval. Correct electrolyte abnormalities (K+, Mg+) before treatment; monitor. Severe hepatic impairment (Child-Pugh C): insufficient data. Embryo-fetal toxicity. Pregnancy (avoid). Use effective contraception during treatment and for ≥2 weeks (females) or 3.5 months (male partners) after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Halaven Pharmacokinetics
See Literature
Halaven Interactions
Interactions
Caution with other drugs that prolong QT interval (eg, Class IA and III antiarrhythmics); monitor.
Halaven Adverse Reactions
Adverse Reactions
Neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, constipation, abdominal pain, pyrexia, hypokalemia, hypocalcemia; febrile neutropenia, possible QT prolongation, elevated liver enzymes.
Halaven Clinical Trials
See Literature
Halaven Note
Notes
Do not mix with dextrose-containing solutions. Do not administer in same line as other drugs or fluids.
Halaven Patient Counseling
See Literature
Halaven Generic Name & Formulations
Legal Class
Rx
General Description
Eribulin mesylate 0.5mg/mL, soln for IV inj.
Pharmacological Class
Non-taxane microtubule dynamics inhibitor.
How Supplied
Single-dose vial (2mL)—1
Manufacturer
Halaven Indications
Indications
Treatment of metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Halaven Dosage and Administration
Adult
Give by IV inj over 2–5mins. 1.4mg/m² on Days 1 and 8 of a 21-day cycle. Mild hepatic impairment (Child-Pugh A) or moderate-to-severe renal impairment (CrCl 15–49mL/min): 1.1mg/m² on Days 1 and 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B): 0.7mg/m² on Days 1 and 8 of a 21-day cycle. Hold dose for ANC <1000/mm³, platelets <75000/mm³, or grade 3 or 4 non-hematological toxicities. Delay or reduce dose according to toxicities; see full labeling. Do not re-escalate dose after it is reduced.
Children
<18yrs: not established.
Halaven Contraindications
Not Applicable
Halaven Boxed Warnings
Not Applicable
Halaven Warnings/Precautions
Warnings/Precautions
Monitor CBCs prior to each dose; increase frequency of monitoring if grade 3 or 4 cytopenias develop, delay and reduce subsequent doses if febrile neutropenia or grade 4 neutropenia lasting >7 days develops. Monitor for peripheral neuropathy; withhold dose if grade 3 or 4 peripheral neuropathy develops until resolution to grade 2 or less. Congenital long QT syndrome: avoid. CHF, bradyarrhythmias, electrolyte abnormalities: monitor ECG for prolonged QT interval. Correct electrolyte abnormalities (K+, Mg+) before treatment; monitor. Severe hepatic impairment (Child-Pugh C): insufficient data. Embryo-fetal toxicity. Pregnancy (avoid). Use effective contraception during treatment and for ≥2 weeks (females) or 3.5 months (male partners) after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Halaven Pharmacokinetics
See Literature
Halaven Interactions
Interactions
Caution with other drugs that prolong QT interval (eg, Class IA and III antiarrhythmics); monitor.
Halaven Adverse Reactions
Adverse Reactions
Neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, constipation, abdominal pain, pyrexia, hypokalemia, hypocalcemia; febrile neutropenia, possible QT prolongation, elevated liver enzymes.
Halaven Clinical Trials
See Literature
Halaven Note
Notes
Do not mix with dextrose-containing solutions. Do not administer in same line as other drugs or fluids.
Halaven Patient Counseling
See Literature
