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Halaven Dosage

Generic name: ERIBULIN MESYLATE 0.5mg in 1mL
Dosage form: injection
Drug class: Mitotic inhibitors

Medically reviewed by Drugs.com. Last updated on Sep 17, 2022.

2.1 Recommended Dose

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.

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 [see Use in Specific Populations (8.6)].

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 [see Use in Specific Populations (8.6)].

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 [see Use in Specific Populations (8.7)].

2.2 Dose Modification

Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.

Recommended dose delays

  • Do not administer HALAVEN on Day 1 or Day 8 for any of the following:
    - ANC < 1,000/mm3
    - Platelets < 75,000/mm3
    - Grade 3 or 4 non-hematological toxicities.
  • The Day 8 dose may be delayed for a maximum of 1 week.
    - If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose.
    - If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later.

Recommended dose reductions

  • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1.
  • Do not re-escalate HALAVEN dose after it has been reduced.
Table 1: Recommended Dose Reductions
Event Description Recommended HALAVEN
Dose
Permanently reduce the 1.4 mg/m2 HALAVEN dose for any of the
following:		 1.1 mg/m2
ANC <500/mm3 for >7 days
ANC <1,000 /mm3 with fever or infection
Platelets <25,000/mm3
Platelets <50,000/mm3 requiring transfusion
Non-hematologic Grade 3 or 4 toxicities
Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity
Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 0.7 mg/m2
Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2 Discontinue HALAVEN
ANC = absolute neutrophil count.
Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) version 3.0.

2.3 Instructions for Preparation and Administration

​Aseptically withdraw the required amount of HALAVEN from the single-dose vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP.

Do not dilute in or administer through an intravenous line containing solutions with dextrose. Do not administer in the same intravenous line concurrent with the other medicinal products.

Store undiluted HALAVEN in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration at 4°C (40°F). Store diluted solutions of HALAVEN for up to 4 hours at room temperature or up to 24 hours under refrigeration at 4°C (40°F).

Discard unused portions of the vial.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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