Drug Detail:Halaven (Eribulin [ e-rib-ue-lin ])
Generic Name: ERIBULIN MESYLATE 0.5mg in 1mL
Dosage Form: injection
Drug Class: Mitotic inhibitors
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.
| 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.
