Halaven Dosage/Direction for Use

HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
Route of administration: Intravenous injection.
Posology: The recommended dose of eribulin mesylate as the ready to use solution is 1.4 mg/m² (equivalent to 1.23 mg/m² eribulin) which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Patients may experience nausea or vomiting. Antiemetic prophylaxis including corticosteroids should be considered.
Dose delays during therapy: The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following: Absolute neutrophil count (ANC) < 1 x 10⁹/l; Platelets < 75 x 10⁹/l; Grade 3 or 4 non-hematological toxicities.
Dose reduction during therapy: Dose reduction recommendations for retreatment are shown in the following table. (See Table 4.)

Click on icon to see table/diagram/image

The dose of eribulin should not be re-escalated after it has been reduced.
Patients with hepatic impairment: Impaired liver function due to metastases: The recommended dose of eribulin mesylate 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. The recommended dose of eribulin mesylate 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.
Severe hepatic impairment (Child-Pugh C) has not been studied but it is expected that a more marked dose reduction is needed if eribulin mesylate is used in these patients.
Impaired liver function due to cirrhosis: This patient group has not been studied. The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
Patients with renal impairment: Some patients with moderately or severely impaired renal function (creatinine clearance <50 ml/min) may have increased eribulin exposure and may need a reduction of the dose. For all patients with renal impairment, caution and close safety monitoring is advised. (See Pharmacology: Pharmacokinetics under Actions.)
Elderly patients: No specific dose adjustments are recommended based on the age of the patient (see Adverse Reactions).
Paediatric population: There is no relevant use of HALAVEN in children and adolescents in the indication of breast cancer.
The safety and efficacy of HALAVEN in children from birth to 18 years of age have not yet been established in soft tissue sarcoma. No data are available.
Method of administration: HALAVEN is for intravenous use. The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. It should not be diluted in glucose 5% infusion solution. For instructions on the dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage. Good peripheral venous access, or a patent central line, should be ensured prior to administration. There is no evidence that eribulin mesylate is a vesicant or an irritant. In the event of extravasation, treatment should be symptomatic. For information relevant to the handling of cytotoxic medicinal products, see Special precautions for disposal and other handling under Cautions for Usage.