HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
Posology: The recommended dose of eribulin mesilate as the ready to use solution is 1.4 mg/m2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Please note: In the EU the recommended dose refers to the base of the active substance (eribulin). Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m2. The dose reduction recommendations shown as follows are also shown as the dose of eribulin to be administered based on the strength of the ready to use solution.
In the pivotal trials, the corresponding publication and in some other regions e.g. the US and Switzerland, the recommended dose is based on the salt form (eribulin mesilate).
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
Do not re-escalate the eribulin mesilate dose after it has been reduced.
Patients with hepatic impairment: Impaired liver function due to metastases: The recommended dose of eribulin mesilate 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 mesilate 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 is used in these patients.
Impaired liver function due to cirrhosis: This patient group has not been studied. The doses as previously mentioned 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 PRECAUTIONS).
Paediatric population: There is no relevant use of HALAVEN in children and adolescents for 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 Cautions for Usage). Good peripheral venous access, or a patent central line, should be ensured prior to administration. There is no evidence that eribulin mesilate is a vesicant or an irritant. In the event of extravasation, treatment should be symptomatic. For information relevant to the handling of cytotoxic drugs (see Cautions for Usage).