Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: YES Pharmaceutical Development Services GmbH, Basler Strasse 7, 61352 Bad Homburg, Germany
Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
Mevlyq should only be prescribed by a qualified physician experienced in the appropriate use of anticancer therapy. It should be administered by an appropriately qualified healthcare professional only.
The recommended dose of eribulin as the ready to use solution is 1.23 mg/m² which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Please note: 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 below 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 publications and in some other regions e.g. the United States 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.
The administration of Mevlyq should be delayed on Day 1 or Day 8 for any of the following:
Dose reduction recommendations for retreatment are shown in the following table.
Dose reduction recommendations:
| Adverse reaction after previous Mevlyq administration | Recommended dose of eribulin |
|---|---|
| Haematological | |
| ANC < 0.5 × 109/L lasting more than 7 days | 0.97 mg/m² |
| ANC < 1 × 109/L neutropenia complicated by fever or infection | |
| Platelets < 25 × 109/L thrombocytopenia | |
| Platelets < 50 × 109/L thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion | |
| Non-haematological | |
| Any Grade 3 or 4 in the previous cycle | |
| Reoccurrence of any haematological or non-haematological adverse reactions as specified above | |
| Despite reduction to 0.97 mg/m² | 0.62 mg/m² |
| Despite reduction to 0.62 mg/m² | Consider discontinuation |
The dose of eribulin should not be re-escalated after it has been reduced.
The recommended dose of eribulin in patients with mild hepatic impairment (Child-Pugh A) is 0.97 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. The recommended dose of eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.62 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.
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.
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 section 5.2).
No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
There is no relevant use of Mevlyq in children and adolescents for the indication of breast cancer.
The safety and efficacy of Mevlyq in children from birth to 18 years of age have not yet been established in soft tissue sarcoma. No data are available.
Mevlyq 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 section 6.6. 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 medicinal products see section 6.6.
In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia (Grade 3) on Day 7. Both adverse reactions resolved with supportive care.
There is no known antidote for eribulin overdose. In the event of an overdose, the patient should be closely monitored. Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.
Unopened vials: 2 years
In-use shelf life: Chemical and physical in-use stability of the undiluted solution in a syringe has been demonstrated for 4 hours at 25°C and 24 hours at 2°C-8°C.
Chemical and physical in-use stability of the diluted solution has been demonstrated for 72 hours at 2°C-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°, unless dilution has taken place in controlled and validated aseptic conditions.
This medicinal product does not require any special storage conditions.
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
4 mL type I colourless glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 mL of solution.
The pack size is 1 vial.
Mevlyq is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling. The use of gloves, goggles, and protective clothing is recommended. If the skin comes into contact with the solution, it should be washed immediately and thoroughly with soap and water. If it contacts mucous membranes, the membranes should be flushed thoroughly with water. Mevlyq should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents. Pregnant staff should not handle Mevlyq.
Using aseptic technique Mevlyq can be diluted up to 100 ml with sodium chloride 9 mg/mL (0.9%) solution for injection. Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection to ensure administration of the complete dose. It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
If using a spike to administer the product refer to the instructions provided from the device manufacturer. Mevlyq vials have a 13 mm stopper. The device selected should be compatible with small vial stoppers.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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