Eribulin mesilate parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection containing eribulin (as mesilate)
Advanced/metastatic breast cancer after previous cytotoxic therapy failure
Advanced/metastatic unresectable liposarcoma
Treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
Treatment of patients with unresectable liposarcoma who have been treated with an anthracycline containing therapy, unless patient was not suitable, for advanced or metastatic disease.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
The recommended dose is 1.23 mg per square metre of body surface area (BSA), administered intravenously over 2 to 5 minutes on days 1 and 8 of every 21 day cycle.
Antiemetic prophylaxis including corticosteroids should be considered.
The recommended dose is 1.23 mg per square metre BSA, administered intravenously over 2 to 5 minutes on days 1 and 8 of every 21 day cycle.
Antiemetic prophylaxis including corticosteroids should be considered.
Patients with Renal Impairment
Patients with moderate to severe renal impairment (creatinine clearance less than 50 ml/minute) may have increased eribulin exposure and may require a dose reduction.
The renal drug handbook suggests the following dose reductions
Glomerular filtration rate (GFR) greater than 40 ml/minute: Dose as normal.
GFR between 30 and 40 ml/minute: 1.1 mg per square metre BSA.
GFR: less than 30 ml/minute: Reduce dose.
Patients with Hepatic Impairment
Mild hepatic impairment (Child-Pugh A)
0.97 mg per square metre BSA administered intravenously over 2 to 5 minutes on days 1 and 8 of a 21 day cycle.
Moderate hepatic impairment (Child-Pugh B)
0.62 mg per square metre BSA administered intravenously over 2 to 5 minutes on days 1 and 8 of a 21 day cycle.
Severe hepatic impairment (Child-Pugh C)
This group has not been studied but it is expected that a more marked dose reduction is needed.
Additional Dosage Information
Dose delays during therapy
The administration of eribulin should be delayed on days 1 and 8 for any of the following:
Absolute neutrophil count (ANC) is less than 1 x 10 to the power of 9 per litre.
Platelets are less than 75 x 10 to the power of 9 per litre.
Grade 3 or 4 non-haematological toxicities.
Recommended dose reductions:
1st reduction: 0.97 mg per square metre BSA.
2nd reduction: 0.62 mg per square metre BSA.
3rd reduction: Discontinue treatment.
Reduce dose if any of the following adverse reactions occur:
ANC less than 0.5 x 10 to the power of 9 per litre lasting more than 7 days.
ANC less than 1 x 10 to the power of 9 per litre, neutropenia complicated by fever or infection.
Platelets less than 25 x 10 to the power of 9 per litre, thrombocytopenia.
Platelets less than 50 x 10 to the power of 9 per litre, thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion.
Any Grade 3 or 4 non-haematological toxicity in the previous cycle.
For intravenous injection or infusion only.
Good peripheral venous access, or a patent central line, should be ensured prior to administration.
Children under 18 years
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Platelet count below 100 x 10 to the power of 9 / L at baseline
Long QT syndrome
Precautions and Warnings
Family history of long QT syndrome
Congestive cardiac failure
History of torsade de pointes
Mild hepatic impairment
Renal impairment - creatinine clearance below 50ml/minute
Serum bilirubin above 1.5 times upper limit of normal
Serum transaminases above 3 times upper limit of normal
Administration of live vaccines is not recommended
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider premedication with a corticosteroid
Give pre-treatment counselling and consideration of sperm cryopreservation
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Staff: Not to be handled by pregnant staff
Correct hypokalaemia before treatment
Correct hypomagnesaemia prior to administration
Monitor serum electrolytes before and during treatment
Monitor closely patient with pre-existing renal impairment
Monitor complete blood counts before each dose
Monitor ECG in patients at risk of QT prolongation
Monitor for symptoms of peripheral neuropathy
Reduce dose if neutrophil count < 500 cells/cubic mm for more than 7 days
Advise patient to report signs of neuropathy
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Consider G-CSF in severe neutropenia / agranulocytosis
Delay treatment if neutrophil count less than 1 x 10 to the power of 9/L
Delay treatment if platelet count less than 75 x 10 to the power of 9/L
Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
Suspend treatment or reduce dose if peripheral neuropathy occurs
Consider dose reduction in renal impairment
Reduce dose if neutrophil count <1 x 10 to power 9/L with fever/infection
Reduce dose if platelets <25 x 10 to the power of 9/L
Male & female: Contraception required during & for 3 months after treatment
Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines.
Patients with ALT or AST above 3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Limited data indicate that patients with bilirubin above 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Pregnancy and Lactation
Eribulin is contraindicated in pregnancy.
At the time of writing there is no information on the use of eribulin in pregnant women. Studies in rats have shown embryotoxic, foetotoxic, and teratogenic effects. Eribulin should not be given unless the potential benefit to the mother outweighs the risk to the foetus.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Eribulin is contraindicated in breastfeeding.
At the time of writing it is unknown whether eribulin is excreted in human breast milk, a risk to neonates cannot be excluded.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Alanine aminotransferase increased
Aspartate aminotransferase increased
Candidiasis (mouth or throat)
Deep vein thrombosis (DVT)
Gastroesophageal reflux disease
Increases in hepatic enzymes
Interstitial lung disease
Intravascular coagulation (disseminated)
Prolongation of QT interval
Upper respiratory tract infection
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2015
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 19 May 2015.
Summary of Product Characteristics: Halaven 0.44mg/ml solution for injection. Eisai Ltd. Revised May 2016.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
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