Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Eribulin contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.
It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.
It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.
Do not use Eribulin: • if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding
Warnings and precautions Talk to your doctor or nurse before using Eribulin:
• if you have liver problems
• if you have a fever or an infection
• if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness
• if you have heart problems
If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Children and adolescents Do not give this medicine to children between the ages of 0 to 18 years because it does not work.
Other medicines and Eribulin Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility Eribulin may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment. Women of childbearing potential must use highly effective contraception during treatment with eribulin and for 7 months after treatment.
Eribulin must not be used during breast-feeding because of the possibility of risk to the child.
Men with a partner of childbearing potential should not father a child while receiving treatment with eribulin. Men must use an effective method of contraception while taking eribulin and for 4 months after treatment.
Driving and using machines Eribulin may cause side effects such as tiredness (very common) and dizziness (common). Do not drive or use machines if you feel tired or dizzy.
Eribulin contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
Eribulin will be given to you by a qualified healthcare professional as an injection into a vein, over a period of 2 to 5 minutes. The dose you will receive is based on your body surface area (expressed in squared metres, or m 2 ) which is calculated from your weight and height. The usual dose of eribulin is 1.23 mg/m 2 , but this may be adjusted by your doctor based on your blood test results or other factors. To ensure that the whole dose of eribulin is given it is recommended that a saline solution is flushed into the vein after eribulin is given.
How often will you be given Eribulin? Eribulin is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.
If you have any further questions about the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious symptoms, stop taking Eribulin and seek medical attention straightaway:
• Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion. These may be signs of a condition called sepsis – a severe and serious reaction to an infection. Sepsis is uncommon (may affect up to 1 in 100 people) and can be life threatening and may result in death.
• Any difficulty breathing, or swelling of your face, mouth, tongue or throat. These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
• Serious skin rashes with blistering of the skin, mouth, eyes and genitals. These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is not known but it can be life-threatening.
Other side effects: Very common side effects (may affect more than 1 in 10 people) are:
• Decrease in the number of white blood cells or red blood cells
• Tiredness or weakness
• Nausea, vomiting, constipation, diarrhoea
• Numbness, tingling or prickling sensations
• Fever
• Loss of appetite, weight loss
• Difficulty breathing, cough
• Pain in the joints, muscles and back
• Headache
• Hair loss
Common side effects (may affect up to 1 in 10 people) are:
• Decrease in the number of platelets (which may result in bruising or taking longer to stop bleeding)
• Infection with fever, pneumonia, chills
• Fast heart rate, flushing
• Vertigo, dizziness
• Increased production of tears, conjunctivitis (redness and soreness of the surface of the eye), nosebleed
• Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness
• Mouth, respiratory and urinary tract infections, painful urination
• Sore throat, sore or runny nose, flu-like symptoms, throat pain
• Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• Inability to sleep, depression, changed sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Shingles
• Swelling of the skin and numbness of the hands and feet
Uncommon side effects (may affect up to 1 in 100 people) are:
• Blood clots
• Abnormal liver function tests (hepatoxicity)
• Kidney failure, blood or protein in the urine
• Widespread inflammation of the lungs which may lead to scarring
• Inflammation of the pancreas
• Mouth ulcers
Rare side effects (may affect up to 1 in 1000 people) are:
• A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions
If Eribulin is diluted for infusion, the diluted solution should be used immediately. If not used immediately the diluted solution should be stored at 15-25°C for no longer than 48 hours or at 2-8°C for no longer than 72 hours.
If Eribulin as an undiluted solution has been transferred into a syringe, it should be stored at 15-25°C and ambient lighting for no longer than 48 hours, or at 2- 8°C for no longer than 72 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Eribulin contains • The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
• The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.
What Eribulin looks like and contents of the pack Eribulin is a clear, colourless aqueous solution for injection, pH between 7.0 and 9.2 provided in glass vials containing 2 ml of solution. Each carton contains either 1 or 6 vials.
Marketing Authorisation Holder and Manufacturer Dr. Reddy's Laboratories (UK) Ltd.
410 Cambridge Science Park
Milton Road
Cambridge
CB4 0PE
United Kingdom
This leaflet was last revised in April 2026.
Dr. Reddy's Laboratories (UK) Ltd
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Eribulin 0.44 mg/ml solution for injection comes as injection containing 0.44mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Eribulin 0.44 mg/ml solution for injection is eribulin mesilate.
Medicines with the same active substance, strength and form include: Eribulin 0.44 mg/mL solution for injection, Eribulin 0.44 mg/ml Solution for injection, Eribulin 0.44 mg/ml solution for injection. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Eribulin 0.44 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Eribulin 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.
Eribulin 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).
Eribulin should only be prescribed by a qualified physician experienced in the appropriate use of anti-cancer therapy. It should be administered by an appropriately qualified healthcare professional only.
Posology
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:
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 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.
Dose delays during therapy
The administration of Eribulin 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.
Dose reduction recommendations
Adverse reaction after previous eribulin administration
Recommended dose of eribulin
Haematological:
ANC < 0.5 x 109/l lasting more than 7 days
0.97 mg/m2
ANC < 1 x 109/l neutropenia complicated by fever or infection
Platelets < 25 x 109/l thrombocytopenia
Platelets < 50 x 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.
Patients with hepatic impairment
Impaired liver function due to metastases
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.
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 section 5.2)
Elderly patients
No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
Paediatric population
There is no relevant use of eribulin in children and adolescents for the indication of breast cancer.
There is no relevant use of Eribulin in the paediatric population for the indication of soft tissue sarcoma (see section 5.1).
Method of administration
Eribulin 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.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Breast-feeding
Haematology
Myelosuppression is dose dependent and primarily manifested as neutropenia (section 4.8). Monitoring of complete blood counts should be performed on all patients prior to each dose of eribulin. Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Febrile neutropenia occurred in < 5% of patients treated with eribulin. Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in section 4.2.
Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see section 5.1).
Peripheral neuropathy
Patients should be closely monitored for signs of peripheral motor and sensory neuropathy. The development of severe peripheral neurotoxicity requires a delay or reduction of dose (see section 4.2)
In clinical trials, patients with pre-existing neuropathy greater than Grade 2 were excluded. However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
QT prolongation
In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias or concomitant treatment with medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected prior to initiating eribulin and these electrolytes should be monitored periodically during therapy. Eribulin should be avoided in patients with congenital long QT syndrome.
Excipients
This medicine contains 78.9 mg of alcohol (ethanol) in each vial. The amount in of this medicine is equivalent to less than 5.8 ml beer or 2.32 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Eribulin is mainly (up to 70%) eliminated through biliary excretion. The transport protein involved in this process is unknown. Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic anion (OAT1, OAT3, OATP1B1, OATP1B3), multi-drug resistance-associated protein (MRP2, MRP4) and bile salt export pump (BSEP) transporters.
No drug-drug interactions are expected with CYP3A4 inhibitors and inducers. Eribulin exposure (AUC and Cmax) was unaffected by ketoconazole, a CYP3A4 and P glycoprotein (Pgp) inhibitor, and rifampicin, a CYP3A4 inducer.
Effects of eribulin on the pharmacokinetics of other medicines
In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4. No in vivo data are available. Caution and monitoring for adverse events is recommended with concomitant use of substances that have a narrow therapeutic window and that are eliminated mainly via CYP3A4-mediated metabolism (e.g. alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concentrations.
At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
Pregnancy
There are no data from the use of eribulin in pregnant women. Eribulin is embryotoxic, foetotoxic, and teratogenic in rats. eribulin should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Women of childbearing potential must be advised to avoid becoming pregnant whilst they are receiving eribulin and must use highly effective contraception during treatment with eribulin and for 7 months after treatment.
Men with partners of child-bearing potential should be advised not to father a child while receiving eribulin and must use effective contraception during eribulin treatment and for 4 months after treatment.
Breast-feeding
It is unknown whether eribulin/metabolites are excreted in human or animal breast milk. A risk to newborns/infants cannot be excluded and therefore eribulin must not be used during breast-feeding (see section 4.3).
Fertility
Testicular toxicity has been observed in rats and dogs (see section 5.3). Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with eribulin.
Eribulin may cause adverse reactions such as tiredness and dizziness which may lead to minor or moderate influence on the ability to drive or use machines. Patients should be advised not to drive or use machines if they feel tired or dizzy.
Summary of safety profile
The most commonly reported adverse reactions related to eribulin, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections. New onset or worsening of pre-existing peripheral neuropathy has also been reported. Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects. Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.
Tabulated list of adverse reactions
Unless otherwise noted, the table shows the incidence rates of adverse reactions observed in breast cancer and soft tissue sarcoma patients who received the recommended dose in Phase 2 and Phase 3 studies.
Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Where Grade 3 or 4 reactions occurred, the actual total frequency and the frequency of Grade 3 or 4 reactions are given.
System Organ Class
Adverse Reactions – all Grades
Very Common
(Frequency %)
Common
(Frequency %)
Uncommon
(Frequency %)
Rare or not known
Infections and infestations
Urinary tract infection (8.5%) (G3/4: 0.7%)
Pneumonia (1.6%)
(G3/4: 1.0%)
Oral candidiasis
Oral herpes
Upper respiratory tract infection
Nasopharyngitis
Rhinitis
Herpes zoster
Sepsis (0.5%)
(G3/4: 0.5%)a
Neutropenic sepsis
(0.2%) (G3/4: 0.2%)a
Septic Shock (0.2%)
(G3/4:0.2%)a
Blood and lymphatic system disorders
Neutropenia (53.6%)
(G3/4: 46.0%)
Leukopenia (27.9%)
(G3/4: 17.0%)
Anaemia (21.8%)
(G3/4: 3.0%)
Lymphopenia (5.7%)
(G3/4: 2.1%)
Febrile neutropenia
(4.5%) (G3/4: 4.4%)a
Thrombocytopenia
(4.2%) (G3/4: 0.7%)
*Disseminated intravascular coagulationb
Metabolism and nutrition disorders
Decreased appetite
(22.5%) (G3/4: 0.7%)d
Hypokalaemia (6.8%)
(G3/4: 2.0%)
Hypomagnesaemia
(2.8%) (G3/4: 0.3%)
Dehydration (2.8 %)
(G3/4: 0.5%)d
Hyperglycaemia
Hypophosphataemia
Hypocalcaemia
Psychiatric disorders
Insomnia
Depression
Nervous system disorders
Peripheral neuropathyc
(35.9%) (G3/4: 7.3%)
Headache (17.5%)
(G3/4: 0.7%)
Dysgeusia
Dizziness (9.0%)
(G3/4: 0.4%)d
Hypoaesthesia
Lethargy
Neurotoxicity
Eye disorders
Lacrimation increased
(5.8%) (G3/4: 0.1%)d
Conjunctivitis
Ear and labyrinth disorders
Vertigo
Tinnitus
Cardiac disorders
Tachycardia
Vascular disorders
Hot flush
Pulmonary embolism
(1.3%) (G3/4: 1.1%)a
Deep vein thrombosis
Respiratory, thoracic and mediastinal disorders
Dyspnoea (15.2%)a
(G3/4: 3.5%)a
Cough (15.0%)
(G3/4: 0.5%)d
Oropharyngeal pain
Epistaxis
Rhinorrhoea
Interstitial lung disease (0.2%) (G3/4: 0.1%)
Gastrointestinal disorders
Nausea (35.7%)
(G3/4: 1.1%)d
Constipation (22.3%)
(G3/4: 0.7%)d
Diarrhoea (18.7%)
(G3/4: 0.8%)
Vomiting (18.1%)
(G3/4: 1.0%)
Abdominal pain
Stomatitis (11.1%)
(G3/4: 1.0%)d
Dry mouth
Dyspepsia (6.5%)
(G3/4: 0.3%)d
Gastrooesophageal reflux disease
Abdominal distension
Mouth ulceration Pancreatitis
Hepatobiliary disorders
Aspartate aminotransferase increased (7.7%)
(G3/4: 1.4%)d
Alanine aminotransferase increased (7.6%)
(G3/4: 1.9%)d
Gamma glutamyl transferase increased (1.7%) (G3/4: 0.9%)d
Hyperbilirubinaemia
(1.4%) (G3/4: 0.4%)
Hepatotoxicity
(0.8%) (G3/4: 0.6%)
Skin and subcutaneous tissue disorders
Alopecia
Rash (4.9%)
(G3/4: 0.1%)
Pruritus (3.9%)
(G3/4: 0.1%)d
Nail disorder
Night sweats
Dry skin
Erythema
Hyperhidrosis
Palmar plantar erythrodysaesthesia (1.0%) (G3/4: 0.1%)d
Angioedema
**Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Musculoskeletal and connective tissue disorders
Arthralgia and myalgia
(20.4%) (G3/4: 1.0%)
Back pain (12.8%)
(G3/4: 1.5%)
Pain in extremity
(10.0%) (G3/4: 0.7%)d
Bone pain (6.7%)
(G3/4: 1.2%)
Muscle spasms
(5.3%) (G3/4: 0.1%)d
Musculoskeletal pain
Musculoskeletal chest pain
Muscular weakness
Renal and urinary disorders
Dysuria
Haematuria
Proteinuria
Renal failure
General disorders and administration site conditions
Fatigue/Asthenia
(53.2%) (G3/4 : 7.7%)
Pyrexia (21.8%)
(G3/4: 0.7%)
Mucosal
Inflammation (6.4%)
(G3/4: 0.9%)d
Peripheral oedema
Pain
Chills
Chest pain
Influenza like illness
Investigations
Weight decreased
(11.4%) (G3/4: 0.4%)d
a Includes Grade 5 events.
b From spontaneous reporting
c Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy
d No Grade 4 events
* Rare
** Frequency not known
Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Description of selected adverse reactions
Neutropenia
The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (< 0.5 x 109/l) was 8 days.
Neutrophil counts of < 0.5 x 109/l that lasted for more than 7 days occurred in 13% of breast cancer patients treated with eribulin in the EMBRACE study.
Neutropenia was reported as a Treatment Emergent Adverse Event (TEAE) in 151/404 (37.4% for all grades) in the sarcoma population, compared with 902/1559 (57.9% for all grades) in the breast cancer population. The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively. The median duration of treatment was 12.0 weeks for sarcoma patients and 15.9 weeks for breast cancer patients.
Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported. Out of 1963 breast cancer and soft tissue sarcoma patients who received eribulin at the recommended dose in clinical trials there was one fatal event each of neutropenic sepsis (0.1%) and febrile neutropenia (0.1%). In addition, there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%). Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines. 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively). In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
Disseminated intravascular coagulation
Cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.
Peripheral neuropathy
In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%). The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles). Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy. The median time to Grade 2 peripheral neuropathy was 18.4 weeks.
Development of Grade 3 or 4 peripheral neuropathy occurred in 7.4% of breast cancer patients and 3.5% of sarcoma patients. In clinical trials, patients with pre-existing neuropathy were as likely to develop new or worsening symptoms as those who entered the study without the condition. In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
Hepatotoxicity
In some patients with normal/abnormal liver enzymes prior treatment with eribulin, increased levels of liver enzymes have been reported with initiation of eribulin treatment. Such elevations appeared to have occurred early with eribulin treatment in cycle 1 – 2 for the majority of these patients and whilst thought likely to be a phenomenon of adaptation to eribulin treatment by the liver and not a sign of significant liver toxicity in most patients, hepatotoxicity has also been reported.
Special populations
Elderly population
Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age. In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age. The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age. No dose adjustments are recommended for the elderly population.
Patients with hepatic impairment
Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Although data are limited, patients with bilirubin > 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia (see also sections 4.2 and 5.2).
Paediatric population
Three open-label studies, Studies 113, 213 and 223, were conducted in paediatric patients with refractory or recurrent solid tumours and lymphomas, but excluding central nervous system (CNS) tumours (see section 5.1).
The safety of eribulin monotherapy was evaluated in 43 paediatric patients who received up to 1.58 mg/m2 on Days 1 and 8 of a 21-day cycle (Studies 113 and 223). The safety of eribulin in combination with irinotecan was also evaluated in 40 paediatric patients who received eribulin 1.23 mg/m2 on Days 1 and 8 and irinotecan 20 or 40 mg/m2 on Days 1 to 5 of a 21-day cycle, or 100 or 125 mg/m2 on Days 1 and 8 of a 21-day cycle (Study 213).
In Study 113 (Phase 1), the most frequently reported adverse drug reactions were white blood cell count decreased, lymphocyte count decreased, anaemia and neutrophil count decreased.
In Study 213 (Phase 1/2), the most frequently reported adverse drug reactions were neutropenia (Phase 1) and diarrhoea and neutrophil count decreased (Phase 2).
In Study 223 (Phase 2), the most frequently reported adverse drug reactions were neutrophil count decreased, anaemia, and white blood cell count decreased.
The safety profile of eribulin as monotherapy or in combination with irinotecan hydrochloride in this paediatric population was consistent with the known safety profile of either study drug in the adult population.
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
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.
Ask anything about Eribulin 0.44 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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