Pronunciation:

er-i-BUE-lin MES-i-late

Brand Names:

• Halaven

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Eribulin

Uses of This Medicine:

Eribulin injection is used to treat metastatic (cancer that has already spread to other parts of the body) breast cancer in patients who have already received other types of cancer medicines. Eribulin injection is also used to treat metastatic liposarcoma or liposarcoma that cannot be removed with surgery in patients who have received other types of cancer medicines.

Eribulin belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other side effects may occur. Some of these may be serious and must be reported to your doctor right away. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

Before you begin treatment with eribulin, you and your doctor should talk about the benefits of this medicine as well as the risks.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of eribulin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eribulin injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Amiodarone
• Amisulpride
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Atazanavir
• Buprenorphine
• Buserelin
• Ceritinib
• Chloroquine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Domperidone
• Donepezil
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Trazodone
• Triclabendazole
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (eg, cytopenia, neutropenia) or
• Congestive heart failure or
• Heart rhythm problems (eg, arrhythmias, QT prolongation) or
• Mineral imbalance (eg, low magnesium or potassium in the blood) or
• Nerve problems (eg, peripheral neuropathy)—Use with caution. May make these conditions worse. or

• Heart rhythm problem (eg, congenital long QT syndrome)—Eribulin injection should not be given in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. You may require a lower dose of this medicine. Talk with your doctor if you have concerns about this.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is usually given on Day 1 and Day 8 of a 21-day cycle of treatment. This 2-day treatment is given again every 21 days until your body responds to the medicine or you and your doctor decide to stop the treatment. Each treatment usually takes about 2 to 5 minutes.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for at least 2 weeks after your final dose to keep from getting pregnant. Male patients should also use effective form of birth control during and for 3.5 months after treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Eribulin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

body aches or pain

burning, numbness, tingling, or painful sensations

chills

convulsions

cough

decreased urine

decreased weight

difficult or labored breathing

difficult, burning, or painful urination

dry mouth

ear congestion

fever

frequent urge to urinate

headache

increased thirst

irregular heartbeat

loss of appetite

loss of voice

lower back or side pain

mood changes

muscle pain or cramps

nasal congestion

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pale skin

rapid weight gain

runny nose

sneezing

sore throat

tightness in the chest

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness in the arms, hands, legs, or feet

Incidence not known

Fainting

irregular heartbeat, recurrent

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

back pain

belching

bone pain

change in taste

cracked lips

depression

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

difficulty with swallowing

dizziness

hair loss or thinning of the hair

heartburn

indigestion

lack or loss of strength

loss of taste

muscle spasm or weakness

muscle stiffness

pain in the arms or legs

pain in the joints

rash

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach discomfort, upset, or pain

swelling or inflammation of the mouth

trouble sleeping

watering of the eyes

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.