Prescribing Information for the User

HALAVEN 0.44 mg/mL Injectable Solution

eribulin

Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prescribing information. See Section 4.

Contents of the package and additional information

HALAVEN contains the active ingredient eribulina and is a cancer medication that works by slowing the growth and spread of cancer cells.

It is used for the treatment of adult patients with locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumor) when at least one other treatment has stopped working.

It is also used for the treatment of adult patients with advanced or metastatic liposarcoma (a type of cancer that appears in fatty tissue) when a previous treatment has stopped working.

Do not use HALAVEN:

• if you are allergic to eribulin mesylate or to any of the other components of this medication (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or nurse before starting to use HALAVEN

• if you have liver problems
• if you have a fever or an infection
• if you experience numbness, tingling, pins and needles, sensitivity to touch or muscle weakness
• if you have heart problems

If you are affected by any of the above points, inform your doctor as they may want to suspend your treatment or reduce your dose.

Children and adolescents

Do not administer this medication to children aged 0 to 18 years as it has no effect on them.

Other medications and HALAVEN

Inform your doctor if you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

HALAVEN may cause severe congenital malformations and should not be used during pregnancy, unless it is clearly necessary after carefully considering all the risks for you and the baby. It may also cause permanent fertility problems in the future in men who take it, and you should consult your doctor before starting treatment. Women of childbearing age should use highly effective contraceptive methods during treatment with HALAVEN and for up to 7 months after completing treatment.

HALAVEN should not be used during breastfeeding due to the possible risk to the child.

Men with partners of childbearing age should not leave them pregnant while receiving HALAVEN. They should use effective contraceptive methods during treatment with HALAVEN and for up to 4 months after completing treatment.

Driving and operating machinery

HALAVEN may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you are feeling tired or dizzy.

HALAVEN contains ethanol (alcohol)

This medication contains small amounts of ethanol (alcohol), less than 100mg per vial.

A qualified healthcare professional will administer HALAVEN as an injection into a vein over a period of 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters, or m2) calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After administration of HALAVEN, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of HALAVEN.

HALAVEN Administration Frequency

HALAVEN is usually administered on days 1 and 8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on blood test results, your doctor may need to delay administration of the medication until blood test results return to normal. At that time, your doctor may also decide to reduce the dose you receive.

If you have any other questions about using this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following severe symptoms, stop taking HALAVEN and seek medical attention immediately:

• Fever, with very rapid heart rate, rapid and shallow breathing, cold, pale, moist, or mottled skin, and/or confusion. These may be signs of a condition called septicemia, a severe and life-threatening reaction to an infection. Septicemia is rare (can affect up to 1 in 100 people) and may put your life in danger and lead to death.
• Difficulty breathing or swelling of the face, mouth, tongue, or throat. These may be signs of a rare allergic reaction (can affect up to 1 in 100 people).
• Severe skin eruptions with blisters on 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 unknown, but it may be potentially fatal.

Other side effects:

The very common side effects (can affect more than 1 in 10 people) are:

• Decreased white blood cell or red blood cell count
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or pins and needles
• Fever
• Loss of appetite, weight loss
• Difficulty breathing, cough
• Pain in the joints, muscles, and back
• Headache
• Hair loss

The common side effects (can affect up to 1 in 10 people) are:

• Decreased platelet count (which may lead to bruising or delayed bleeding)
• Infection with fever, pneumonia, chills
• Rapid heart rate, hot flashes
• Dizziness, vertigo
• Increased tear production, conjunctivitis (redness and itching of the eye surface), nasal bleeding
• Dehydration, dry mouth, cold sores, oral thrush, indigestion, stomach pain or swelling
• Swelling of soft tissues, pain (specifically chest, back, and bone pain), muscle spasms or weakness
• Infections in the mouth, respiratory tract, and urinary tract, painful urination
• Sore throat, runny nose, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormal liver function test results, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
• Inability to sleep, depression, altered sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including nighttime sweating)
• Tinnitus in the ears
• Clots in the lungs
• Herpes zoster

• Swelling of the skin and numbness in the hands and feet

The rare side effects (can affect up to 1 in 100 people) are:

• Clots in the blood
• Abnormal liver function test results (hepatotoxicity)

• Failure of the kidneys, blood or protein in the urine
• Extensive pulmonary inflammation that may lead to scarring
• Pancreatitis
• Ulcers in the mouth

The rare side effects (can affect up to 1 in 1000 people) are:

• A severe blood clotting disorder that may lead to extensive blood clots and internal bleeding

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directlythrough the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

If HALAVEN is diluted for infusion, the diluted solution must be used immediately. If not used immediately, the diluted solution must be stored between 2°C and 8°C for no more than 72 hours.

If HALAVEN as undiluted solution has been transferred to a syringe, it must be stored between 15°C and 25°C with ambient light for no more than 4 hours, or between 2°C and 8°C for no more than 24 hours.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of HALAVEN

• The active ingredient is eribulin. Each vial of 2 ml contains mesylate of eribulin equivalent to 0.88 mg of eribulin.
• The other components are ethanol and water for injectable preparations, with possible presence in very small amounts of hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the package

HALAVEN is a transparent and colorless injectable aqueous solution that comes in glass vials containing 2 ml of solution. Each box contains 1 or 6 vials.

Marketing Authorization Holder

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am MainGermany

e-mail: [email protected]

Responsible for manufacturing

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am MainGermany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.