HALAVEN 0.44 mg/mL Injectable Solution

2. What you need to know before you use HALAVEN

Do not use HALAVEN:

• if you are allergic to eribulin mesylate or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.

Warnings and precautions

Tell your doctor or nurse before you start using HALAVEN

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

If you are affected by any of these, tell your doctor as they may want to stop your treatment or reduce your dose.

Children and adolescents

Do not give this medicine to children from 0 to 18 years old as it is not effective in them.

Other medicines and HALAVEN

Tell your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy, breast-feeding, and fertility

HALAVEN may cause serious birth defects and should not be used during pregnancy unless clearly necessary after careful consideration of the risks to you and the baby. It may also cause permanent fertility problems in men in the future if they take it, and they should discuss this with their 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 the end of treatment.

HALAVEN should not be used during breast-feeding due to the potential risk to the baby.

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

Driving and using machines

HALAVEN may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or use machines if you feel tired or dizzy.

HALAVEN contains ethanol (alcohol)

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

3. How to use HALAVEN

A healthcare professional will give you HALAVEN as an injection into a vein over a period of 2 to 5 minutes. The dose you receive will be 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, but your doctor may adjust it based on the results of blood tests or other factors. After administration of HALAVEN, it is recommended to flush the vein with a saline solution to ensure that the full dose of HALAVEN is administered.

Frequency of administration of HALAVEN

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

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

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 HALAVEN and go to your doctor immediately:

• Fever, with a very fast heart rate, rapid and shallow breathing, cool, 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 uncommon (may affect up to 1 in 100 people) and can be life-threatening and lead to death.
• Difficulty breathing or swelling of the face, mouth, tongue, or throat. These may be signs of a rare allergic reaction (may affect up to 1 in 100 people).
• Severe skin rash 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 not known, but it can be potentially fatal.

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
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or pinching
• 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 can lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Fast heart rate, hot flushes
• Dizziness, lightheadedness
• Increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, thrush, indigestion, heartburn, stomach pain, or bloating
• Swelling of soft tissues, pain (especially chest, back, and bone pain), muscle spasms, or weakness
• Infections of the mouth, respiratory tract, and urinary tract, pain when urinating
• Sore throat, nose pain, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormal liver function tests, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
• Insomnia, depression, altered sense of taste
• Rash, itching, nail problems, dryness, or redness of the skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Shingles

• Swelling of the skin and numbness in hands and feet

Uncommon side effects (may affect up to 1 in 100 people) are:

• Blood clots
• Abnormal liver function tests (hepatotoxicity)

• Kidney failure, blood, or protein in the urine
• Widespread lung inflammation that can lead to scarring
• Pancreatitis
• Ulcers in the mouth

Rare side effects (may affect up to 1 in 1,000 people) are:

• A severe blood clotting disorder that can lead to widespread blood clots and internal bleeding

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HALAVEN

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 vial after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

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

If HALAVEN as an undiluted solution has been transferred to a syringe, it should be stored between 15°C and 25°C in 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 disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of HALAVEN

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

Appearance and pack of the product

HALAVEN is a clear and colorless aqueous solution for injection, which comes in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.

Marketing authorisation holder

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am MainGermany

e-mail: [email protected]

Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am MainGermany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.