0.44 mg / ml injection solution
Eribulin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects , talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What HALAVEN is and what it is used for
2. What you need to know before you use HALAVEN
3. How to use HALAVEN
4. Possible side effects
5. How to store HALAVEN
6. Contents of the packaging and other information

1. What HALAVEN is and what it is used for

HALAVEN is a cancer drug that works by preventing the growth and spread of cancer cells.

HALAVEN is used in adults to treat locally advanced or metastatic breast cancer (breast cancer that has spread outside the original tumor ) when at least one other treatment has been tried but lost its effect.

HALAVEN is also used for adults who have advanced or metastatic liposarcoma (a type of cancer that occurs in adipose tissue) when other treatments have been tried but lost their effect.

2. What you need to know before using HALAVEN

Do not use HALAVEN

  • 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 cautions

Talk to your doctor or nurse before using HALAVEN:

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

If any of the above apply to you, talk to your doctor, as treatment may need to be stopped or the dose reduced.

Children and young people

HALAVEN is not recommended for children under 18 with sarcoma as it is still unknown how the drug works in this age group.

Other medicines and HALAVEN

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

HALAVEN can cause serious birth defects and should not be used if you are pregnant unless it is absolutely necessary, and then after careful consideration of the risks to you and your baby. It can also cause persistent future fertility problems in men taking the drug and they should therefore discuss this with their doctor before starting treatment. Women of childbearing potential should use an effective method of contraception during and up to three months after stopping treatment with HALAVEN.

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

Driving and using machines

HALAVEN can 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 small amounts of ethanol (alcohol)

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

3. How to use HALAVEN

HALAVEN is given by qualified healthcare professionals as an injection into a blood vessel for 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters, or m 2 ), which is calculated from your height and weight. The usual dose of HALAVEN is 1.23 mg / m 2, but it may need to be adjusted by your doctor based on your blood test results or other factors. It is recommended that a saline solution be flushed into the vein after injection one with HALAVEN to ensure that you have received the full dose one.

How often should you be treated with HALAVEN?

HALAVEN is usually given on days 1 and 8 of each 21-day cycle. Your doctor will decide how many treatment cycles you will need. Depending on your blood test results, your doctor may need to postpone treatment until your blood tests return to normal. The doctor can then also decide to reduce the dose one.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using HALAVEN and seek medical attention immediately if you get any of the following serious symptoms:

  • fever with palpitations, rapid, shallow breathing, cold, pale, sticky or flammable skin and / or confusion. This can be a sign of a condition called sepsis – a severe and severe reaction to an infection . Blood poisoning is less common (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. This may be a sign of a less common allergic reaction (may affect up to 1 in 100 people).
  • severe skin rash with blistering on the skin, in the mouth, in the eyes and on the 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 user in 10) are:

  • decreased number of white blood cells or red blood cells
  • fatigue or weakness
  • nausea, vomiting, constipation, diarrhea
  • numbness, tingling or tingling
  • fever
  • lost appetite, weight loss
  • difficulty breathing, cough
  • pain in joints, muscles and back
  • headache
  • hair loss

Common side effects (may affect up to 1 in 10 people) are:

  • decreased platelet count (which can lead to bruising and if you cut or injure yourself it may take longer than usual for the bleeding to stop)
  • infection with fever, pneumonia , chills
  • fast heart rate, hot flashes
  • fraud, dizziness
  • increased tear production, conjunctivitis ( redness and tenderness of the whites of the eyes), nosebleeds
  • dehydration, dry mouth , cold sores, cold sores, stomach upset, heartburn, abdominal pain or swelling in the abdomen
  • swelling of the soft tissues, pain (especially pain in the chest, back and skeleton), muscle cramps or muscle weakness
  • infection in your mouth, airways and urinary tract, pain when urinating
  • sore throat, sore or runny nose, flu- like symptoms, sore throat
  • abnormal liver function values, altered levels of sugar, bilirubin , phosphates , potassium , magnesium or calcium in the blood
  • insomnia, depression, altered taste experience
  • 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 numb hands and feet

Uncommon side effects (reported in less than 1 in 100 patients) are:

  • blood clots
  • abnormal liver function values ​​(hepatotoxicity)
  • kidney failure , blood or protein in the urine
  • widespread pneumonia that can cause scarring
  • inflammation of the pancreas
  • cold sores

Rare side effects (may affect more than 1 user in 1,000) are:

  • a serious blood clot disease that leads to 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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store 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 expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin. Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.
  • The other ingredients are ethanol , water for injections and possibly hydrochloric acid and sodium hydroxide in very small amounts.

What the medicine looks like and contents of the pack

HALAVEN is a clear and colorless aqueous solution for injection provided in glass vials containing 2 ml or 3 ml solution. Each carton contains either 1 or 6 vials.

Marketing Authorization Holder and Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

email: medinfo_de@eisai.net

Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Sweden

Eisai AB

Tel: + 46 (0) 8 501 01 600

Muhammad Nadeem

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