HALAVEN 0.44 mg/ml solution for injection

eribulin

HALAVEN 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.

HALAVEN 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 m²) which is calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m², but this may be adjusted by your doctor based on your blood test results or other factors. To ensure that the whole dose of HALAVEN is given it is recommended that a saline solution is flushed into the vein after HALAVEN is 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 HALAVEN 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.

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.

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

If HALAVEN 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 4 hours, or at 2- 8°C for no longer than 24 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.