Eribulin Baxter 0.44 mg/mL solution for injection

• Keep this leaflet. 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 includes any possible side effects not listed in this leaflet. See section 4.

1. What Eribulin Baxter is and what it is used for
2. What you need to know before you use Eribulin Baxter
3. How to use Eribulin Baxter
4. Possible side effects
5. How to store Eribulin Baxter
6. Contents of the pack and other information

• 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.

Talk to your doctor or nurse before using Eribulin Baxter:

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

If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.

Do not give this medicine to children between the ages of 0 to 18 years because it does not work.

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

Eribulin Baxter may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraception during and up to 3 months after treatment with Eribulin Baxter.

Eribulin Baxter must not be used during breast-feeding because of the possibility of risk to the child.

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

This medicine contains 78.9 mg (0.1 mL) of ethanol anhydrous in each vial. The amount in 2 mL of this medicine is equivalent to 2 mL beer or less than 1 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially `sodium-free'.

Eribulin Baxter is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.

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.

If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
• The other ingredients are anhydrous ethanol and water for injections, with concentrated hydrochloric acid (for pH-adjustment), and sodium hydroxide (for pH-adjustment) possibly present in very small amounts.

Eribulin Baxter is a clear, colourless aqueous solution for injection essentially free from visible particles provided in a glass vial containing 2 mL of solution. Each carton contains 1 vial.