CLOFARABINE NEON HEALTHCARE 1 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

1. what clofarabine is and what it is used for

Clofarabine contains the active substance clofarabine. Clofarabine is one of a family of medicines called anticancer medicines. It works by hindering the growth of abnormal white blood cells, and eventually kills them. It works best against cells which are multiplying quickly – such as cancer cells.

Clofarabine is used to treat children (a 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL ) when previous treatments have not worked or have stopped working. Acute lymphoblastic leukaemia is caused by abnormal growth ofsome types of white blood cells.

2. what you need to know before you use clofarabine

Do not use Clofarabine:

• – ifyou are allergic to clofarabine or any ofthe other ingredients ofthis medicine (listed in section 6);

• - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below);

• - if you have severe kidney or liver problems.

Tell your doctor if any of these conditions apply to you. If you are the parent of a child who is being treated with Clofarabine, tell the doctor if any of them apply to your child

Warnings and precautions

Talk to your doctor or pharmacist before using Clofarabine.

Tell your doctor if any of these apply to you. Clofarabine may not be suitable for you:

• - if you have suffered a severe reaction after previously using this medicine;

• - if you have kidney disease, or used to have it;

• - if you have liver disease, or used to have it;

• - if you have heart disease, or used to have it.

Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment:

• – if you get a fever or high temperature – because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections;

• – ifyou have breathing difficulties, rapid breathing, or breathlessness;

• – if you feel a change in your heart rate;

• – if you suffer from dizziness (light-headedness) or fainting – it may be a symptom of low blood pressure;

• – if you feel sick or have diarrhoea (loose bowels);

• – ifyour urine is darker than usual – it is important to drink plenty ofwaterto avoid dehydration;

• – if you get a rash with blisters or mouth ulcers;

• – ifyou lose your appetite, have nausea (feeling sick), vomiting, diarrhoea, dark-coloured urine and light-coloured stools, stomach pain, jaundice (yellowing ofthe skin and eyes), or ifyou feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure);

• – ifyou pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss ofappetite and / orweakness (these may be signs of acute kidney failure / kidney failure).

If you are the parent of a child who is being treated with Clofarabine, tell the doctor if any of the above conditions apply to your child.

During treatment with Clofarabine your doctor will carry out regular blood tests and other tests to monitor your health. Because of the way this medicine works, it will affect your blood and other organs.

Talk to your doctor about contraception. Young men and women must use effective contraception during and after treatment. See the section “Pregnancy and breast-feeding” below. Clofarabine may harm both male and female reproductive organs. Ask your doctor to explain what can be done to protect you or allow you to have a family.

Other medicines and Clofarabine

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

Tell your doctor ifyou are using or have recently used:

• – medicines for heart disease;

• – any medicine that changes your blood pressure;

• – medicines that affect your liver or kidneys;

• – any other medicines including those obtained without a prescription.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Clofarabine should not be used during pregnancy unless clearly necessary. Women who are able to get pregnant: you must use effective contraception during treatment with clofarabine. Clofarabine may cause harm to unborn babies when used by pregnant women. If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately.

Men must also use effective contraception while they or their partner are treated with clofarabine.

Ifyou are breast-feeding, you must stop breast-feeding before starting the treatment, and must not breast-feed during yourtreatment and within 3 months after completion of your treatment.

Driving and using machines

Do not drive or use any tools or machines ifyou feel dizzy, light-headed or faint.

Clofarabine contains sodium

This medicine contains 70.77 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.54% ofthe recommended maximum daily dietary intake of sodium for an adult. This is equivalent to 3.08 mmol of sodium. The recommended maximum level of intake of 2 g/day sodium in adults should be adjusted downward based on the energy requirements of children relative to those of adults.

3. how to use clofarabine

Yourtreatment with Clofarabine has been prescribed by a qualified doctor experienced in treating leukaemia.

Yourdoctorwill work out the dose that is right for you depending on your height, weight and howwell you are. Before Clofarabine is given to you, it will be diluted in a sodium chloride solution (salt and water). Tell your doctor ifyou are on a controlled sodium diet as it could affect howyou will be given your medicine.

Yourdoctorwill give you Clofarabine once every day for 5 days. It will be given to you as an infusion through a long thin tube which goes into a vein (a drip), or into a small medical appliance that is inserted under the skin (port-a-cath) ifyou (oryourchild) have one implanted. The infusion will be given over 2 hours. Ifyou (oryour child) weigh less than 20 kg, the infusion time may be longer.

Your doctor will monitor your health and may change your dose depending on your response to the treatment. It is important to drink plenty ofwaterto avoid dehydration.

If you use more Clofarabine than you should

If you think you may have been given too much medicine, tell your doctor straight away.

If you forget to use Clofarabine

Your doctor will tell you when you need to be given this medicine. Ifyou think that you have missed a dose, tell your doctor straight away.

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

4. possible side effects

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

Very common (may affect more than 1 in 10 people):

• – anxiety, headache, fever, tiredness;

• – feeling and being sick, diarrhoea (loose bowels);

• – flushing, itching and inflamed skin, inflammation ofmucus (moist) linings such as the mouth and other areas;

• – you may have more infections than normal because Clofarabine can lower the number of certain types of blood cells in your body;

• – skin rashes which may be itchy, red, painful or peeling skin including palms ofthe hands and soles ofthe feet, orsmall reddish or purple spots underneath the skin.

Common (may affect uptol in10 people):

• – infections ofthe blood, pneumonia, shingles, implant infections, infections ofthe mouth such as thrush and cold sores;

• – changes in blood chemistry, changes in white blood cells;

• – allergic reactions;

• – feeling thirsty and producing darker or less urine than normal, decreased or loss ofappetite, weight loss;

• – agitation, irritability, or restlessness;

• – feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor;

• – hearing problems;

• – water collecting around the heart, fast heartbeat;

• – low blood pressure, lump due to bad bruising;

• – leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties, breathlessnes­s, cough;

• – vomiting blood, stomach ache, pain in the bottom;

• – bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining;

• – yellowing ofthe skin and eyes (also called jaundice), or other liver disorders;

• – bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems;

• – pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, orjoints;

• – blood in urine;

• – failure of organs, pain, increased muscle tension, water retention and swelling in parts ofthe body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal;

• – clofarabine may affect the levels of certain substances in the blood. Your doctor will carry out regular blood tests to check whether your body is working properly;

• – liverdamage(li­verfailure);

• – little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure).

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

• – inflammation ofthe liver (hepatitis).

Reporting of side effects

Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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 ofthis medicine.

5. how to store clofarabine

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

Do not use this medicine afterthe expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Once prepared and diluted, Clofarabine should be used straight away or within 24 hours if stored in a refrigerator (at 2°C to 8°C).

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.

6. Contents ofthe pack and other information

What Clofarabine contains

• – The active substance is clofarabine. Each ml contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg ofclofarabine.

• – The other ingredients are sodium chloride and water for injections

What Clofarabine looks like and contents of the pack

A clear, colourless solution, free from visible particles, filled in 20 ml glass (type I) vial with grey bromobutyl rubberstopperand aluminium flip offdark blue seal.

Each pack contains 1 single use vial.

Marketing Authorisation Holder

Neon Healthcare Ltd, Mill Studio Business Centre, Crane Mead, Ware, SG12 9PY, UK

Manufacturer

Wave Pharma Ltd, 4th Floor, Cavendish House,

369 Burnt Oak, Broadway, Edgware, HA8 5AW, UK or

DREHM Pharma GmbH

Hietzinger, Hauptstrasse 37/2, 1130, Vienna, Austria

This leaflet was last revised in 01/2021.