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

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Package leaflet: Information for the user

Clofarabine 1 mg/ml concentrate for solution for infusion

clofarabine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Clofarabine 1 mg/ml concentrate for solution for infusion is and what it is used for

• 2. What you need to know before you use Clofarabine 1 mg/ml concentrate for solution for infusion

• 3. How to use Clofarabine 1 mg/ml concentrate for solution for infusion

• 4. Possible side effects

• 5. How to store Clofarabine 1mg/ml concentrate for solution for infusion

• 6. Contents of the pack and other information

1. what clofarbine 1 mg/ml concentrate for solution for infusion is and what it is used for

Clofarabine 1 mg/ml concentrate for solution for infusion contains the active ingredient 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 1 mg/ml concentrate for solution for infusion is used to treat children (> 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 of some types of white blood cells.

2. what you need to know before you use clofarbine 1 mg/ml concentrate for solution for infusion

Do not use Clofarabine:

• if you are allergic to clofarabine or any of the other ingredients of this 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 your doctor if any of them apply to your child.

Warnings and precautions

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;

• – if you 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);

• – if your urine is darker than usual – it is important to drink plenty of water to avoid dehydration;

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

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

• – if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (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 ‘Pregnacy 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 if you 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:

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.

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

Driving and using machines

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

Clofarabine contains sodium

This medicine contains 70.77 mg sodium (main component of cooking/table salt) in each 20 ml vial. This is equivalent to 3.54 % of the recommended maximum daily dietary intake of sodium for an adult.

3. how to use clofarbine 1 mg/ml concentrate for solution for infusion

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

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

Your doctor will 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) if you (or your child) have one implanted. The infusion will be given over 2 hours. If you (or your 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 of water to 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.

A/s: 210 × 360 mm ■ Black

If you forget to use Clofarabine

Your doctor will tell you when you need to be given this medicine. If you 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.

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 of mucus (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 of the hands and soles of the feet, or small reddish or purple spots underneath the skin.

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

• – infections of the blood, pneumonia, shingles, implant infections, infections of the 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 of appetite, 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 of the 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, or joints;

• – blood in urine;

• – failure of organs, pain, increased muscle tension, water retention and swelling in parts of the 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;

• – liver damage (liver failure);

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

Uncommon (may affect up to 1 in 100 people)

• – inflammation of the liver (hepatitis).

6. contents of the pack and other information

What Clofarabine 1mg/ml concentrate for solution for infusion contains:

The active substance is clofarabine. Each ml contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. The other ingredients are sodium chloride and Water for injections.

What Clofarabine 1mg/ml concentrate for solution for infusion looks like and contents of the pack:

Clofarabine is a concentrate for solution for infusion. It is a clear, colorless solution that is prepared and diluted before it is used. It is filled in type-I tubular clear glass vials with grey bromobutyl rubber stoppers and sealed with aluminium seals having polypropylene disc. It is supplied in 20 ml glass vials. The vials contain 20 mg of clofarabine and are packaged in a carton. Each carton contains 1 or 4 vials, but not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000

Malta

or

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

or

Generis Farmaceutica, S.A., Rua Joao de Deus, n.o 19, Venda Nova, 2700–487 Amadora, Portugal

The reference medicinal product containing clofarabine has been authorised under “exceptional circumstances”. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

This leaflet was last revised in 03/2021.

5. How to store Clofarbine 1 mg/ml concentrate for solution for infusion

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 vial label and box after EXP. The expiry date refers to the last day of that month.

Store below 30° C.

Once prepared and diluted, Clofarabine 1mg/ml concentrate for solution for infusion should be used straight away or within 24 hours if stored in a refrigerator (at 2°C to 8°C).