PATIENT INFORMATION LEAFLET

Cytarabine 20 mg/ml

Cytarabine 100 mg/ml

Solution for Injection

This leaflet is a summary of information about Cytarabine. Please read it carefully before treatment begins. The leaflet cannot tell you everything about this medicine. If there is anything you do not understand or if you have any questions, ask your doctor, nurse or pharmacist (chemist). Keep this leaflet; you may want to read it again.

What is in Cytarabine?

The name of this medicine is Cytarabine and is a solution available in two strengths 20 mg/ml or 100 mg/ml. It contains a substance (active ingredient) called Cytarabine along with other inactive ingredients, hydrochloric acid, sodium hydroxide, nitrogen and water for injections. Cytarabine 20 mg/ml also contains sodium chloride. Cytarabine is supplied in plastic vials containing 100 mg (5 ml), 500 mg (25 ml) 1000 mg (10 ml) or 2000 mg (20 ml) Cytarabine.

How does Cytarabine work?

Cytarabine belongs to the group of medicines described as cytotoxic. It interferes with the growth of certain cells in your body and eventually kills them. It works best against cells, which are multiplying quickly like cancer cells.

What is Cytarabine for?

It is used to treat acute leukaemias (cancer of blood where you have too many white blood cells). It also acts to depress your immune system. The active ingredient Cytarabine interferes with the growth of cancer cells, which are eventually destroyed.

Cytarabine is used for the induction and maintenance of remission.

Remission induction is an intensive treatment to force leukaemia into retreat. When it works, the balance of cells in your blood becomes more normal and your health improves. This relatively healthy spell is called a remission.

Maintenance therapy is a milder treatment to make your remission last as long as possible. Quite low doses of Cytarabine are used to keep the leukaemia under control and stop it flaring up again.

If feeling unwell following treatment with Cytarabine you should avoid driving or using industrial machinery.

Before taking this medicine - your Doctor should know:

Your doctor will ask you questions before giving you or your child this medicine to make sure that it is suitable. If you do not understand any of the questions, ask your doctor to explain.

How is Cytarabine used?

You will receive your Cytarabine by infusion ("drip") or by an injection. Your doctor will decide the best way for you to have your treatment.

The dose of Cytarabine will be decided by your doctor based on your condition being treated and bodyweight and ability to tolerate Cytarabine.

For remission induction your doctor may decide to give you either continuous or intermittent treatment. Continuous treatment can be given in two ways.

Rapid Injection: The doctor will start by giving you 2 mg Cytarabine for each kg of your bodyweight each day for 10 days. If considered necessary by the doctor the dose may be increased to 4 mg for each kg of bodyweight. The effect of your treatment will be monitored daily by samples of blood being taken and examined.

Infusion: The doctor may give you an infusion of drug. The dosage usually given is 0.5-1.0 mg Cytarabine for each kg of bodyweight per day over 10 days. If considered necessary by your doctor this dose may be increased to 2 mg per kg bodyweight/day.

In Intermittent Treatment you will be given 3-5 mg Cytarabine for each kg of your bodyweight intravenously on each of 5 consecutive days. After a 2 to 9 day rest period you will be given a further course, which continues until your doctor feels it is appropriate to stop.

Maintenance Therapy: Remissions which have been induced by Cytarabine or by other drugs may be maintained by you receiving a dose of 1 mg/kg of your bodyweight once or twice a week by infusion ("drip") or injection.

If your child is receiving Cytarabine the doctor will decide what dose is needed and how to give it. If you are concerned about your child's treatment discuss this with the doctor.

Cytarabine is sometimes given together with certain other medicines. If you are receiving a combination of medicines it is important that you receive each at the proper time. If you are taking some of these medicines by mouth please ask your doctor, nurse or hospital pharmacist to help plan a way to take them at the right time.

This medicine often makes you feel and be sick (nausea and vomiting). Because it is very important that you continue to receive the medicine even if you begin to feel ill, tell your doctor, nurse, or pharmacist, as they may be able to find ways to lessen these effects.

What side effects does Cytarabine have?

All cytotoxic drugs have unwanted side effects and these can vary from patient to patient.

You may notice the following:

• Feeling sick, vomiting or diarrhoea.
• Headache or feeling dizzy
• Feeling hot and feverish
• Appearance of sores in the mouth, lips, or on the anus.
• A yellowing of the skin or the whites of the eyes.
• Pain and numbness in joints, fingers, toes or face.
• Black tarry stools.
• Difficulty or pain when passing urine. Blood in your urine.
• Cytarabine may reduce the number of cells in your blood. If you get a sore throat or increased temperature after treatment or notice unusual bleeding or bruising then tell your doctor.
• Loss of appetite, feeling very tired and weak.
• Chest pain, shortness of breath
• Feeling of pins and needles.
• A rash or ulceration on your skin, itching or increased freckles.
• You may get an infection, including infection or inflammation at the site of your injection.
• pneumonia or blood infection.
• Inflammation of the gullet, causing heartburn and nausea.
• bleeding of the skin, gums or nose.
• Impaired kidney function
• Conjunctivitis
• Severe allergic reaction

Sometimes the following side-effects can happen together 6-12 hours after receiving Cytarabine. Feeling generally unwell with a high temperature, pain in bone, muscle and sometimes the chest, blistery rash, sore eyes. This is called "Cytarabine Syndrome" and can be treated.

Some people develop pancreatitis (inflammation of pancreas - a gland that lies behind the stomach) when they start treatment with Cytarabine. Pancreatitis can cause sudden attacks of severe pain in the upper abdomen, often accompanied by feeling sick or vomiting. Tell your doctor if this happens to you.

Because of the way Cytarabine acts, there will be effects on your blood and your doctor will take frequent blood samples. Depending on the result of the tests carried out, your doctor may decide to change the dose of Cytarabine received or he may decide to change to a different type of drug. This medicine may cause a temporary loss of hair in some people. After treatment with Cytarabine has ended, normal hair growth should return.

After treatment with Cytarabine is stopped, it may still produce some side-effects that need attention. During this period of time please inform your doctor if you notice any of the following:-

Black, tarry stools; blood in urine; pains in the joints or limbs; difficult or painful urination; skin rash; or unusual bleeding or bruising.

If you suffer from these or any side-effect not listed above, please inform your doctor or the nursing staff immediately.

Looking after your medicine

Hospital staff will store your medicine safely. Vials of Cytarabine need to be kept in their cartons between 15°C and 25°C and they mustn't be kept in a fridge or freezer. Staff will check the "use-by" date on the pack before it is used. Once opened, the medicine must be used immediately.