(cladribine)

Brand name: Leustat Injection

Active ingredient: cladribine 1 mg/ml

Other ingredients: sodium chloride, phosphoric acid, dibasic sodium phosphate heptahydrate, water for injection.

Product licence holder: Janssen-Cilag Ltd Saunderton, High Wycombe, Buckinghamshire HP14 4HJ.

Manufactured by: IOLAB, PO Box 367, Road 362 Km 0.5, San German, Puerto Rico 00683, USA.

• you know you are allergic to the ingredients of Leustat
• you are pregnant or think you may be pregnant
• you are breastfeeding

Please tell your doctor if you are suffering, or have suffered, from any of the following:

• kidney disease
• liver disease
• diseases of the bone marrow or any blood disorders

You may still be able to use Leustat, but you should discuss this with your doctor first.

Your disease and its treatment may affect your ability to drive. Do not drive without discussing this with your doctor first.

Remember to tell your doctor that you are receiving, or have received, Leustat if you have to visit a hospital or your family doctor for any treatment, or to visit a clinic for a blood test; Leustat may affect the results.

Adults and the elderly: The normal dose is based on your body weight in kilograms and is usually 0.09 mg per kilogram per day. This dose is repeated daily for seven days without a break.

Children: Leustat injection is not recommended for children.

Leustat is normally diluted in 100-500 ml of a 0.9 percent solution of sodium chloride and then given by infusion into a vein (intravenous infusion). Each dose is normally given by continuous infusion over a 24-hour period.

and during your treatment, to check that your liver and kidneys are working properly and to follow the effects of the treatment with Leustat.

Your doctor may decide to delay or discontinue therapy if side effects develop.

Can an overdose of Leustat be given?

Too much (an overdose) of any drug should be avoided. You should inform the doctor or nurse immediately if you think you have been given too much Leustat.

Leustat can reduce the ability of your bone marrow to produce blood cells.

If the production of red blood cells is affected, this can lead to anaemia, which may be very severe.

If the production of white blood cells is affected, this can lead to neutropenia which reduces your body's defences so that you may get an infection. This may require the use of antibiotics.

Leustat can also affect the production of platelets: these are small blood cells important for the proper clotting of blood. A fall in the number of platelets (thrombocytopenia) can lead to easier bruising and bleeding under the skin.

Leustat may affect the kidneys, leading to a decrease in their ability to get rid of waste products from the blood and a decrease in urine production.

Leustat can cause serious nerve damage, including partial or complete paralysis which may not be reversible, but usually only if given in doses higher than those normally recommended.

Other side effects may include:

• fatigue
• fever or chills (these may be the first signs that you have an infection; it is important that you are on the lookout for these symptoms and tell your doctor or nursing staff at once if they occur)
• nausea and vomiting
• skin rash
• headache
• decreased appetite
• general debility
• sweating
• feeling unwell
• constipation
• flatulence and diarrhoea
• pain in the abdomen
• muscular aches and pains
• numbness and tingling usually of the hands and feet
• bruising
• small reddish or purple spots underneath the skin called petechiae
• dizziness
• insomnia
• anxiety
• accumulation of fluid under the skin (oedema)
• an increased pulse rate
• a change in normal breathing and/or heart beat sounds (your doctor will be able to detect these if he listens to your chest with a special device called a stethoscope)
• cough
• shortness of breath
• reactions at the site where the injection is given: redness, itching, swelling, pain, blood clot formation (thrombosis), inflammation of the vein (phlebitis).

When abnormal white blood cells are destroyed in large numbers they can release certain substances into the blood. This may cause the blood levels of these substances to rise, leading to kidney or heart problems. You doctor will be able to detect this from the results of regular blood tests he/she is using to monitor your treatment.

Do not use this product:

Keep out of reach of children

Date of revision of this leaflet: February 1996