What is it and how is it used?
LITAK contains the active substance cladribine. Cladribine is a cytostatic agent. It affects the growth of malignant (cancerous) white blood cells which play a role in hairy cell leukaemia. LITAK is used to treat this disease.
What do you have to consider before using it?
Do not use LITAK
Take special care with LITAK
Tell your doctor if you have or have had:
Before and during treatment with LITAK, you will have regular blood tests to check whether it is safe for you to continue with your treatment. Your doctor may decide that you should receive blood transfusions to improve your level of blood cells. In addition, the proper function of your liver and your kidneys will be checked.
If you want to father a child, please tell your doctor before treatment with LITAK is started. You should not father a child during treatment and up to 6 months after treatment with LITAK. Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are using any medicines containing:
You must not use LITAK with other medicines that affect the production of blood cells in the bone marrow (myelosuppression).
Pregnancy and breast-feeding
Your must not use LITAK if you are pregnant. You must take adequate contraceptive precautions during therapy and for at least six months after your last LITAK dose. If pregnancy occurs during your treatment, you must immediately inform your doctor.
You must not breast-feed while you are treated with LITAK and for at least six months after your last LITAK dose.
Driving and using machines
LITAK has a major effect on the ability to drive and use machines. If you feel drowsy, which may occur due to a low number of red blood cells caused by LITAK treatment, or dizzy, you should not drive or use machines.
How is it used?
Always use LITAK as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will calculate your dose according to your body weight and explain the treatment schedule in detail. The recommended daily dose is 0.14 mg per kg body weight for five consecutive days (single treatment course).
LITAK has to be injected under your skin (subcutaneous injection), at about the same time each day. If you are injecting LITAK yourself, first you must receive adequate training by your doctor or nurse. You will find detailed instructions for injection at the end of this leaflet.
You may also receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.
If you use more LITAK than you should
In case you inject an incorrect dose, tell your doctor immediately.
If you forget to use LITAK
Do not inject a double dose to make up for a forgotten dose. In case you miss an injection of a dose, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, LITAK can have side effects, although not everybody gets them.
Tell your doctor immediately if you have any of the following during or after treatment with LITAK:
Repeated occurrence of malignant (cancerous) disease cannot be excluded. This means that the risk that you develop a malignant disease in the future is slightly higher than for healthy people. This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including LITAK.
Side effects may occur with certain frequencies, which are defined as follows:
Very common side effects
Infections.
Fever.
Low numbers of certain white blood cells (neutrophils and lymphocytes) and platelets in blood tests.
Low number of red blood cells, which may result in anaemia, with symptoms such as tiredness and drowsiness.
Reduced function of your body’s immune system.
Headache, dizziness.
Abnormal breath sounds, abnormal chest sounds, cough.
Feeling sick, vomiting, constipation and diarrhoea.
Skin eruption (rash), swelling, redness as well as soreness around the site of injection, sweating. Skin reactions are mostly mild to moderate and usually resolve within a few days. Tiredness, chills, decreased appetite.
Weakness.
Common side effects
Repeated occurrence of malignant (cancerous) disease.
Low number of platelets, which can cause unusual bleeding (for example nose or skin bleeds). Sleeplessness, anxiety.
Increased heart rate, abnormal heart sound, low blood pressure, decreased blood supply to the heart muscle.
Shortness of breath, swelling in lung tissue due to infection, inflammation of mouth and tongue. Abdominal pain and presence of excessive amount of gas in the stomach or bowels, mostly mild increases in liver laboratory values (bilirubin, transaminases) which will return to normal values once treatment is over.
Itching, itching skin eruption (urticaria), redness of the skin and skin pain.
Swelling in tissues (oedema), not feeling well, pain (muscle pain, joint pain, and bone pain).
Uncommon side effects
Anaemia caused by destruction of red blood cells.
Sleepiness, numbness and tingling of the skin, feebleness, inactivity, disorder of peripheral nerves, confusion, impaired ability to coordinate movements.
Eye inflammation.
Sore throat.
Inflammation of a vein.
Severe weight loss.
Rare side effects
Reduced liver function.
Reduced kidney function.
Complications caused by cancer treatment due to break-down of cancer cells. Rejection response to blood transfusions.
Increased number of certain white blood cells (eosinophils).
Stroke.
Disturbances in speech and swallowing.
Heart failure.
Abnormal heart rhythm.
Inability of the heart to maintain adequate blood circulation.
Obstruction of the bowels.
Serious allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).
Very rare side effects
Depression, epileptic attack.
Swelling of the eyelid.
Blood clot in the lung.
Inflammation of the gallbladder.
Reduced function of organs due to high amounts of a specific substance produced by the body (a glycoprotein).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Store in a refrigerator (2°C-8°C). Do not freeze.
Do not use LITAK after the expiry date which is stated on the vial label and the outer carton after EXP. The expiry date refers to the last day of that month.
From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not use LITAK if you notice that the vial is damaged or that the solution is not clear or contains any particles.
Any unused product or waste material should be disposed of in accordance with local requirements.
