Atriance
nelarabine
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Atriance is and what it is used for
What you need to know before you are given Atriance
How Atriance is given
Possible side effects
How to store Atriance
Contents of the pack and other information
Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents,
used in chemotherapy to kill some types of cancer cells.
a type of leukaemia, called T-cell acute lymphoblastic leukaemia. Leukaemia causes an abnormal increase in the number of white blood cells. The abnormal high number of white
blood cells can appear in the blood and other parts of the body. The type of leukaemia relates to the type of white blood cell mainly involved. In this case, its cells are called lymphoblasts.
a type of lymphoma, called T-cell lymphoblastic lymphoma. This lymphoma is caused by a
mass of lymphoblasts, a type of white blood cell.
If you have any questions about your illness, talk to your doctor
if you (or your child, if he/she is being treated) are allergic to nelarabine or any of the other ingredients of this medicine (listed in section 6).
Severe nervous system side effects have been reported with the use of Atriance. Symptoms may be
mental (e.g. tiredness) or physical (e.g. convulsions, feelings of numbness or tingling, weakness and paralysis). Your doctor will check for these symptoms regularly during treatment (see also section 4, "Possible side effects").
Your doctor also needs to know the following before you are given this medicine:
with a live vaccine (for example polio, varicella, typhoid).
Your doctor should perform blood tests regularly during treatment to check for blood problems that
have been associated with the use of Atriance.
If you are an elderly person, you could be more sensitive to nervous system side effects (see the list above under “Warnings and precautions”). Your doctor will check for these symptoms regularly during treatment.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes any herbal products or medicines you have bought without a prescription Remember to tell your doctor if you start to take any other medicines while you are on Atriance.
Atriance is not recommended for pregnant women. It may harm a baby if conceived before, during or soon after treatment. Consideration to appropriate birth control is recommended to be discussed with
your doctor. Do not try and become pregnant/father a child until your doctor advises you it is safe to do so.
Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.
It is not known whether Atriance is passed on through breast milk. Breast-feeding must be discontinued while you are taking Atriance. Ask your doctor for advice before taking any medicine.
Atriance can make people feel drowsy or sleepy, both during and for some days after treatment. If you feel tired or weak, do not drive, and do not use any tools or machines.
This medicine contains 88.51 mg (3.85 mmol) sodium (main component of cooking/table salt) per vial
(50 ml). This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.
The dose of Atriance you are given will be based on:
The usual dose is 1,500 mg/m2 of body surface area per day.
The recommended dose is 650 mg/m2 of body surface area per day.
Your doctor will decide when to stop the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The majority of side effects reported with Atriance were seen in adults, children and adolescents. Some of the side effects were reported more often in adult patients. There is no known reason for this.
If you have any concerns, discuss them with your doctor.
These may affect more than 1 in 10 people treated with Atriance.
fever
serious deterioration of your general condition
local symptoms such as sore throat, sore mouth or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection)
These may affect more than 1 in 10 people treated with Atriance
Changes in the sense of feeling in hands or feet, muscle weakness appearing as difficulty getting up from a chair, or difficulty walking (peripheral neuropathy); reduced sensitivity to light
touch, or pain; abnormal sensations such as burning and, prickling, a sensation of something
crawling on the skin.
Feeling generally weak and tired (temporary anaemia). In some cases you may need a blood transfusion.
Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to even more severe bleeding (haemorrhage). Talk to your doctor for advice on how to
minimize the risk of bleeding.
Feeling drowsy and sleepy; headache; dizziness.
Shortness of breath, difficult or laboured breathing; cough.
Feeling of an upset stomach (nausea); being sick/throwing up (vomiting); diarrhoea; constipation
Muscle pain.
Swelling of parts of the body due to accumulation of abnormal amounts of fluid (oedema).
High body temperature (fever); tiredness; feeling weak/loss of strength.
These may affect up to 1 in 10 people treated with Atriance:
Violent, uncontrollable muscular contractions often accompanied by unconsciousness that can be due to an epileptic attack (seizures).
Clumsiness and lack of coordination affecting balance, walking, limb or eye movements, or
speech.
Unintentional rhythmic shaking of one or more limbs (tremors).
Muscle weakness (possibly associated with peripheral neuropathy – see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Lowered blood pressure.
Weight loss and loss of appetite (anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.
Problems with memory, feeling disoriented; blurred vision; altered or loss of sense of taste
(dysgeusia).
Build up of fluid around the lungs leading to chest pain and difficulty in breathing (pleural effusion); wheezing
Increased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.
Increases in blood levels of liver enzymes.
Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
The release of tumour cell contents (tumour lysis syndrome), which may put extra stress on your
body. Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort. If this does occur, it is most likely
to occur at the first dose. Your doctor will take appropriate precautions to minimise the risk of
this.
Low blood levels of some substances:
low calcium levels, which may cause muscle cramps, abdominal cramps or spasms
low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels.
low potassium levels may cause a feeling of weakness
low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.
These may affect up to 1 in 1,000 people treated with Atriance
Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
If you 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and vial. This medicine does not require any special storage conditions.
Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
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.
The active substance is nelarabine. Each ml of Atriance solution for infusion contains 5 mg of nelarabine. Each vial contains 250 mg of nelarabine.
The other ingredients are sodium chloride, water for injections, hydrochloric acid, sodium
hydroxide (see section 2 “Atriance contains sodium”).
Atriance solution for infusion is a clear, colourless solution. It is provided in clear glass vials with a
rubber stopper and sealed with an aluminium cap.
Each vial contains 50 ml.
Atriance is supplied in packs of 1 vial or 6 vials.
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
EBEWE Pharma Ges.m.b.H. Nfg.KG Mondseestrasse 11
4866 Unterach am Attersee Austria
Novartis Farmacéutica SA Ronda de Santa Maria 158
08210 Barberà del Vallès, Barcelona Spain
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Sandoz A/S
Tlf: +45 63 95 10 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH
Tel: +49 911 273 0
Novartis Pharma B.V.
Tel: +31 88 04 52 555
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Sandoz A/S
Tlf: +45 63 95 10 00
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Novartis Pharma GmbH
Tel: +43 1 86 6570
BEXAL FARMACÉUTICA, S.A.
Tel: +34 900 456 856
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
Sandoz
Tél: +33 800 45 57 99
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Sandoz S.R.L.
Tel: +40 021 4075160
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690
Sandoz A/S
Tel: +45 63 95 10 00
SIA Novartis Baltics
Tel: +371 67 887 070
Novartis Pharmaceuticals UK Ltd.
Tel: +44 1276 698370
This medicine 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 the medicine every year and
this leaflet will be updated as necessary.
There are also links to other websites about rare diseases and treatments.
The following information is intended for medical or healthcare professionals only:
This medicinal product does not require any special storage conditions. Atriance is stable for up to 8 hours at up to 30ºC once the vial is opened. Instructions for handling and disposal of Atriance
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Staff should be trained in how to handle and transfer the medicinal product.
Pregnant staff should be excluded from working with this medicinal product.
Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. Any liquid waste from the preparation of the nelarabine solution for infusion may be flushed with large amounts of water.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.