Atriance 5 mg/ml solution for infusion

Atriance belongs to a group of medicines used to treat some types of cancer.

Atriance is used to treat patients with:

• a type of leukaemia, called T-cell acute lymphoblastic leukaemia. Leukaemia causes an abnormal increase in the number of white blood cells in the body, and sometimes also the blood. The type of leukaemia relates to the type of white blood cell mainly involved. In this case, its cells 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.

You (or your child, if he/she is being treated) must not receive Atriance

• if you (or your child, if he/she is being treated) are allergic (hypersensitive) to nelarabine or any of the other ingredients of Atriance.

Take special care with Atriance
Severe neurological side effects have been reported with the use of Atriance. Symptoms have included altered mental states (e.g. tiredness), effects on your nervous system (e.g. convulsions, feelings of numbness or tingling, weakness and paralysis). Your doctor will check for these symptoms regularly (see also ?Possible side effects").

Your doctor also needs to know the following before you are given this medicine:

• if you (or your child, if he/she is being treated) have any kidney or liver problems. Your dose of Atriance may need to be adjusted
• if you (or your child, if he/she is being treated) have recently been, or plan to be vaccinated with a live vaccine (for example Polio, Varicella, Typhoid)

Tell your doctor if any of these apply to you.

Using other medicinesTell your doctor if you are taking any other medicines, or have recently taken any. 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. Pregnancy and breast-feeding
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.

See "Take special Care with Atriance".

Driving and using machines
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.

Important information about some of the ingredients of Atriance
This medicine contains at least 23 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

The dose of Atriance you are given will be based on:

• your/your child's (if he/she is being treated) body surface area (which will be calculated by your doctor based on your height and weight).
• the results of blood tests carried out before treatment

Adults and adolescents (aged 16 years and older)

The usual dose is 1,500 mgm2 of body surface area per day.

A doctor or nurse will give you a suitable dose of Atriance as an infusion (a drip). It is usually

dripped into your arm over a period of about 2 hours.

You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment. This pattern of treatment will normally be repeated every three weeks. This treatment may vary, depending on the results of your regular blood tests.

Children and adolescents (aged 21 years and younger)

The usual dose is 650 mgm2 of body surface area per day.

A doctor or nurse will give you/your child (if he/she is being treated) a suitable dose of Atriance as

an infusion (a drip). It is usually dripped into your arm over a period of about 1 hour.

You/your child (if he/she is being treated) will have an infusion (a drip) once a day for 5 days. This pattern of treatment will normally be repeated every three weeks. This treatment may vary, depending on the results of regular blood tests.

Stopping treatment with Atriance

Your doctor will decide when to stop the treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Atriance 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.

Very Common side effects

These may affect more than 1 in 10 people treated with Atriance.

• Signs of infection. Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia). This can even be life threatening. Signs of an infection include:
• fever
• serious deterioration of your general condition
• local symptoms such as sore throat, sore mouth or urinary problems (for example, a burningsensation when urinating, which may be a urinary infection)

Tell your doctor immediately if you get any of these. A blood test will be taken to check possible reduction of white blood cells.

Other very common side effects

• 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.

Tell a doctor if any of these becomes troublesome.

Common side effects

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.

Tell a doctor if any of these becomes troublesome.

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.

Keep out of the reach and sight of children.

Do not use Atriance after the expiry date which is stated on carton and vial.

This medicinal product 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Atriance contains

• The active substance of Atriance 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

What Atriance looks like and contents of the pack

Atriance solution for infusion is a clear, colourless solution. It is provided in clear glass vials with a non-latex containing rubber stopper and sealed with an aluminium cap.

Each vial contains 50 ml.

Atriance is supplied in packs of 6 vials.

Marketing Authorisation Holder
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.

Manufacturer
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations): Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 infoglaxosmithkline.dk Nederland GlaxoSmithKline BV Tel 31 030 6938100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel. 49 089 36044 8701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OU Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z.o.o. Tel. 48 022 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 01 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Limited Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Tel 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 045 9218 111 SuomiFinland GlaxoSmithKline Oy PuhTel 358 010 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 89 95 01 Sverige GlaxoSmithKline AB Tel 46 031 67 09 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0800 221441 customercontactukgsk.com Lietuva GlaxoSmithKline Lietuva UAB Tel 370 5 264 90 00 info.ltgsk.com

This leaflet was last approved in {MM/YYYY}

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.

The following information is intended for medical or healthcare professionals only:

INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE

Storage of Atriance solution for infusion

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. Liquid waste may be flushed with large amounts of water.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.