Prospect: information for the patient

Atriance 5mg/ml infusion solution

nelarabina

Thismedication is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect thoroughly before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section4.

1.What Atriance is and for what it is used

2.What you need to know before they start administering Atriance to you

3.How Atriance is administered

4.Possible adverse effects

5.Storage of Atriance

6.Contents of the package and additional information

Atriance contains nelarabina, which belongs to a group of medications known asantineoplastic agentsused in chemotherapy to eliminate some types of cancer cells.

Atriance is used to treat patients with:

• a type of leukemia called T-cell acute lymphoblastic leukemia. Leukemia causes an abnormal increase in the number of leukocytes. This abnormal elevation in the number of leukocytes may appear in the blood or in other parts of the body. The type of leukemia refers to the type of leukocytes mainly affected. In this case, lymphoblast cells.
• a type of lymphoma called T-cell lymphoblastic lymphoma. This lymphoma is caused by an accumulation of lymphoblasts, a type of leukocyte.

If you have questions about your disease, consult with your doctor.

You or your child (if they are being treated) should not receive Atriance

• If you (or your child, if they are being treated) are allergic to nelarabina or any of the other components of this medication (listed in section6).

Warnings and Precautions

Severe neurological side effects have been reported with the use of Atriance. Symptoms include altered mental state (e.g., fatigue), neurological system alterations (e.g., seizures, numbness or tingling, weakness, and paralysis).Your doctor will regularly check for these symptoms (see also “Possible side effects”).

Your doctor needs to know the following information before administering this medication:

• If you (or your child, if they are being treated) have any kidney or liver problems. You may require a dose adjustment of Atriance
• If you (or your child, if they are being treated) have recently been vaccinated or will be vaccinatedwith a live vaccine (e.g., polio, varicella, typhoid).
• If you (or your child, if they are being treated) have any blood problems(e.g., anemia).

Blood tests during treatment

Your doctor should perform regular blood tests during treatment to detect blood problems associated with the use of Atriance.

Older adults

If you are an older adult, you may be more sensitive to the side effects that affect the nervous system (see the list above in “Warnings and Precautions”). Your doctor will regularly check for these symptoms during treatment.

Inform your doctor if you are in any of these situations.

Other medications and Atriance

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.This includes any herbal products or over-the-counter medications.

Remember to inform your doctor if you start using any medication while being treated with Atriance.

Pregnancy, breastfeeding, and fertility

Atriance is not recommended for pregnant women. It may harm the baby if conceived before, during, or shortly after treatment. Your doctor recommends that you use an appropriate birth control method. Do not attempt to become pregnant or become pregnant with your partner until your doctor tells you it is safe to do so.

Men who wish to father a child should consult their doctor about family planning or treatment. Inform your doctor immediately if you become pregnant during treatment with Atriance.

The safety of Atriance during breastfeeding is unknown. You should stop breastfeeding while being treated with Atriance. Consult your doctor before taking any medication.

Driving and operating machinery

Atriance may cause drowsiness during treatment and for several days after treatment. If you feel tired or weak, do not drive and do not operate tools or machinery.

Atriance contains sodium

This medication contains 88.51mg (3.85-mmoles) of sodium (main component of table salt/for cooking) in each vial(50ml). This is equivalent to 4.4% of the maximum daily sodium intake recommended for an adult.

The dose of Atriance you will receive will be based on:

• Your body surface area/your child's body surface area (if your child is being treated)(which your doctor will calculate based on your height and weight).
• Results of blood testsperformed before treatment.

Adults and Adolescents (16 years and older)

The usual doseis 1,500mg/m2of body surface area per day.

A doctor or nursewill administer the appropriate dose of Atriance through an infusion (a drip). Normally it is placed in the arm and the administration usually lasts about 2hours.

You will receive an infusion (a drip) once a day on days1, 3, and 5 of treatment. This treatment schedule will be repeated generally every three weeks. This treatment may vary, depending on the results obtained in your periodic blood tests. Your doctor will decide how many treatment cycles you may need.

Children and Adolescents (21 years or younger)

The usual doseis 650mg/m2of body surface area per day.

A doctor or nursewill administer to you/your child (if your child is being treated) an appropriate dose of Atriance through aninfusion(a drip). Normally it is placed in the arm and the administration usually lasts around 1hour.

You/your child (if your child is being treated) will receive Atriance through an infusion (a drip) once a day for 5days. This treatment schedule will be repeated generally every three weeks. This treatment may vary, depending on the results obtained in periodic blood tests. Your doctor will decide how many treatment cycles you may need.

Discontinuation of Atriance Treatment

Your doctor will decide when to discontinue treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of side effects reported with Atriance were observed in adults, children, and adolescents. Some side effects were reported more frequently in adults. The reason is unknown.

If you have any doubts, consult your doctor.

Very common side effects

May affectmore than 1 in 10peopletreated with Atriance.

• Signs of infection. Atriance may reduce the number of white blood cells and decrease their resistance to infection (including pneumonia). This may pose a risk to life. Among the signs of an infection are:

• Fever
• Severe deterioration of your general state
• Local symptoms such as sore throat or mouth or urinary problems (for example, burning sensation while urinating, which may be due to a urinary tract infection)

Inform your doctor immediatelyif you notice any of these signs. A blood test should be performed to check for a possible reduction in the number of white blood cells.

Other very common side effects

• Changes in sensation in hands or feet, muscle weakness that appears 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 tingling in the skin.
• General feeling of weakness and fatigue (temporary anemia). In some cases, a blood transfusion may be necessary.
• Unexplained bruises or bleeding, caused by a decrease in the number of cells that participate in blood clotting. This may lead to severe bleeding from relatively small injuries such as small cuts. Rarely, this may lead to more severe bleeding (hemorrhage). Talk to your doctor to advise on how to minimize the risk of bleeding.
• Drowsiness; headache; dizziness.
• Labored or difficult breathing; cough.
• Unpleasant feeling in the stomach (nausea); vomiting; diarrhea, constipation
• Muscle pain.
• Swelling in some areas of the body, caused by abnormal retention of fluids (edema).
• Elevated body temperature (fever); fatigue; feeling of weakness/loss of strength.

Inform your doctorif any of these side effects become bothersome.

Common side effects

May affectup to 1 in 10peopletreated with Atriance:

• Violent, uncontrollable muscle contractions, often accompanied by loss of consciousness that may be due to a seizure (crisis).
• Clumsiness and lack of coordination, affecting balance, walking, limb or eye movements, or speech.
• Accidental, rhythmic shaking of one or more limbs (tremors).
• Muscle weakness (possibly associated withperipheral neuropathy– see above), joint pain, back pain, hand and foot pain, including tingling and numbness.
• Decreased blood pressure.
• Weight loss and loss of appetite (anorexia), stomach pain, mouth pain, ulcers or inflammation of the mouth.
• Memory problems, disorientation, blurred vision, loss or alteration of taste (disgeusia).
• Appearance of fluid around the lungs, causing chest pain and difficulty breathing (pleural effusion), wheezing.
• Increased levels of bilirubin in the blood, which may cause yellow skin and make you feel drowsy.
• Increased levels of liver enzymes in the blood.
• Increased levels of creatinine in the blood (a sign of kidney problems, which may produce decreased urination frequency).
• Release of tumor cell content (tumor lysis syndrome), which may cause stress to your body. The initial symptoms are nausea, vomiting, difficult breathing, irregular heartbeat, dark urine, numbness, and/or joint discomfort. If this happens to you, it is more likely to occur with the first dose. Your doctor will take the necessary precautions to minimize the risk of this occurring.
• Decreased levels of certain substances in the blood:

• Decreased levels of calcium, which may cause muscle cramps, abdominal cramps, or spasms.
• Decreased levels of magnesium, which may cause muscle weakness, confusion, tremors, high blood pressure, irregular heartbeat, and decreased reflexes with severely decreased magnesium levels in the blood.
• Decreased levels of potassium, which may cause a feeling of weakness.
• Decreased levels of glucose, which may cause nausea, sweating, weakness, fainting, confusion, or hallucinations.

Inform your doctorif any of these side effects become bothersome.

Rare side effects

These may affectup to 1 in 1,000peopletreated with Atriance

• Severe disease (Rhabdomiolisis) that destroys skeletal muscle, characterized by the presence of myoglobin (product of muscle cell rupture) in the urine, and increased levels of creatine phosphokinase in the blood.

Inform your doctorif any of these side effects become bothersome.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through the national notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the vial.

This medication does not require special storage conditions.

Once the vial is opened, Atriance is stable for 8 hours at a temperature of up to 30°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Atriance

• The active ingredient is nelarabina. Each milliliter of Atriance solution for infusion contains 5 mg of nelarabina. Each vial contains 250 mg of nelarabina.
• The other components are sodium chloride, water for injection, hydrochloric acid/sodium hydroxide.

Appearance of the product and contents of the container

Atriance solution for infusion is a transparent, colorless solution. It is supplied in transparent glass vials with rubber stoppers sealed with an aluminum ring.

Each vial contains 50 ml.

Atriance is supplied in packs of 1 vial or 6 vials.

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Ljubljana

Slovenia

Responsible Person

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

EBEWE Pharma Ges.m.b.H. Nfg.KG

Mondseestrasse 11

4866 Unterach am Attersee

Austria

FAREVA Unterach GmbH

Mondseestraße 11

Unterach am Attersee, 4866,

Austria

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

This medicine has been authorized in «exceptional circumstances». This authorization modality means that due to the rarity of the disease, it has not been possible to obtain complete information about this medicine.

The European Medicines Agency will review the new information available for this medicine annually and this leaflet will be updated as necessary.

More detailed information about this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/. It also provides links to other websites about rare diseases and orphan medicines.

This information is intended only for healthcare professionals:

INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE

Storage of Atriance solution for infusion

This medicine does not require special storage conditions.

Once opened, Atriance is stable for 8 hours at a temperature of up to 30°C.

Instructions for handling and disposal of Atriance

Follow the usual procedures for handling and disposing of anticancer medicines:

• Staff should be trained in how to handle and transfer the medicine.
• Healthcare staff should not handle this medicine during pregnancy.
• During handling/transfer of the medicine, healthcare staff should wear protective clothing, including a mask, protective glasses, and gloves.
• All items used for administration or cleaning, including gloves, should be placed in high-risk waste bags for incineration at high temperature. Any liquid waste from the preparation of nelarabina solution for infusion can be disposed of with abundant water.
• Accidental contact with the skin or eyes should be treated immediately with abundant water.