5 mg / ml Infusion solution 
nelarabine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Atriance is and what it is used for 
2. What you need to know before you receive Atriance 
3. How Atriance is given 
4. Possible side effects 
5. How to store Atriance 6. Contents of the pack 
and other information

1. What Atriance is and what it is used for

Atriance contains nelarabine belonging to a group of products known as a ntineoplastiska agents, which are used in chemotherapy to kill certain types of cancer cells.

Atriance is used to treat patients with:

  • a type of leukemia , so-called acute lymphocytic leukemia of the T-cell type. Leukemia causes an abnormal increase in the number of white blood cells . The abnormally high number of white blood cells can occur in the blood and other parts of the body. The type of leukemia is related to the type of white blood cellsthat are mainly affected. In this case, the cells are called lymphoblasts .
  • a form of lymphoma , so-called T-cell lymphoblast lymphoma. This lymphoma iscaused by lymphoblasts , a type of white blood cell .

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

2. What you need to know before you get Atriance

You (or your child, if he / she is treated) should not be treated with Atriance

  • 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 6.1).

Warnings and cautions

Severe side effects on the nervous system have been reported during treatment with Atriance. Symptoms can be mental (eg fatigue) or physical (leg cramps, numbness or tingling, weakness and paralysis). Your doctor will regularly examine you during treatment for these symptoms (see also section 4, “Possible side effects”).

Before taking this medicine, your doctor must tell you:

  • if you (or your child, if he / she is being treated) have 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 vaccinated or are planning to tvaccinated with live vaccine (for example, polio, chickenpox or typhoid).
  • if you (or your child, if he / she is being treated) have any problems with the blood (eg anemia ).

Blood tests during treatment

Your doctor will take regular blood tests during treatment to detect any blood problems that have been linked to the use of Atriance.

Older

If you are an elderly person, you may be more sensitive to side effects on the nervous system (see “Warnings and Precautions”). Your doctor will regularly examine you during treatment for these symptoms.

Tell your doctor if any of these apply to you.

Other drugs and Atriance

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to all natural remedies or medicines that you bought without a prescription.

Remember to tell your doctor if you start taking any other medicines while you are receiving Atriance.

Pregnancy, breastfeeding and fertility

Atriance is not recommended for pregnant women. It can harm a baby born before, during or shortly after treatment. You should discuss with your doctor which contraceptive method is right for you. Do not try to get pregnant, or if you are a man, give birth to a child until your doctor says it is safe to do so.

Male patients who wish to have a child should ask their doctor for advice on family planning or treatment. If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.

It is not known if Atriance passes into breast milk. Breast-feeding must be stopped while you are being treated with Atriance. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Atriance can make people feel drowsy or sleepy both during and a few days after treatment. If you feel tired or weak, do not drive or use any tools or machines.

Atriance contains sodium

This medicine contains 88.51 mg (3.85 mmol) of sodium (the main ingredient in common salt / table salt) per vial (50 ml). This corresponds to 4.4% of the highest recommended daily intake of sodium for adults.

3. How Atriance is given

The Atriance- dose you receive is based on:

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

Adults and adolescents (16 years and older) 

The usual dose a is 1500 mg / m 2 of body surface per day.

A doctor or nurse will give you a dose of Atriance as an infusion (drip). You usually get the drop in your arm for about 2 hours.

You will receive an infusion (drip) once daily, days 1, 3 and 5 of the treatment . This treatment schedule is normally repeated every three weeks. The treatment may change depending on the results of the blood tests taken regularly. The doctor decides how many treatment periods are needed.

Children and adolescents (21 years and younger) 

The recommended dose is 650 mg / m 2 body surface area per day.

A doctor or nurse will give you / your child (if he / she is being treated) the right dose of Atriance as an infusion (drip). You usually get the drop in your arm for about 1 hour.

You / your child (if he / she is treated) will receive an infusion (drip) once daily for 5 days . This treatment schedule is normally repeated every three weeks. The treatment may change depending on the results of the blood tests taken regularly. The doctor decides how many treatment periods are needed.

Discontinue treatment with Atriance

The doctor decides when to stop the treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the side effects reported with Atriance treatment were seen in adults, children and adolescents. Some side effects have been reported more frequently in adult patients. There is no known cause for this.

If you have any further questions, ask your doctor.

Most serious side effect s

These side effects may affect more than 1 in 10 people treated with Adriance.

  • Signs of infection . Atriance may reduce the number of white blood cells and reduce the resistance to infection (including pneumonia ). This can even be life-threatening. Signs of an infection include:
    • fever
    • severe deterioration of your general condition
    • local symptoms, such as sore throat, mouth ulcers or urinary tract problems (a burning sensation such as urinating may be a urinary tract infection).

Tell your doctor immediately if you get any of these side effects . A blood sample is taken to check for a possible reduction in the white blood cells .

Other very common side effects are

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

  • Altered sensation in hands or feet, muscle weakness in the form of difficulty getting up from a chair or difficulty walking ( peripheral neuropathy ), decreased sensitivity to light touch or pain, abnormal sensations in the skin, such as a burning or stinging sensation or feeling that something is crawling on the skin.
  • A general feeling of weakness and tiredness (temporary anemia ) . In some cases, you may need a blood transfusion .
  • Unusual bruising or bleeding caused by a decrease in the number of coagulating cells in the blood. It can lead to severe bleeding from relatively small injuries, such as a small cut. In rare cases, it can lead to even more severe bleeding ( hemorrhage ) . Talk to your doctor for advice on how to minimize the risk of bleeding.
  • A feeling of drowsiness and drowsiness, headache, dizziness.
  • Shortness of breath, strained or heavy breathing, cough.
  • Anxious stomach (nausea) vomiting, diarrhea, constipation.
  • Muscle pain.
  • Swelling in various parts of the body, caused by an abnormal accumulation of fluid ( edema ).
  • High body temperature (fever), fatigue, feeling weak, lack of energy.

Tell your doctor if any of these side effects gets serious.

Common side effects are

These can occur in up to 1 in 10 people treated with Atriance:

  • Severe, uncontrollable muscle contractions, often accompanied by unconsciousness that may be due to an epileptic seizure (seizures).
  • Clumsiness and lack of coordination affect balance, gait, arm and leg movements, eye movements, or speech.
  • Unintentional rhythmic shaking of one or more extremities s ( tremor ).
  • Muscle weakness (possibly linked to peripheral neuropathy – see above), joint pain, back pain, pain in hands and feet, including ant crawling and numbness.
  • Lowered blood pressure.
  • Weight loss and decreased appetite ( anorexia ), stomach pain, mouth ulcers, cold sores, or inflammation.
  • Problems with memory, disorientation, blurred vision, taste changes, or loss of taste ( dysgeusia ).
  • Accumulation of fluid around the lungs, which causes pain in the chest and difficulty breathing (pleural effusion), wheezing or wheezing.
  • Increased levels of bilirubin in the blood, which can cause yellowing of the skin and make you feel extremely tired.
  • The increased amount of liver enzymes in the blood.
  • Elevated creatinine levels in the blood (a sign of kidney problems, which may make you need to urinate less often).
  • Release of the tumor cell contents (tumor lysis syndrome), which can increase the stress on the body. Symptoms that initially include nausea and vomiting, shortness of breath, irregular heartbeat, cloudy urine, extreme fatigue, and/or joint problems. If this happens, it is likely to occur at the first dose. Your doctor will take appropriate measures to minimize this risk.
  • Low blood levels of certain substances:
    • low calcium levels, which can cause muscle cramps, stomach cramps, or stomach spasms
    • low magnesium levels, which can cause muscle weakness, confusion, jerky movements, high blood pressure, irregular heartbeat, and decreased reflexes with severely low magnesium levels in the blood.
    • Low potassium levels can make you feel weak.
    • low glucose levels, which may cause nausea, sweating, weakness, lethargy, confusion, or hallucinations.

Tell your doctor if any of these side effects gets serious.

Rare side effects are

These can occur in up to 1 in 1,000 people treated with Atriance:

  • Severe disease that destroys skeletal muscle, characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine ( rhabdomyolysis ), increase in creatine phosphokinase in the blood.

Tell your doctor if any of these become troublesome.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Atriance

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 instructions.

Atriance is stable for up to 8 hours at up to 30 ° C after opening the vial

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.

6. Contents of the packaging and other information

Content declaration

  • 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, and hydrochloric acid/sodium hydroxide (see section 2 “Atriance contains sodium”).

What the medicine looks like and the contents of the pack

Atriance infusion solution is a clear, colorless solution. It is supplied in clear glass vials with a rubber stopper with an aluminum seal.

Each vial contains 50 ml.

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

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

EBEWE Pharma Ges.mbH Nfg.KG

Mondseestrasse 11

4866 Unterach am Attersee

Austria

Novartis Pharmacéutica SA

Ronda de Santa Maria 158

08210 Barberà del Vallès, Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkSandoz A / STel: +45 63 95 10 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 555
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwaySandoz A / STel: +45 63 95 10 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainBEXAL PHARMACEUTICALS, SATel: +34 900 456 856 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceSandozTel: +33 800 45 57 99 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaSandoz SRLTel: +40 021 4075160
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

Leave a Reply