ATRIANCE

Generic Name/API: nelarabine

Manufacturer: Novartis

Dosage Forms & Strength & Pack Size:

• 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”).
Each vial contains 50 ml.
Atriance is supplied in packs of 1 vial or 6 vials.

Storage:
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.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

Indications
Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents, used in chemotherapy to kill some types of cancer cells.

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. 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

Warnings and precautions
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”).
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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).
• if you (or your child, if he/she is being treated) have any blood problems (for example
anaemia).
Blood tests during treatment
Your doctor should perform blood tests regularly during treatment to check for blood problems that
have been associated with the use of Atriance.
Elderly
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 if any of these apply to you.
Other medicines and Atriance
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.
Pregnancy, breast-feeding and fertility
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.
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.
Atriance contains sodium
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.

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