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.

Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Posology
Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).

Adults and adolescents (aged 16 years and older)
The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days.
 

Children and adolescents (aged 21 years and younger)
The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m2 administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days.
 

In clinical studies, the 650 mg/m2 and 1,500 mg/m2 dose have both been used in patients in the age range 16 to 21 years. Efficacy and safety were similar for both regimens. The prescribing physician should consider which regimen is appropriate when treating patients in this age range. Limited clinical pharmacology data are available for patients below the age of 4 years.

Special populations
 

Elderly
Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients.
 

Renal impairment
Nelarabine has not been studied in individuals with renal impairment. Nelarabine and 9-β-Darabinofuranosylguanine (ara-G) are partially renally excreted. There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinine Clcr less than 50 ml/min. Patients with renal impairment must be closely monitored for toxicities when
treated with nelarabine.
 

Hepatic impairment
Nelarabine has not been studied in patients with hepatic impairment. These patients should be treated with caution.

For further information please refer to the attached files below.