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ATRIANCE

 
Package:
VIALS: 6 x 50 ml x 250 mg/vial.
Dosage:
Must only be administered under the supervision of a physician experienced in the use of cytotoxic agents. Recommened to receive I.V. hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumour lysis syndrome. Adults and adolescents (aged 16 years and older): 1,500 mg/m²administered I.V. over two hours on days 1, 3 and 5 and repeated every 21 day. Children and adolescents (aged 21 years and younger): 650 mg/m² administered I.V. over one hour daily for 5 consecutive days, repeated every 21 days.
Prescribing Restrictions:     


Indications:
For the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions:
Severe neurological events such as: altered mental states, central nervous system effects, severe somnolence, convulsions, peripheral neuropathy. Neurotoxicity is the dose-limiting toxicity. Immunisations with live organism vaccines are not recommended. Leukopenia, thrombocytopenia, anemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy. Complete blood counts including platelets must be monitored regularly. There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre Syndrome. close monitoring for neurological events is strongly recommended, and nelarabine must be discontinued at the first sign of neurological events of NCI CTCAE Grade 2 or greater. Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events. Patients are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk of tumour lysis syndrome. For patients at risk of hyperuricemia, the use of allopurinol should be considered. This medicinal product contains 1.725 mg/ml (75 mmol) of sodium. To be taken into consideration by patients on a controlled sodium diet. 
Pregnancy and lactation: Should not be used during pregnancy unless clearly necessary. Breastfeeding should be discontinued. See prescribing information for full details.
Side Effects:
The most frequently occurring adverse events were fatigue, GI disorders, hematological disorders, respiratory disorders, nervous system disorders, and pyrexia. Neurotoxicity is the dose limiting toxicity associated with nelarabine therapy. Infection, including (but not limited to): sepsis, bacteremia, pneumonia, fungal infection; tumor lysis syndrome; febrile neutropenia, neutropenia, leukopenia, thrombocytopenia, anemia. See prescribing information for full details.
Drug Interactions:
Adenosine deaminase inhibitors, such as pentostatin