Nelarabine (Specialist drug)

SOURCE: US FDA prescribing information only (NELARABINE, Alembic Pharmaceuticals Limited, label date 2024-08-07, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482d7978-12a5-467a-b10e-1789df5dd0f8). NO UK SPC was fetched in this bundle — the eMC provider is null — so this is US labelling and must be verified against a UK SPC before use. Verbatim: 'The recommended adult dose of nelarabine injection is 1,500 mg/m2 administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days.' DURATION: 'The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment.' DOSAGE MODIFICATION: DISCONTINUE nelarabine if the patient develops a neurologic adverse reaction of NCI CTCAE Grade 2 or greater. Dosage may be delayed for other toxicity, including haematologic toxicity. Severe neurologic reactions are the subject of the label's Boxed Warning; monitor for signs and symptoms of neurologic toxicity, and monitor complete blood counts including platelets regularly. HYPERURICAEMIA: take precautions against hyperuricaemia (e.g. hydration, urine alkalinisation, and prophylaxis with allopurinol). STABILITY: nelarabine injection is stable in PVC infusion bags and glass containers for up to 8 hours at up to 30 degrees C; inspect visually for particulate matter and discoloration before administration; discard the unused portion. PRODUCT STRENGTH: 250 mg/50 mL (5 mg/mL) single-dose vial. PAEDIATRIC — NOT structured in paedDose because the label's paediatric dose is body-surface-area based (mg/m2), not per kg: 'The recommended pediatric dose of nelarabine injection is 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Administer nelarabine injection undiluted.' Note the paediatric infusion time is 1 HOUR, versus 2 hours in adults. Safety and effectiveness for relapsed or refractory T-ALL and T-LBL have been established in paediatric patients age 1 year and older; haematologic toxicity in the paediatric population was higher than in adults, while the incidence of nervous system adverse reactions was lower (42% of paediatric patients across Phase I and II trials). Verify any under-18 use against a children's formulary. HEPATIC: nelarabine has not been studied in patients with hepatic dysfunction. ELDERLY: in an exploratory analysis, increasing age — especially 65 years and older — appeared to be associated with increased rates of neurologic adverse reactions; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. The pediatric, pregnancy, warnings and adverse-reactions sections were truncated at the source-fetch limit.