Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Nelarabine

Generic name
Nelarabine
Brand name
ATC Code
L01BB07

Pharmacokinetics in children

Paediatric patients:

  Dose Nelarabin ara - G 
Cmax - Plasma 650 mg/m2 45.0 µM 60.1 µM
Vd 104 - 2,900 mg/m2 89.4 L/m2 32.1 L/m2
T1/2 650 mg/m2 30 min 3 h
Cl 104 - 2,900 mg/m2 125 L/h/m2 10.8 L/h/m2

[SmPC Atriance]

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

T-ALL, T-LBL
  • Intravenous
    • < 16 years
      • 650 mg/m²/day in 1 dose run in over 1 hour for 5 consecutive days in a cycle of 21 days..
    • 16 years up to 21 years
      • 650 - 1.500 mg/m²/day in 1 dose
      • 650 mg/m²: run in over 1 hour for 5 consecutive days in a cycle of 21 days.
        1500 mg/m²: run in over 2 hours on days 1, 3 and 5 in a cycle of 21 days

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

One fatal case of status epilepticus was reported in a child.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Reference

  1. Sandoz Pharmaceuticals d.d, SmPC Atriance (EU/1/07/403/001) Rev 28, 13-05-2024, www.ema.europa.eu

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Changes

Changes