Tisagenlecleucel

Generic name
Tisagenlecleucel
Brand name
ATC Code
L01XL04
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Tisagenlecleucel

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

 

  Responding patients (n=105) Non-responding patients (n=12)
Cmax (geometric mean and (CV%)) 35.300 (154,0) copies/microg
(n=103)		 21.900 (80,7) copies/microg (n=10)
Tmax (median and [min;max]) 9,83 [5,70;27,8] days (n=103) 20,1 [12,6;62,7] days
(n=10)
t1/2 (geometric mean and (CV%)) 25,2 (307,8) days
(n=71)		 3,80 (182,4) days
(n=4)

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Recurrent/refractory B-cell acute lymphoblastic leukaemia (ALL)
  • Intravenous
    • ≥ 1 month and < 50 kg

      • 0.2 - 5 x106 cells/kg

    • ≥ 1 month and ≥ 50 kg

      • 0.1 - 2.5 x108 cells
Oncological conditions
  • Intravenous
    • 0 years up to 18 years

      • Dose and dose frequency of cytostatics depend on the condition and are highly subject to new insights. Cytostatics are often used in combination in oncology/hematology. For these reasons, reference is made to the detailed treatment protocols.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Side effects

No information is present at this moment.

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 in children

In almost all cases, development of cytokine release syndrome occurred between 1 to 10 days (median onset 3 days) after Tisagenlecleucel infusion in paediatric and young adult B-cell ALL patients. [SmPC Kymriah]

Interactions

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

OTHER ANTINEOPLASTIC AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Methylhydrazines
L01XB01
MONOKLONALE ANTILICHAMEN
L01XC11
L01XC18
L01XC18
Other antineoplastic agents
L01XX01
L01XX02
L01XX05
L01XX23
L01XX24
L01XX14
Proteasome inhibitors
L01XG01

Reference

  1. Novartis Europharm Limited, SmPC Kymriah (EU/1/18/1297/001) 06-07-2021, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose