- 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) |
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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
| Recurrent/refractory B-cell acute lymphoblastic leukaemia (ALL) |
|---|
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| Oncological conditions |
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
No information is present at this moment.
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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 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]
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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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| Methylhydrazines | ||
|---|---|---|
| L01XB01 | ||
| MONOKLONALE ANTILICHAMEN | ||
|---|---|---|
| L01XC11 | ||
| L01XC18 | ||
| L01XC18 | ||
| Other antineoplastic agents | ||
|---|---|---|
| L01XX01 | ||
| L01XX02 | ||
| L01XX05 | ||
| L01XX23 | ||
| L01XX24 | ||
| L01XX14 | ||
| Proteasome inhibitors | ||
|---|---|---|
| L01XG01 | ||
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Reference
- Novartis Europharm Limited, SmPC Kymriah (EU/1/18/1297/001) 06-07-2021, www.ema.europa.eu
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Changes
Changes
