- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion |
|---|
|
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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 in children
The side effect profile in children is generally similar to the side effect profile in adults.
Adverse reactions that occurred more frequently in children compared to adults: ≥ 5% were neutropenia (19.8%), weight gain(18.7%), fractures (11%), lung infection (11%) and anemia (8.8%).
There were no differences in adverse events between children of different ages3 (infants, children up to 2 years of age, older children and adolescents).
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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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| Anthracyclines and related substances | ||
|---|---|---|
| L01DB02 | ||
| L01DB01 | ||
| L01DB06 | ||
| L01DB07 | ||
| Other cytotoxic antibiotics | ||
|---|---|---|
| L01DC01 | ||
| OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES | ||
|---|---|---|
| L01FX06 | ||
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Reference
- Roche Registration G, SmPC Rozlytrek (EU/1/20/1460/001) Rev 9; 3-7-2024, www.ema.europa.eu
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Changes
Changes
