- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Farmacokinetische en farmacodynamische modellering van pediatrische gegevens (leeftijd van 2 tot <18 jaar met toegediende doses van 100 ug/kg), met inbegrip van aanvullende gegevens uit het fase II onderzoek en gecombineerd met eerdere farmacokinetische gegevens van volwassenen, ondersteunt dat vergelijkbare serumblootstellingen aan lipegfilgrastim werden bereikt bij
pediatrische patiënten als bij volwassen patiënten (SmPC)
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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
| Neutropenia resulting from cytotoxic chemotherapy |
|---|
|
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Renal impaiment in children > 3 months
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of lipegfilgrastim are not expected to be affected by renal impairment.(SmPC)
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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 safety profile in children is generally similar to that in adults. Some blood and lymphatic system disorders (anemia, lymphopenia, thrombocytopenia) and gastrointestinal system disorders (vomiting) were observed more frequently in children than in adults in clinical studies.
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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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| Colony stimulating factors | ||
|---|---|---|
| L03AA02 | ||
| Interferons | ||
|---|---|---|
| L03AB05 | ||
| L03AB11 | ||
| L03AB10 | ||
| Other immunostimulants | ||
|---|---|---|
| L03AX13 | ||
| L03AX15 | ||
| L03AX16 | ||
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Reference
- Teva B.V., SmPC Lonquex (EU/1/13/856) Rev 24, 18-10-2022, www.ema.europa.eu
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Changes
Changes
