- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The pharmacokinetic properties of aflibercept were investigated in premature infants with ROP at a dose of 0.4 mg aflibercept (per eye).
After intravitreal injection, the concentrations of free and bound aflibercept were higher than in adult patients with wet AMD after administration of 2 mg (in one eye), but lower than after intravenous administration of the maximum tolerated dose of 1 mg/kg in adult patients. The mean concentrations of free aflibercept decreased to approximately 0.13 μg/ml at week 4 after administration. Plasma concentrations of free aflibercept decreased to levels below or near the lower limit of quantification within approximately 8 weeks. Mean concentrations of matched bound aflibercept increased up to 1.34 μg/ml at week 4 and decreased thereafter. [SmPC Eylea]
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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
| Retinopathy of prematurity (ROP) |
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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
Adverse reactions reported in more than one patient treated with 0.4 mg aflibercept were retinal detachment, haemorrhage into the retina, conjunctival haemorrhage, haemorrhage at the injection site, increased intraocular pressure and eyelid oedema. The long-term safety profile in premature infants has not been determined.
The adverse reactions observed for the adult indications also apply to preterm infants with ROP, although not all were observed in the Phase III trial. [SmPC Eylea]
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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 premature retinopathy, instruct parents to have immediate contact when the following symptoms occur: redness/irritation of the eye, discharge from the eye, eyelid swelling or photophobia.
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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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| Antineovascularisation agents | ||
|---|---|---|
| S01LA04 | ||
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Reference
- Bayer AG, SmPC Eylea (EU /1/12/797/001) Rev28. 10-2-2023, www.ema.europa.eu
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Changes
Changes
