Italian Medicines Agency Agenzia Italiana del Farmaco

EYLEA 40 mg/mL: Higher risk of intraocular pressure increase with the pre-filled syringe - EYLEA 40 mg/mL: Higher risk of intraocular pressure increase with the pre-filled syringe

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EYLEA 40 mg/mL: Higher risk of intraocular pressure increase with the pre-filled syringe

EYLEA 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe.

Summary

  • Cases of increased intraocular pressure have been reported more frequently (estimated up approximately seven-fold) when using the Eylea pre-filled syringe, compared with administration with Luer-lock syringe of Eylea solution for injection in a vial.
  • Incorrect handling in the preparation and injection is suspected as the most probable root cause of the observed cases of increased intraocular pressure with the Eylea pre-filled syringe. Injections should be performed by health care professionals familiar with the handling of this presentation.
  • Correct handling of the pre-filled syringe and training are key to mitigate this risk: 
    • use a 30G x 13mm injection needle; 
    • always check that the excess volume/air bubbles in the pre-filled syringe is eliminated before use: the base of the plunger dome (not the tip of the dome) must be aligned with the black dosing line on the syringe (see below);
    • carefully depress the plunger rod;
    • administer the exact recommended dose and do not inject any residual volume, as increased injection volume can lead to clinically relevant intraocular pressure elevation.
  • Evaluate the patient’s vision and monitor intraocular pressure immediately after the intravitreal injection.


Published on: 15 April 2021

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