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
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