Lucentis Special Precautions

Intravitreal injection-related reactions: Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see Adverse Reactions). Proper aseptic injection techniques must always be used when administering Lucentis. In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs. Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the previously mentioned events without delay.
In adults, transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis (see Adverse Reactions). Sustained IOP increases have also been reported. Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately.
Arterial thromboembolic events: There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF (vascular endothelial growth factor) inhibitors. In the wet AMD Phase III studies, the overall frequency of arterial thromboembolic events was similar between ranibizumab and control. A numerically higher stroke rate was observed in patients treated with ranibizumab 0.5 mg compared to ranibizumab 0.3 mg or control, however, the differences were not statistically significant. The difference in stroke rates may be greater in patients with known risk factors for stroke, including history of prior stroke or transient ischemic attack. Therefore, these patients should be carefully evaluated by their physicians as to whether Lucentis treatment is appropriate and whether the benefit outweighs the potential risk.
Immunogenicity: As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis.
Bilateral treatment: Available data do not suggest an increased risk of systemic adverse events with bilateral treatment.
Patient populations with limited data: Lucentis has not been studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole.
Driving and using machines: The Lucentis treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see Adverse Reactions). Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.