Patizra Special Precautions

Intravitreal injection-related reactions: Intravitreal injections, including those with Patizra, 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 Patizra. 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 Patizra (see Adverse Reactions). Sustained IOP increases have also been reported. Both intraocular pressure and the 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 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 Patizra treatment is appropriate whether the benefit outweighs the potential risk.
Immunogenicity: As with all therapeutic proteins, there is a potential for immunogenicity with Patizra.
Bilateral treatment: Available data do not suggest an increased risk of systemic adverse events with bilateral treatment.
An immune reaction to Patizra was seen in 0-3% of patients in all treatment groups prior to treatment. Following monthly administration, low antibody titres were detected in 1-6% of patients after 12-24 months. These immunogenicity data reflect the percentage of patients in whom electrochemiluminescence test results were positive. The data were highly dependent on the sensitivity and specificity of the test. The clinical significance of immune reactions to Patizra is unclear at this time. Iritis and vitritis were reported in some patients with the highest immunoreactivity titres.
Although there was a low rate (<4%) of arterial thromboembolic events observed in the Patizra clinical trials, there is a theoretical risk of arterial thromboembolic events following intravitreal use of inhibitors of VEGF (see Adverse Reactions).
Patient populations with limited data: Patizra has not been studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole.
Effects on ability to drive and use machines: The Patizra 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.