Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following potentially serious adverse reactions are described elsewhere in the labeling: • Ocular and periocular infections [see Contraindications (4.1) ] • Active intraocular inflammation [see Contraindications (4.2) ] • Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] • Neovascular AMD [see Warnings and Precautions (5.2) ] • Increase in intraocular pressure [see Warnings and Precautions (5.3) ] The most common adverse reactions (incidence ≥ 5%) were conjunctival hemorrhage, increased IOP, blurred vision, neovascular age-related macular degeneration, punctate keratitis, and eye pain ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc.
at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of avacincaptad pegol was evaluated in 733 patients with AMD in two sham-controlled studies (GATHER1 and GATHER2).
Of these patients, 292 were treated with intravitreal IZERVAY 2 mg (0.1 mL of 20 mg/mL solution) [see Clinical Studies (14) ] .
Three hundred thirty-two (332) patients were assigned to sham.
Adverse reactions reported in ≥2% of patients who received treatment with IZERVAY for up to 12 months pooled across the GATHER1 and GATHER2 studies are listed below in Table 1 .
Table 1: Common Ocular Adverse Reactions (≥2%) and greater than Sham in Study Eye up to 12 months 1 Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently.
Adverse Drug Reactions IZERVAY N=292 Sham N=332 Conjunctival hemorrhage 13% 9% Increased IOP 9% 1% Blurred vision 1 8% 5% Choroidal neovascularization 7% 4% Eye pain 4% 3% Vitreous floaters 2% <1% Blepharitis 2% <1% Adverse reactions reported in ≥ 2% of patients who received treatment with IZERVAY for up to 24 months in the GATHER2 study are listed below in Table 2 .
5 WARNINGS AND PRECAUTIONS • Endophthalmitis and Retinal Detachments ( 5.1 ).
• Neovascular AMD ( 5.2 ) • Increase in Intraocular Pressure (IOP) ( 5.3 ).
5.1 Endophthalmitis and Retinal Detachments Intravitreal injections may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] .
Proper aseptic injection techniques must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] .
Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Patient Counseling Information (17) ] .
Like all medications, Izervay can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: