WARNINGS
Do NOT receive IZERVAY if you:
Have an infection in or around your eye
Have active swelling in or around your eye that may include pain and redness
What should I avoid while receiving IZERVAY?
Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.
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)].
2. Neovascular AMD
In the GATHER1 and GATHER2 clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
3. Increase in Intraocular Pressure
Transient increases in intraocular pressure (IOP) have been observed after an intravitreal injection, including with IZERVAY [see Adverse Reactions (6.1)]. Perfusion of the optic nerve head should be monitored following the injection and managed as needed [see Dosage and Administration (2.4)].
USES
IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).
HOW TO USE
Please call your healthcare provider for more information.
What are the most common side effects of IZERVAY?
Blood in the white of the eye
Increase in eye pressure
Blurred vision
Wet age-related macular degeneration
These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.
ZERVAY can cause serious side effects:
Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).
Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.
There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.
IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.
N/A
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store IZERVAY in the refrigerator between 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F). Do not freeze. Do not shake.
Keep the vial in the original carton to protect from light.
Prior to use, the unopened glass vial of IZERVAY may be kept at room temperature, 20-degrees C to 25-degrees C (68-degrees F to 77-degrees F), for up to 24 hours. Ensure that the injection is given immediately after preparation of the dose.
NOTES
Medication Guide: revision date 09/2024
Prescribing Information: revision date 03/2025
Please call your healthcare provider for more information.
Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
Have high pressure in the eye or if you have glaucoma.
Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.
