INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

What is IZERVAY?

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).

What is the most important information I should know about IZERVAY?
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
IZERVAY 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 within minutes after the injection. Your healthcare provider will monitor this after each injection.
Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:
  • 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.
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.
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.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To request medical information or to report an adverse event or product complaint, please call 1-800-727-7003 or send an email to medinfo.americas@astellas.com.

Please see full Prescribing Information for more information.