Pegcetacoplan (Intraocular)

Pegcetacoplan injection is used to treat geographic atrophy (GA) caused by age-related macular degeneration (AMD). AMD is a condition of the retina in the eye that can lead to blurred vision or blindness. Pegcetacoplan works by altering the blood flow to the eye.

This medicine will only be given by your doctor.

Your eye doctor will want to monitor your progress closely and have regular visits, especially during the first few days after you receive this medicine, to ensure it is working properly and to check for any unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for at least 40 days after the last dose. If you think you might be pregnant while receiving this medicine, tell your doctor immediately.

Serious eye or vision problems (for example, retinal detachment, endophthalmitis, eye infection, increased pressure inside the eye, or neovascular AMD) may happen with this medicine. Contact your eye doctor right away if you experience blurred or any other changes in vision, eye pain, eye redness, seeing flashes or sparks of light, seeing floating spots before your eyes, or a veil or curtain appearing across part of your vision, sensitivity of the eye to light, or tearing of the eyes several days after you receive this medicine.

This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until your vision is clear.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it may provide. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how pegcetacoplan injection affects children. Its safety and effectiveness in the pediatric population have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of pegcetacoplan injection in this age group.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, but in other cases, two different medicines can be used together even if there might be an interaction. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect your ability to use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Increased pressure in the eye or
• Neovascular (wet) age-related macular degeneration (AMD)—Use with caution. This may worsen these conditions.

• Eye infection or
• Active eye swelling—Should not be used in patients with these conditions.

Along with its needed effects, Pegcetacoplan (Intraocular) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bloody eye
• Eye pain
• Painful irritation of the clear front part of the eye
• Redness of the eye

Less common

• Blindness
• Blurred or change in vision
• Seeing flashes or sparks of light
• Seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• Sensitivity of the eye to light
• Tearing

Rare

• Headache
• Red or bloodshot eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to pegcetacoplan. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Feeling like something is in the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Syfovre

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

An ophthalmologist (eye doctor) will give you this medicine as a shot into the eye. This medicine is usually given once every 25 to 60 days.