Pronunciation:

peg-set-a-KOE-plan

Brand Names:

• Syfovre

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Uses of This Medicine:

Pegcetacoplan injection is used to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurred vision or blindness. Pegcetacoplan works by changing the amount of blood that gets to the eye.

This medicine is to be given only by your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pegcetacoplan injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegcetacoplan injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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. May make these conditions worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 40 days after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Serious eye or vision problems (eg, retinal detachment, endophthalmitis, eye infection, increased pressure inside the eye, neovascular AMD, retinal vasculitis, or retinal vascular occlusion) may occur with this medicine. Check with your eye doctor right away if your have blurred or other change in vision, eye pain, eye redness, 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, 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 you can see clearly.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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 the medicine. 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.