Brolucizumab is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with certain types of eye disorders, new blood vessels grow under the retina where they leak blood and fluid.

Brolucizumab ophthalmic (for the eyes) is used to treat the "wet form" of age-related macular degeneration.

Brolucizumab ophthalmic may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Brolucizumab is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Brolucizumab is usually given once per month for 3 months, and then once every 8 to 12 weeks.

Follow your doctor's dosing instructions very carefully. The timing of your monthly injections is very important for this medication to be effective.

Usual Adult Dose for Macular Degeneration:

Initial dose: 6 mg by intravitreal injection once a month for the first 3 doses
Maintenance dose: 6 mg by intravitreal injection once every 8 to 12 weeks

Comments:
-This drug should be administered by a qualified physician.
-Once monthly injections should be administered approximately every 25 to 31 days.
-In clinical trials, the maintenance dosing interval was guided by visual and anatomical measures of disease activity; the utility of these measures has not been established.

Use: For the treatment of neovascular (wet) age-related macular degeneration (AMD).

You should not use brolucizumab if you are allergic to it, or if you have:

• inflammation inside your eye; or

• an infection in or around your eye.

Tell your doctor if you have ever had:

• glaucoma;

• cataracts; or

• a stroke.

Do not use brolucizumab if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are receiving brolucizumab ophthalmic and for at least 1 month after your last dose.

Do not breastfeed while receiving this medicine, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your brolucizumab injection.

Since brolucizumab ophthalmic is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Brolucizumab ophthalmic may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;

• discharge or bleeding from the eye;

• seeing "floaters" in your vision;

• increased sensitivity to light;

• decreased vision, tunnel vision, or seeing halos around lights; or

• sudden numbness or weakness, problems with speech or balance.

Common side effects of brolucizumab ophthalmic may include:

• blurred vision, hazy vision;

• increased sensitivity to light;

• eye pain; or

• seeing floaters.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.