Pronunciation:

broe-lue-SIZ-ue-mab - dbll

Brand Names:

• Beovu

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Brolucizumab

Uses of This Medicine:

Brolucizumab-dbll injection is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurring of vision or blindness. Brolucizumab-dbll works by changing the amount of blood that gets to the eye.

Brolucizumab-dbll injection is also used in diabetic patients who have diabetic macular edema (DME). Macular edema can cause loss of vision.

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—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of brolucizumab-dbll 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 brolucizumab-dbll 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:

• Blood clots, history of or
• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Glaucoma (increased pressure in the eye) or
• Heart attack, history of or
• Stroke, history of—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.

Neovascular (wet) age-related macular degeneration (AMD): This medicine is usually given every month (about every 25 to 31 days) for the first 3 doses, followed by once every 8 to 12 weeks.

Diabetic macular edema (DME): This medicine is usually given every 6 weeks (every 39 to 45 days) for the first 5 doses, followed by once every 8 to 12 weeks.

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 1 month 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, eye infection, increased pressure in the eye, or retinal detachment, vasculitis, or vascular blockage) 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, headache, seeing flashes or sparks of light, seeing floating spots before the eyes, or a veil or curtain appearing across part of vision, or tearing of the eyes several days after you receive this medicine. Also, tell your eye doctor if you feel increased pressure in your eye.

This medicine may increase your risk of blood clots, heart attack, or stroke. Check with your doctor right away if you have pain in your chest, groin, or legs, especially the calves, difficulty with breathing, a severe, sudden headache, slurred speech, a sudden loss of coordination, severe weakness or numbness in your arm or leg, or vision changes.

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

Blindness

bloody eye

blurred vision

decreased vision

redness of the eye

Less common

Burning, dry, or itching eyes

discharge, excessive tearing

headache

other changes in vision

painful irritation of the clear front part of the eye

redness of the white part of the eyes or inside of the eyelids

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

tearing of the eyes

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:

Less common

Seeing floating dark spots or material before eyes

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.