Pronunciation:

far-IK-i-mab - svoa

Brand Names:

• Vabysmo

Dosage Forms:

• Solution

Classifications:

Pharmacologic—

Faricimab

Uses of This Medicine:

Faricimab-svoa 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. Faricimab-svoa works by changing the amount of blood that gets to the eye.

Faricimab-svoa 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 or under the direct supervision of 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 faricimab-svoa 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 faricimab-svoa 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:

• 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 every 4 weeks (about every 28 days) for at least 4 doses. Some patients may receive additional doses every 4 weeks after the first 4 injections.

Precautions While Using This Medicine:

Your eye doctor will want to check your progress 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 3 months 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 or retinal detachment) 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 are having pain in your chest, groin, or legs, especially the calves, difficulty or trouble breathing, a severe, sudden headache, slurred speech, sudden loss of coordination, sudden, 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

Bloody eye

redness of the eye

Less common

Blurred vision

change in vision

eye pain

loss of vision

red, sore eyes

seeing floaters, veil or curtain appearing across part of vision

seeing floating dark spots or material before the eyes

tearing

Rare

Eye irritation

seeing light flashes

watering of the eyes

Incidence not known

Chest pain, discomfort, or tightness

fast heartbeat

fever

hives, itching, rash

hoarseness

irritation

joint pain, stiffness, or swelling

nausea

pain or discomfort in the arms, jaw, back, or neck

redness of the skin

stroke

sweating

swelling of the eyelids, face, lips, hands, or feet

trouble breathing

vomiting

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.