Vabysmo: Uses, Side Effects and Dosage

What VABYSMO is used for:

• VABYSMO is a medicine that is injected into the eye by your doctor to treat eye disorders called

  • neovascular (wet) age-related macular degeneration (AMD)
  • diabetic macular edema (DME)
  • macular edema secondary to retinal vein occlusion (RVO)

How VABYSMO works:

VABYSMO specifically recognizes and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. In conditions like wet AMD, DME, and RVO, these proteins can be present at high levels, and this can cause the growth of abnormal blood vessels, damage to the normal vessels and/or blockage of the blood vessels. These changes to the blood vessels can result in leakage into the retina causing swelling or damage to the retina, which can worsen your vision. By attaching to these proteins, VABYSMO can block their actions and prevent abnormal vessel growth, leakage, swelling and blockage. VABYSMO may improve disease and/or slow down worsening of the disease meaning it can maintain or even improve your vision.

The ingredients in VABYSMO are:

Medicinal ingredient(s): faricimab

Non-medicinal ingredients: acetic acid 30%, D-sucrose, L-histidine, L-methionine, polysorbate 20, sodium chloride, water for injections.

VABYSMO comes in the following dosage form(s):

Solution for intravitreal injection in single-use pre-filled syringe or single-use vial.

Pre-filled Syringe: A single-use glass pre-filled syringe contains 21 mg faricimab in 0.175 mL solution. This provides a usable amount to deliver a single dose of 0.05 mL solution containing 6 mg of faricimab.

Vial: A single-use glass vial contains 28.8 mg faricimab in 0.24 mL solution. This provides a usable amount to deliver a single dose of 0.05 mL solution containing 6 mg of faricimab.

Do not use VABYSMO if:

• you have an active or suspected infection in or around the eye.
• you have pain or redness in your eye (eye inflammation).
• you are allergic to faricimab or any of the other ingredients in VABYSMO (see “The ingredients in VABYSMO are”).

If any of these apply to you, tell your doctor. You should not be given VABYSMO.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VABYSMO. Talk about any health conditions or problems you may have, including if you:

• have glaucoma (an eye condition usually caused by high pressure in the eye).
• have a history of seeing flashes of light or floaters (dark floating spots) and if you have a sudden increase in the size and number of floaters.
• have had eye surgery in the last four weeks or if eye surgery is planned in the next four weeks.
• have ever had any eye diseases or eye treatments.
• have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding).

• are pregnant or planning to become pregnant.

• are breastfeeding.

During treatment with VABYSMO, tell your doctor immediately if you:

• develop signs of detachment or tear of the retina at the back of the eye, such as sudden vision loss, flashing lights and black spots.
• develop signs of a possible eye infection or inflammation, such as redness of the eye or worsening redness of the eye, eye pain, increased eye discomfort, blurred or decreased vision, an increased number of small particles in your vision, increased sensitivity to light.
• develop signs of a possible retinal vasculitis (inflammation of the vessels of the retina) and/or retinal occlusive vasculitis (blockage in a vein that drains blood from your retina), such as blurred or decreased vision, an increased number of small particles in your vision, eye pain, redness of the eye or worsening redness of the eye, increased eye discomfort, or black spots in your vision.
• develop signs of a cataract (clouding of the lens of the eye), such as clouded, blurred or dim vision.
• develop signs of a possible allergic reaction (for example, fast pulse, low blood pressure, sweating, allergic skin reactions such as rash, itching or stinging).

Other warnings you should know about:

• The safety and efficacy of VABYSMO given to both eyes at the same time has not been studied and use in this way may lead to an increased risk of experiencing side effects.
• Injections with VABYSMO may cause a temporary increase in eye pressure (intraocular pressure) in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
• Your doctor will check whether you have other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear), in which case VABYSMO must be given with caution.
• The use of vascular endothelial growth factor inhibitors, substances similar to those contained in VABYSMO, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. There could be a risk of such events following injection of VABYSMO into the eye.

Children and adolescents (< 18 years)

VABYSMO is NOT used in children and adolescents.

Pregnancy, breastfeeding and contraception

VABYSMO has not been studied in pregnant women. VABYSMO should be avoided during pregnancy unless the potential benefit to the patient outweighs the potential risk to the unborn child. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting VABYSMO treatment.

Breastfeeding is not recommended during treatment with VABYSMO because it is not known whether VABYSMO passes into human milk. A risk to the breastfed child cannot be excluded. You should not breastfeed your child during VABYSMO treatment, and for at least one month after the last injection when stopping treatment with VABYSMO. Ask your doctor for advice before starting VABYSMO treatment. A decision must be made whether to discontinue breastfeeding or to abstain from VABYSMO therapy.

Women who could become pregnant must use an effective method of birth control during treatment and for at least three months after stopping treatment with VABYSMO. If you become pregnant or think you are pregnant during treatment, tell your doctor right away.

Driving and using machines

After your injection with VABYSMO, you may have temporary vision problems (for example, blurred vision). Do not drive or use machines as long as these last.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take VABYSMO:

• VABYSMO is injected into your eye (intravitreal injection) by a doctor experienced in giving eye injections.
• Before the injection, your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your doctor will give you an eye drop (local anesthetic) to numb the eye to reduce or prevent pain from the injection.

Usual dose:

The recommended dose is 6 mg of faricimab.

Your doctor will determine how often you will need to get an injection.

wet AMD

• You will be treated with one injection every month for the first 4 months.
• After that, you may receive injections up to every 4 months. Your doctor will determine how often you will need treatment (your treatment interval) based on the condition of your eye.

DME

• You will be treated with one injection every month for the first 4 months.
• After that, you may receive injections up to every 4 months. Your doctor will determine how often you need treatment (your treatment interval) based on the condition of your eye.

RVO

• You will be treated with one injection every month until your eyesight gets better and is stable. After that, you may receive injections up to every 4 months. Your doctor will determine how often you need treatment (your treatment interval) based on the condition of your eye.

Your doctor will regularly monitor your condition to check that the treatment is working for you. Your doctor may also check your eyes during a visit and not give you an injection.

Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision loss and your vision may worsen.

If you have any further questions on the use of this medicine, ask your doctor.

Overdose:

If you think you, or a person you are caring for, have taken too much VABYSMO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose, schedule a new appointment with your doctor as soon as possible.

Possible side effects from using VABYSMO:

These are not all the possible side effects you may have when taking VABYSMO. If you experience any side effects not listed here, tell your healthcare professional.

The side effects with the VABYSMO injection are either from the medicine itself or from the injection procedure and they mostly affect the eye. Contact your doctor if any of the following side effects become severe.

Very common (may affect more than 1 in 10 people):

• None

Common (may affect up to 1 in 10 people):

• Cloudy lens in the eye (cataract)
• Detachment of the gel-like substance inside the eye (vitreous detachment)
• Bleeding from small blood vessels in the outer layer of the eye (conjunctival hemorrhage)
• Moving spots or dark shapes in your vision (vitreous floaters)
• Eye pain

Uncommon (may affect up to 1 in 100 people):

• Eye discomfort
• Itching (eye pruritus)
• Red eye (ocular/conjunctival hyperemia)
• A feeling of having something in the eye (foreign body sensation in eye)
• Pain during the procedure (procedural pain)
• Increased tear production (lacrimation increased)
• Scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion)
• Eye irritation

Rare (may affect up to 1 in 1000 people):

• Temporary decreased sharpness of vision (visual acuity reduced transiently)

Serious side effects and what to do about them

* There is a potential risk of Arterial Thromboembolic Events (ATEs), including stroke, following injection of VABYSMO into the eye.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Keep out of reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C to 8°C).
• Do not freeze. Do not shake.
• Keep the sealed tray containing the pre-filled syringe or vial in the outer carton in order to protect from light.
• Prior to use, the sealed tray containing the pre-filled syringe or unopened vial may be kept at room temperature (up to 25°C), in the original carton, for up to 24 hours.
• VABYSMO is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

If you want more information about VABYSMO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.rochecanada.com; or by calling 1-888-762-4388.

Date of Authorization: July 25, 2025

^©Copyright 2025, Hoffmann-La Roche Limited

VABYSMO® is a registered trademark of F. Hoffmann-La Roche AG, used under license

Hoffmann-La Roche Limited

Mississauga, ON L5N 5M8