Vabysmo contains the active substance faricimab, which belongs to a class of medicines called antineovascularisation medicines.
Vabysmo is injected into the eye by your doctor in adults to treat eye conditions called:
• age-related macular degeneration (AMD), neovascular (wet) form,
• visual acuity impairment caused by diabetic macular edema (DME)
• visual acuity impairment caused by macular edema secondary to retinal vein occlusion (branch retinal vein occlusion [BRVO] or central retinal vein occlusion [CRVO])

These conditions affect the macula, the central part of the retina (the light-sensitive layer at the back of the eye) that is responsible for fine, central vision. Neovascular (wet) AMD is caused by the growth of abnormal blood vessels that leak blood or fluid into the macula, and AMD is caused by leakage from blood vessels, causing the macula to swell. OVCR is obstruction of the main blood vessel (vein) that carries blood out of the retina, and ORVR is obstruction of one of the smaller branches of the main vein. Because of the increased pressure inside these blood vessels, fluid leaks from them into the retina, causing swelling of the macula (macular edema).

How Vabysmo works:
Vabysmo specifically recognises and blocks the activity of proteins called angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present in amounts that exceed normal levels, they cause abnormal blood vessels to grow and/or damage normal blood vessels, with leakage from them into the macula, causing swelling or damage to the macula, which can negatively affect a person’s vision. By attaching to these proteins, Vabysmo can block their activity and prevent the abnormal blood vessel growth, leakage and inflammation. Vabysmo can improve your disease and/or slow down the progression of the disease and thus maintain or even improve your vision.

You should not be given Vabysmo:
• if you are allergic to faricimab or any of the other ingredients of this medicine.

Talk to your doctor before you are given Vabysmo.

Pregnancy and breastfeeding:
Vabysmo has not been studied in pregnant women. Vabysmo should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Breastfeeding is not recommended during treatment with Vabysmo, as it is not known whether Vabysmo passes into human milk.

Women who could become pregnant must use effective contraception during treatment and for at least three months after stopping Vabysmo. If you become pregnant or think you may be pregnant during treatment, tell your doctor immediately.

Driving and using machinery:
After the injection of Vabysmo you may have temporary vision problems (for example, blurred vision). Do not drive or use machines while these problems persist.

Vabysmo contains sodium:
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Vabysmo contains polysorbate:
This medicine contains polysorbate 0.02 mg per 0.05 ml dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

The recommended dose is 6 mg of faricimab.

Age-related macular degeneration (AMD), neovascular (wet) form
• You will be given one injection every month for the first 4 months.
• After that, you may have injections every 4 months. Your doctor will decide how often you should have the injections, depending on the condition of your eye.

Impaired visual acuity due to diabetic macular edema (DME)
• You will be given one injection every month for the first 4 months.
• After that, you may have injections every 4 months. Your doctor will decide how often you should have the injections, depending on the condition of your eye.

Visual impairment due to macular edema secondary to retinal vein occlusion (branch retinal vein occlusion [BRVO] or central retinal vein occlusion [CRVO])
• You will be given one injection every month for at least 3 months.
• After that, you may receive injections less frequently. Your doctor will determine how often you should receive injections, depending on the condition of your eye.

Method of administration:
Vabysmo is given as an injection into the eye (intravitreal injection) by a doctor experienced in giving intraocular injections.

Before giving the injection, your doctor will use an eye disinfectant to carefully clean your eye to prevent infection. Your doctor will give you some eye drops (a local anesthetic) to numb your eye and reduce or prevent pain from the injection.

How long does treatment with Vabysmo last?
This is a long-term treatment that may be continued for several months or years.
Your doctor will monitor you regularly to check that the treatment is working. Depending on how you respond to Vabysmo, your doctor may ask you to come in more or less often for your dose.

• The active substance is faricimab. One ml of solution for injection contains 120 mg of faricimab. Each pre-filled syringe contains 21 mg of faricimab in 0.175 ml of solution. This provides a usable amount for the administration of a single dose of 0.05 ml of solution, containing 6 mg of faricimab.
• The other ingredients are: L-histidine, acetic acid 30% (E 260), L-methionine, sodium chloride, sucrose, polysorbate 20 (E 432), water for injections (see section 2 “Vabysmo contains sodium and polysorbate”).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

1 pre-filled syringe