Prospect: information for the patient

Vabysmo 120 mg/ml injectable solution

faricimab

This medication is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to refer to it again.
• If you have any doubts, consult your doctor.
• If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

Vabysmo contains the active ingredient faricimab, which belongs to a group of medicines called anti-neovascular agents.

Vabysmo is injected into the eye by your doctor to treat eye disorders in adults called:

• age-related macular degeneration with neovascular (exudative) complications (AMDn),
• vision impairment due to diabetic macular edema (DME).
• vision impairment due to macular edema caused by retinal vein occlusion (branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)).

These disorders affect the macula, the central part of the retina (the light-sensitive layer at the back of the eye) responsible for fine and central vision. AMDn is caused by the growth of abnormal blood vessels that allow blood and fluid to leak into the macula, and DME is caused by leaky blood vessels that cause macular swelling. CRVO is the blockage of the main blood vessel (vein) that carries blood from the retina, and BRVO is the blockage of one of the smaller branches of the main vein. Due to the increase in pressure within the veins, there is a leakage of fluid into the retina, causing macular swelling (macular edema).

How Vabysmo works

Vabysmo specifically recognizes and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present at higher-than-normal levels, they can cause the growth of abnormal blood vessels and/or damage to normal blood vessels, with leakage into the macula, causing swelling or damage that can negatively affect a person's vision. By binding to these proteins, Vabysmo can block their actions and prevent abnormal blood vessel growth, leakage, and swelling. Vabysmo can improve the disease and/or slow its progression, thereby maintaining or even improving your vision.

Do not use Vabysmo:

• if you are allergic to faricimab or any of the other components of this medication (listed in section 6).
• if you have an active infection or suspect one in your eye or around it.
• if you have eye pain or redness (ocular inflammation).

If you find yourself in any of these situations, inform your doctor. Do not administer Vabysmo.

Warnings and precautions

Consult your doctor before starting to use Vabysmo:

• if you have glaucoma (a generally high-pressure eye disease).
• if you have a history of seeing flashes, lights, or floating particles (black spots) and if you have a sudden increase in the size and number of floating particles.
• if you have had eye surgery in the last 4 weeks or if eye surgery is planned in the next 4 weeks.
• if you have ever had any eye disease or eye treatment.

Consult your doctor immediately if:

• you experience sudden vision loss.
• you experience signs of possible eye infection or inflammation, such as worsening eye redness, eye pain, increased eye discomfort, blurry or decreased vision, an increase in the number of small particles in your vision, increased sensitivity to light.

Also, be aware that:

• the safety and efficacy of Vabysmo when administered in both eyes at the same time have not been studied and using it in this way may increase the risk of experiencing adverse effects.
• injections with Vabysmo may cause a temporary increase in eye pressure (intraocular pressure) in some patients within 60 minutes after the injection. Your doctor will monitor this after each injection.
• Your doctor will check if you have other risk factors that may increase the likelihood of retinal detachment or retinal tear (retinal detachment or tear, and pigment epithelial detachment of the retina), in which case Vabysmo will be administered with caution.

When some medications similar to Vabysmo are administered, there is a known risk of blood clots that block blood vessels (arterial thromboembolic events), which can cause a heart attack or stroke. Since a small amount of the medication enters the bloodstream, there is a theoretical risk of these episodes after Vabysmo injection into the eye.

The experience is limited in the treatment of:

• patients with active infections.
• patients with diabetic macular edema (DMAE) and patients with retinal vein occlusion (RVO) aged 85 years and older.
• patients with edema of the macula due to diabetes type I.
• diabetics with high average blood sugar levels (glycosylated hemoglobin above 10%).
• diabetics with diabetic eye disease, known as proliferative diabetic retinopathy.
• diabetics with high blood pressure, above 140/90 mmHg and vascular disease.
• patients with edema of the macula who receive injections at intervals less than 8 weeks for a long period of time.

The experience is limited in the treatment of patients who receive injections at intervals less than 8 weeks for a long period of time and these patients may have a higher risk of adverse effects.

There is no experience in the treatment of:

• uncontrolled high blood pressure in diabetics or patients with RVO.

If any of the above happens, your doctor will take this lack of information into account when treating you with Vabysmo.

Children and adolescents

Vabysmo has not been studied in children and adolescents because diabetic macular edema, edema of the macula, and RVO primarily occur in adults.

Other medications and Vabysmo

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and lactation

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 unborn child.

If you are pregnant or breastfeeding, consult your doctor before using this medication.

It is not recommended to breastfeed during treatment with Vabysmo because it is unknown whether Vabysmo is excreted in human milk.

Women who may become pregnant should use an effective contraceptive method during treatment and for at least three months after stopping treatment with Vabysmo. If you become pregnant or think you may be pregnant during treatment, inform your doctor immediately.

Driving and operating machines

After Vabysmo injection, you may experience temporary vision problems (e.g., blurry vision). Do not drive or operate machines while these last.

Vabysmo contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Vabysmo contains polysorbate

This medication contains 0.02 mg of polysorbate in each 0.05 ml dose. Polysorbates can cause allergic reactions. Consult your doctor if you have any known allergies.

How Vabysmo is administered

The recommended dose is 6mg of faricimab.

Age-related macular degeneration associated with neovascular (exudative) (AMDn)

• You will be administered an injection every month for the first 3 months.
• Subsequently, you should receive injections every 4months. Your doctor will determine the frequency of injections based on the condition of your eye.

Diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO))

•You will be administered an injection every month for a minimum of 3months.

•Subsequently,you may receive injections less frequently.Your doctor will determine the frequency of injections based on the condition of your eye.

Administration form

Vabysmo is injected into the eye (intravitreal injection) by an experienced doctor in administering ocular injections.

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

How long the Vabysmo treatment lasts

This is a long-term treatment, possibly continuing for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. Depending on how you respond to Vabysmo treatment, your doctor will perform a change to a higher or lower dose frequency.

What to do if you miss a Vabysmo dose

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

What to do if you interrupt Vabysmo treatment

Speak with your doctor before interrupting treatment. Interrupting treatment may increase the risk of vision loss and your vision may worsen.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of Vabysmo injections are both due to the medicine and the injection procedure and can mainly affect the eye.

Some side effects can be serious

Contact your doctorimmediately if you have any of the following symptoms, which are signs of allergic reactions, inflammation, or infections:

• Eye pain, increased discomfort, worsening of eye redness, blurred or decreased vision, increased number of small particles in your vision, increased sensitivity to light – these are signs of possible eye infection, inflammation, or allergic reaction.
• A sudden decrease or change in vision.

Other possible side effects

Other side effects that may occur after treatment with Vabysmo include those listed below.

Many of the side effects are mild or moderate and will usually disappear within a week after each injection.

Contact your doctor if any of the following side effects become severe.

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

• None

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

• Cataract (clouding of the lens in the eye)
• Retinal pigment epithelium tear (only in DMAEn)
• Vitreous detachment
• Intraocular pressure increase
• Conjunctival hemorrhage
• Floaters in the vitreous
• Eye pain

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

• Endophthalmitis (severe inflammation or infection within the eye)
• Vitritis (inflammation of the vitreous gel in the eye/eye redness)
• Iritis, iridocyclitis, uveitis (inflammation of the iris and its adjacent tissue in the eye)
• Vitreous hemorrhage
• Eye discomfort
• Pruritus (itching of the eye)
• Retinal tear (part of the posterior eye that detects light)
• Eye redness (ocular/conjunctival hyperemia)
• Sensation of something in the eye
• Blurred vision
• Reduced visual acuity
• Pain during the procedure
• Retinal detachment
• Increased tear production (excessive lacrimation)
• Corneal abrasion, damage to the transparent part of the eyeball that covers the iris (corneal abrasion)
• Ocular irritation

Rare(may affect up to 1 in 10,000people):

• Temporary reduction in visual acuity (transiently reduced visual acuity)
• Cataract due to trauma (traumatic cataract)

Frequency not known

• Retinal vasculitis (inflammation of the blood vessels in the back of the eye)
• Retinal occlusive vasculitis (blockage of the blood vessels in the back of the eye, usually with inflammation)

When some medicines that work similarly to Vabysmo are administered, it is known that there is a risk of blood clots that block blood vessels (arterial thromboembolic events) that can cause a heart attack or stroke. Since a small amount of the medicine enters the bloodstream, there is a theoretical risk of these episodes after Vabysmo injection into the eye.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V*.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Your doctor, pharmacist, or nurse is responsible for conserving this medication and disposing of any unused product correctly. The following information is intended for healthcare professionals.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging after EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (2°C-8°C).

Do not freeze.

Store in the outer packaging to protect it from light.

Before use, the unopened vial can be stored at room temperature, from 20°C to 25°C, for up to 24hours.

Composition of Vabysmo

• The active ingredient is faricimab. One milliliter of solution contains 120 mg of faricimab. Each vial contains 28.8 mg of faricimab in 0.24 ml of solution. This provides a usable dose to release a single dose of 0.05 ml of solution containing 6 mg of faricimab.
• The other components are: L-histidine, acetic acid at 30% (E 260), L-methionine, sodium chloride, sucrose, polisorbate 20 (E 432), water for injectable preparations (see Section 2 “Vabysmo contains sodium and polisorbate”).

Appearance of the product and contents of the package

Vabysmo is a clear to opalescent, transparent to yellowish-brown solution.

The package contains a glass vial and a sterile blunt cannula with a filter (caliber 18 x 1½ inches, 1.2 mm x 40 mm, 5 μm) for single use.

Holder of the marketing authorization and responsible for manufacturing

Roche Registration GmbH

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

• This information is intended only for healthcare professionals:
• Instructions for use of the vial:

Figure A

Assemble the components: