Vabysmo

Package leaflet: Information for the patient

Vabysmo 120 mg/mL solution for injection in pre-filled syringe

faricimab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

In addition to this package leaflet, your doctor will provide you with a patient guide for you or your caregiver that contains important safety information to help you understand the benefits and risks associated with Vabysmo and the actions to take in case of specific symptoms.
Contents of this leaflet

1. What Vabysmo is and what it is used for
2. What you need to know before receiving Vabysmo
3. How to use Vabysmo
4. Possible side effects
5. How to store Vabysmo
6. Contents of the pack and other information

1. What Vabysmo is and what it is used for

What Vabysmo is and what it is used for
Vabysmo contains the active substance faricimab, which belongs to a group of medicines called
anti-angiogenic agents.
Vabysmo is injected into the eye by a doctor to treat the following eye conditions in adults:

• neovascular (wet) age-related macular degeneration (neovascular Age-related Macular Degeneration, nAMD);
• vision loss caused by diabetic macular oedema (Diabetic Macular Oedema, DME);
• vision loss caused by macular oedema secondary to retinal vein occlusion (Retinal Vein Occlusion, RVO; branch RVO or central RVO).

These diseases affect the macula, the central part of the retina (the light-sensitive layer located at the back of the eye), which is responsible for sharp central vision. nAMD is caused by the growth of abnormal blood vessels that leak blood and fluid into the macula, while DME is caused by leaky blood vessels leading to swelling of the macula. Central RVO is caused by blockage of the main blood vessel (vein) that carries blood away from the retina, whereas branch RVO is caused by blockage in one of the smaller branches of this main vein. Due to increased pressure within these blood vessels, fluid leakage occurs in the retina, resulting in swelling of the macula (macular oedema).

How Vabysmo works
Vabysmo specifically recognizes and blocks the activity of two proteins called angiopoietin-2 and vascular endothelial growth factor A. When present in higher than normal amounts, these proteins can cause the growth of abnormal blood vessels and/or damage healthy vessels, leading to fluid leakage into the macula. This results in swelling or damage that can negatively affect vision. By binding to these proteins, Vabysmo blocks their actions and helps prevent the growth of abnormal blood vessels, fluid leakage, and swelling. Vabysmo can improve the disease and/or slow its progression, thereby helping to maintain or even improve vision.

2. What you need to know before receiving Vabysmo

Do not receive Vabysmo:

• if you are allergic to faricimab or to any of the other ingredients of this medicine (listed in section 6);
• if you have an active or suspected infection inside or around the eye;
• if you experience eye pain or redness (ocular inflammation).

If any of these situations apply to you, inform your doctor. Vabysmo must not be administered to you.
Warnings and precautions
Talk to your doctor before receiving Vabysmo:

• if you have glaucoma (an eye condition usually caused by high pressure inside the eye);
• if you have previously experienced flashes of light or floaters (floating black spots), or if you notice a sudden increase in the size or number of floaters;
• if you have had eye surgery in the past 4 weeks or if eye surgery is planned within the next 4 weeks;
• if you have previously had eye diseases or have undergone eye treatments.

Inform your doctor immediately:

• if you develop sudden vision loss;
• if you develop signs of a possible eye infection or inflammation, such as increased eye redness, eye pain, increased eye discomfort, blurred or reduced vision, increased number of small particles in your field of vision, or increased sensitivity to light.

You should also be aware of the following:

• the safety and efficacy of Vabysmo when administered in both eyes simultaneously have not been studied, and this type of use may increase the risk of adverse effects;
• in some patients, Vabysmo injections may cause a temporary increase in intraocular pressure within 60 minutes after injection. Your doctor will monitor this condition after each injection;
• your doctor will assess whether you have other risk factors that could increase the likelihood of a tear or detachment of one of the layers located at the back of the eye (retinal detachment or tear, or retinal pigment epithelial detachment or tear), in which case Vabysmo should be administered with caution.

When certain medicines that act similarly to Vabysmo are administered, there is a known risk of blood clots forming and blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. Since small amounts of the medicine may enter the bloodstream after an intraocular injection of Vabysmo, there is a theoretical risk of developing such events.
Limited experience exists in treating:

• patients with active infections;
• patients with nAMD and RVO aged 85 years or older;
• patients with DME due to type I diabetes;
• diabetic patients with high average blood sugar levels (HbA1c above 10%);
• diabetic patients with a diabetes-related eye disease called proliferative diabetic retinopathy;
• diabetic patients with high blood pressure above 140/90 mmHg and blood vessel disease;
• patients with DME receiving treatments at intervals longer than 8 weeks between injections over a prolonged period.

There is limited experience in treating patients receiving treatments at intervals longer than 8 weeks between injections over a prolonged period, and these patients may be at higher risk of developing adverse effects.
There is no experience in treating:

• diabetic patients or patients with RVO who have uncontrolled hypertension.

If any of the above conditions apply to you, your doctor will take into account the lack of available information during your treatment with Vabysmo.
Children and adolescents
The use of Vabysmo in children and adolescents has not been studied, as nAMD, DME, and RVO primarily occur in adults.
Other medicines and Vabysmo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
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, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before receiving this medicine.
Breastfeeding is not recommended during treatment with Vabysmo, as it is unknown whether this medicine passes into breast milk.
Women who could become pregnant should use an effective method of contraception during treatment and for at least three months after stopping treatment with Vabysmo. If you become pregnant or suspect pregnancy during treatment, inform your doctor immediately.
Driving and use of machines
After receiving a Vabysmo injection, you may experience temporary vision problems (e.g., blurred vision). Do not drive or operate machinery until these symptoms resolve.
Vabysmo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”.
Vabysmo contains polysorbate
This medicine contains 0.02 mg of polysorbate per 0.05 mL dose. Polysorbate may cause allergic reactions. Inform your doctor if you have allergies.

3. How to use Vabysmo

How Vabysmo is administered
The recommended dose is 6 mg of faricimab.
Neovascular (wet) age-related macular degeneration (nAMD)

• You will be treated with one injection per month for the first 4 months.
• Afterwards, you may receive injections up to once every 4 months. Based on the condition of your eye, your doctor will decide the frequency of injections.

Vision impairment due to diabetic macular oedema (DME)

• You will be treated with one injection per month for the first 4 months.
• Afterwards, you may receive injections up to once every 4 months. Based on the condition of your eye, your doctor will decide the frequency of injections.

Vision impairment due to macular oedema secondary to retinal vein occlusion
(branch RVO or central RVO)

• You will be treated with one injection per month for at least 3 months.
• Afterwards, injections may be given less frequently. Based on the condition of your eye, your doctor will decide the frequency of injections.

Method of administration
Vabysmo is injected into the eye (intravitreal injection) by a doctor experienced in administering this type of injection.
Before the injection, your doctor will use a disinfecting eye wash to carefully clean the eye in order to prevent infection. Your doctor will also apply eye drops (local anaesthetic) to numb the eye, thereby reducing or preventing injection-related pain.

Duration of treatment with Vabysmo
This is a long-term treatment that may continue for months or years. Your doctor will regularly monitor your condition to check that the treatment is working. Depending on your response to Vabysmo, your doctor may adjust the dosing frequency, increasing or decreasing it as needed.

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

If you stop treatment with Vabysmo
Talk to your doctor before stopping treatment. Discontinuing treatment may increase the risk of vision loss, and your vision may worsen.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Vabysmo injection are due to either the medicine or the injection procedure and mainly affect the eye.

Some side effects could be serious
Contact your doctor immediately if you experience any of the following side effects, which are signs of allergic reactions, inflammation or infections:

• eye pain, increased discomfort, increased eye redness, blurred or reduced vision, increased number of small particles in the visual field, or increased sensitivity to light – these are signs of a possible eye infection or inflammation, or an allergic reaction;
• sudden reduction or change in vision.

Other possible side effects
Other side effects that may occur after treatment with Vabysmo include those listed below.
Most of these side effects are mild to moderate in intensity and usually resolve within one week after each injection.
Contact your doctor if any of the following side effects worsen.

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

• None

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

• clouding of the eye's lens (cataract)
• tear in one of the layers located at the back of the eye (retinal pigment epithelial tear – only in nAMD)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• increased pressure inside the eye (increased intraocular pressure)
• bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage)
• moving spots or dark shapes in the visual field (floaters in the vitreous)
• eye pain

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

• severe inflammation or infection inside the eye (endophthalmitis)
• inflammation of the gel-like substance inside the eye/red eye (vitritis)
• inflammation of the iris and adjacent tissue in the eye (iritis, iridocyclitis, uveitis)
• bleeding inside the eye (vitreous haemorrhage)
• eye discomfort
• itching (ocular pruritus)
• retinal tear (tear in the light-sensitive back part of the eye)
• red eye (ocular/conjunctival hyperaemia)
• sensation of a foreign body in the eye
• blurred vision
• reduced visual acuity (reduced visual acuity)
• pain during the procedure (procedural pain)
• retinal detachment
• increased tear production (epiphora)
• corneal scratch, damage to the transparent layer covering the iris (corneal abrasion)
• eye irritation

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

• temporary reduction in visual acuity (transiently reduced visual acuity)
• lens opacity due to injury (traumatic cataract)

Not known

• retinal vasculitis (inflammation of blood vessels in the back of the eye)
• occlusive retinal vasculitis (blockage of blood vessels in the back of the eye, typically occurring with inflammation)

When medicines similar to Vabysmo are administered, there is a known risk that blood clots may block blood vessels (arterial thromboembolic events), which could lead to heart attack or stroke. Since small amounts of the medicine enter the bloodstream, there is a theoretical risk of such events occurring after Vabysmo injection into the eye.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vabysmo

The doctor, pharmacist, or nurse is responsible for the storage of this medicinal product and
for the correct disposal of unused product. The following information is intended for
healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and label after
Exp/EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C).
Do not freeze.
Keep the tray sealed in the original packaging to protect the pre-filled syringe from light.
The pre-filled syringe may be stored at room temperature, between 20 °C and 25 °C, in the
original packaging for a maximum of 24 hours.

6. Package contents and other information

What Vabysmo contains

• The active substance is faricimab. 1 mL of injectable solution contains 120 mg of faricimab. Each pre-filled syringe contains 21 mg of faricimab in 0.175 mL of solution. This provides a sufficient amount for administration of a single dose of 0.05 mL solution containing 6 mg of faricimab.
• The other components 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 “Vabysmo contains polysorbate”).

Description of the appearance of Vabysmo and contents of the pack
Vabysmo 120 mg/mL solution for injection (injection) in a pre-filled syringe is a solution ranging from clear to opalescent, colourless to yellowish-brown.
Pack containing one filter needle for sterile injection, ultra-thin wall (30 gauge x 0.5 inch, 0.30 mm x 12.7 mm, 5 µm), packaged together with a single-use pre-filled syringe only.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Str 1
79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (See/siehe Belgique/Belgien)
Tel: +359 2 474 5444

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0)1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: + 385 1 47 22 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Κύπρος Sverige
Roche (Hellas) A.E. Roche AB
Τηλ: +30 210 61 66 100 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .
<-------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:

Instructions for use of the pre-filled syringe:

Before you begin

Carefully read all instructions before using Vabysmo.
The Vabysmo carton contains:

A sterile pre-filled syringe in a sealed tray. The pre-filled syringe is for single use only.

A sterile injection filter needle, extra-thin wall, 30 gauge x 0.5 inches, with an integrated filter. The injection filter needle is for single use only.
For administration, use only the injection filter needle provided,
as it has been designed to ensure the safety of ophthalmic use of the medicine.

Vabysmo must be stored in the refrigerator at temperatures between 2°C and 8°C.
Do not freeze.

Before administration, allow Vabysmo to reach room temperature (20°C–25°C).
Before administration, keep the sealed tray in the original packaging to

protect the pre-filled syringe from light. The pre-filled syringe may be stored at room temperature in the original packaging for a maximum of 24 hours.

Before administration, Vabysmo must be visually inspected.
Do not use if the carton seals have been tampered with.
Do not use if the packaging, pre-filled syringe, or injection filter needle are expired, damaged, or have been tampered with.
Do not use if the injection filter needle is missing.
Do not remove the syringe handle.
Do not use if the syringe cap is detached from the Luer Lock.
Do not use if particulate matter, cloudiness, or discoloration is visible. Vabysmo is a solution ranging from clear to opalescent, from colorless to yellowish-brown.
The carton contains

Figure A
Description of the device

Figure B
Removal of the syringe from the tray (Step 1) and all subsequent steps must be performed using aseptic technique.
Opening the tray and removing the syringe cap
1 Remove the lid from the syringe tray and, maintaining aseptic conditions, remove the pre-filled syringe.
2 Hold the syringe by the white ring; detach and remove the syringe cap ( see Figure C ).
Do not unscrew the cap.

Figure C
Attaching the injection filter needle
3 While maintaining aseptic conditions, remove the injection filter needle from its packaging.
4 While maintaining aseptic conditions, firmly attach the injection filter needle to the syringe Luer Lock ( see Figure D ).

For administration,
use only the injection
filter needle provided
Figure D
5 Carefully remove the needle cap by pulling it straight off—remove it firmly.
Removing air bubbles
6 Hold the syringe with the injection filter needle pointing upward. Check that the syringe contains no air bubbles.
7 If air bubbles are present, gently tap the syringe with a finger until the bubbles rise to the top ( see Figure E ).

Figure E
Adjusting the medicine dose and removing air
8 Hold the syringe at eye level and slowly depress the plunger rod until the lower edge of the rubber stopper dome aligns with the graduation mark indicating the 0.05 mL dose ( see Figure F ). This will expel air and excess solution, resulting in an accurate dose of 0.05 mL.
Ensure that the injection is administered immediately after dose preparation.

Figure F
Injection procedure
9 The injection procedure must be performed under aseptic conditions.
Inject slowly until the rubber stopper reaches the bottom end of the syringe to deliver the 0.05 mL volume.
Do not recap or remove the injection filter needle from the syringe.
Any unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

Patient information leaflet

Vabysmo 120 mg/mL solution for injection

faricimab
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicinal product, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

1. What Vabysmo is and what it is used for
2. What you need to know before receiving Vabysmo
3. How to use Vabysmo
4. Possible side effects
5. How to store Vabysmo
6. Contents of the pack and other information

1. What Vabysmo is and what it is used for

What Vabysmo is and what it is used for
Vabysmo contains the active substance faricimab, which belongs to a group of medicines called
anti-angiogenic agents.
Vabysmo is injected into the eye by a doctor to treat the following eye conditions in adults:

• neovascular age-related macular degeneration (neovascular Age-related Macular Degeneration, nAMD);
• vision impairment due to diabetic macular oedema (Diabetic Macular Oedema, DME);
• vision impairment due to macular oedema secondary to retinal vein occlusion (Retinal Vein Occlusion, RVO; branch RVO or central RVO).

These diseases affect the macula, the central part of the retina (the light-sensitive layer located at the back of the eye), which is responsible for sharp central vision. nAMD is caused by the growth of abnormal blood vessels that leak blood and fluid into the macula, whereas DME is caused by leaky blood vessels leading to swelling of the macula. Central RVO is caused by blockage of the main blood vessel (vein) that carries blood away from the retina, while branch RVO is caused by blockage in one of the smaller branches of the main vein. Due to increased pressure within these blood vessels, fluid leakage occurs in the retina, resulting in swelling of the macula (macular oedema).

How Vabysmo works
Vabysmo specifically recognises and blocks the activity of proteins called angiopoietin-2 and vascular endothelial growth factor A. When present in excessive amounts, these proteins can cause the growth of abnormal blood vessels and/or damage healthy vessels, leading to fluid leakage into the macula. This results in swelling or damage that can negatively affect vision. By binding to these proteins, Vabysmo can inhibit their actions and prevent the growth of abnormal blood vessels, fluid leakage, and swelling. Vabysmo may improve the disease and/or slow its progression, thereby helping to maintain or even improve vision.

2. What you need to know before receiving Vabysmo

Do not receive Vabysmo:

• if you are allergic to faricimab or to any of the other ingredients of this medicine (listed in section 6);
• if you have an active or suspected infection inside or around the eye;
• if you experience eye pain or redness (ocular inflammation).

If you are in any of these situations, inform your doctor. Vabysmo must not be administered to you.
Warnings and precautions
Talk to your doctor before Vabysmo is administered to you:

• if you have glaucoma (an eye condition usually caused by high pressure inside the eye);
• if you have previously experienced flashes of light or floaters (black spots floating in your vision), or if you notice a sudden increase in the size or number of floaters;
• if you have had eye surgery within the last 4 weeks or if eye surgery is planned within the next 4 weeks;
• if you have previously had eye diseases or have undergone eye treatments.

Inform your doctor immediately:

• if you develop sudden vision loss;
• if you develop signs of a possible eye infection or inflammation, such as increased eye redness, eye pain, increased eye discomfort, blurred or reduced vision, increased number of small particles in your visual field, or increased sensitivity to light.

It is also important for you to know the following:

• the safety and efficacy of Vabysmo when administered in both eyes simultaneously have not been studied, and this type of use may increase the risk of adverse effects;
• in some patients, Vabysmo injections may cause a temporary increase in eye pressure (intraocular pressure) within 60 minutes after injection. Your doctor will monitor your intraocular pressure after each injection;
• your doctor will assess whether you have other risk factors that could increase the likelihood of a tear or detachment of one of the layers located at the back of the eye (retinal tear or detachment, or retinal pigment epithelium tear or detachment), in which case Vabysmo should be administered with caution.

When certain medicines that work similarly to Vabysmo are administered, there is a known risk of blood clots forming and blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. Since small amounts of the medicine may enter the bloodstream after injection of Vabysmo into the eye, there is a theoretical risk of developing such events.
Limited experience exists in treating:

• patients with active infections;
• patients with nAMD and RVO aged 85 years or older;
• patients with DME due to type I diabetes;
• diabetic patients with high average blood sugar levels (HbA1c over 10%);
• diabetic patients with an eye disease caused by diabetes called proliferative diabetic retinopathy;
• diabetic patients with high blood pressure above 140/90 mmHg and blood vessel disease;
• patients with DME receiving injections less frequently than every 8 weeks over a long period of time.

There is only limited experience in treating patients receiving injections less frequently than every 8 weeks over a long period of time, and these patients may be at higher risk of developing adverse effects.
There is no experience in treating:

• diabetic patients or patients with RVO who have uncontrolled hypertension.

If any of the above conditions apply to you, your doctor will take into account the lack of information regarding these situations during treatment with Vabysmo.
Children and adolescents
The use of Vabysmo in children and adolescents has not been studied, as nAMD, DME, and RVO occur primarily in adults.
Other medicines and Vabysmo
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
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, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before receiving this medicine.
Breastfeeding is not recommended during treatment with Vabysmo, as it is unknown whether this medicine passes into breast milk.
Women of childbearing potential should use an effective method of contraception during treatment and for at least three months after stopping treatment with Vabysmo. If you become pregnant or suspect pregnancy during treatment, inform your doctor immediately.
Driving and use of machines
After injection of Vabysmo, you may experience temporary vision problems (e.g., blurred vision). Do not drive or operate machinery until these symptoms resolve.
Vabysmo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".
Vabysmo contains polysorbate
This medicine contains 0.02 mg of polysorbate per 0.05 mL dose. Polysorbate may cause allergic reactions. Inform your doctor if you have allergies.

3. How to use Vabysmo

How Vabysmo is administered
The recommended dose is 6 mg of faricimab.
Neovascular (wet) age-related macular degeneration (nAMD)

• You will receive a monthly injection for the first 3 months.
• Afterwards, you may receive injections up to once every 4 months. Based on the condition of your eye, your doctor will decide the frequency of injections.

Vision impairment due to diabetic macular edema (DME) and macular edema
secondary to retinal vein occlusion (RVO)

• You will receive a monthly injection for at least 3 months.
• Afterwards, injections may be given less frequently. Based on the condition of your eye, your doctor will decide the frequency of injections.

Method of administration
Vabysmo is injected into the eye (intravitreal injection) by a doctor experienced in
administering this type of injection.
Before the injection, the doctor will use an antiseptic eye wash to thoroughly clean the eye to help prevent infection. The doctor will also apply eye drops (local anaesthetic) to numb the eye and reduce or prevent pain caused by the injection.

Duration of treatment with Vabysmo
This is a long-term treatment which may continue for months or years. Your doctor will regularly monitor your condition to check that the treatment is working. Depending on your response to Vabysmo treatment, your doctor may adjust the frequency of administration, either increasing or decreasing it.

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

If you stop treatment with Vabysmo
Talk to your doctor before stopping treatment. Stopping treatment may increase the risk of vision loss and your vision could worsen.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects of Vabysmo injections are due either to the medicine itself or to the injection procedure, and mainly affect the eye.

Some side effects could be serious
Contact your doctor immediately if you experience any of the following side effects, which may be signs of an allergic reaction, inflammation, or infection:

• eye pain, increased discomfort, increased redness of the eye, blurred or reduced vision, an increase in the number of small floating particles in your field of vision, or increased sensitivity to light – these may indicate a possible eye infection or inflammation, or an allergic reaction;
• sudden reduction or change in vision.

Other possible side effects
Other side effects that may occur after treatment with Vabysmo include those listed below.
Most of these side effects are mild to moderate in intensity and usually resolve within one week after each injection.
Contact your doctor if any of the following side effects worsen.

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

• None

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

• clouding of the lens in the eye (cataract)
• tear in one of the layers located at the back of the eye (retinal pigment epithelial tear – only in nAMD)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• increased pressure inside the eye (increased intraocular pressure)
• bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage)
• moving spots or dark shapes in the field of vision (floaters in the vitreous)
• eye pain

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

• severe inflammation or infection inside the eye (endophthalmitis)
• inflammation of the gel-like substance inside the eye/red eye (vitritis)
• inflammation of the iris and adjacent tissue in the eye (iritis, iridocyclitis, uveitis)
• bleeding inside the eye (vitreous haemorrhage)
• eye discomfort
• itching (ocular pruritus)
• tear in the retina (the light-sensitive back part of the eye)
• red eye (ocular/conjunctival hyperaemia)
• sensation of a foreign body in the eye
• blurred vision
• reduced visual acuity (reduced visual acuity)
• pain during the procedure (procedural pain)
• retinal detachment
• increased tear production (increased lacrimation)
• scratch on the cornea, damage to the transparent layer covering the iris (corneal abrasion)
• eye irritation

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

• temporary reduction in visual acuity (transiently reduced visual acuity)
• clouding of the lens due to injury (traumatic cataract)

Not known

• retinal vasculitis (inflammation of blood vessels in the back of the eye)
• occlusive retinal vasculitis (blockage of blood vessels in the back of the eye, typically occurring with inflammation)

When medicines that work similarly to Vabysmo are administered, there is a known risk that blood clots may block blood vessels (arterial thromboembolic events), which could lead to heart attack or stroke. Since small amounts of the medicine may enter the bloodstream, there is a theoretical risk of such events occurring after an intravitreal injection of Vabysmo.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vabysmo

The doctor, pharmacist, or nurse is responsible for the storage of this medicinal product and
the proper disposal of unused product. The following information is intended for healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after Scad/EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Before use, the unopened vial may be stored at room temperature, between 20 °C and 25 °C, for up to 24 hours.

6. Package Contents and Other Information

What Vabysmo Contains

• The active substance is faricimab. 1 mL of injectable solution contains 120 mg of faricimab. Each vial contains 28.8 mg of faricimab in 0.24 mL of solution. This provides sufficient quantity for administration of a single dose of 0.05 mL solution containing 6 mg of faricimab.
• The other components are: L-histidine, acetic acid 30% (E 260), L-methionine, sodium chloride, sucrose, polysorbate 20 (E 432), water for injectable preparations (see section 2, “Vabysmo contains sodium and polysorbate”).

Description of the Appearance of Vabysmo and Contents of the Package
Vabysmo is a solution ranging from clear to opalescent, colourless to yellowish-brown.
Packaged in a single glass vial and one Blunt Filter sterile transfer needle (18 gauge x
1.5 inches, 1.2 mm x 40 mm, 5 µm), for single use only.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (See/siehe Belgique/Belgien)
Тел: +359 2 474 5444

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88.

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0)1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: + 385 1 47 22 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Κύπρος Sverige
Roche (Hellas) A.E. Roche AB
Τηλ: +30 210 61 66 100 Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
<-------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:

Instructions for Use of the Vial:

Before Starting:

Read all instructions carefully before using Vabysmo.
The Vabysmo kit includes a glass vial and a transfer filter needle.
The glass vial is for single use only. The filter needle is for single use only.
Vabysmo must be stored in the refrigerator at temperatures between 2 °C and

8 °C.
Do not freeze.
Do not shake.
Before administration, allow Vabysmo to reach room temperature (20 °C–25 °C). Keep the vial in its original packaging to protect the medicine from light.
The Vabysmo vial may be stored at room temperature for up to 24 hours.

Before administration, the Vabysmo vial should be visually inspected. Vabysmo is a liquid solution ranging from clear to opalescent, and from colourless to yellowish-brown.
Do not use if the medicine contains particles, appears cloudy, or shows changes in colour.
Do not use if the packaging, vial, or transfer filter needle is expired, damaged, or tampered with (see Figure A).
Use aseptic techniques when preparing for intravitreal injection.

Figure A
Gathering Materials

1. Obtain the following materials:
   • one vial of Vabysmo (included);
   • one sterile 5 µm Blunt Filter transfer needle, 18 gauge x 1.5 inches (1.2 mm x 40 mm) (included);
   • one sterile 1 mL Luer Lock syringe with a graduated mark indicating the 0.05 mL dose ( not included );
   • one sterile 30 gauge x 0.5 inch injection needle ( not included ); Note: a 30 gauge injection needle is recommended to avoid higher injection forces that may occur with smaller diameter needles;
   • one alcohol-impregnated swab ( not included ).
2. After removing the vial from its packaging, place it upright on a flat surface (for about 1 minute) to ensure all liquid settles at the bottom of the vial (see Figure B). Gently tap the vial with a finger (see Figure C), as the liquid may adhere to the upper part of the vial.

3. Remove the flip-off cap from the vial (see Figure D) and disinfect the vial stopper with an alcohol-impregnated swab (see Figure E).

Transferring Medicine from Vial to Syringe

4. Firmly attach the provided 18 gauge x 1.5 inch transfer filter needle to a 1 mL Luer Lock syringe under aseptic conditions (see Figure F).

5. Using aseptic technique, insert the transfer filter needle into the center of the vial stopper (see Figure G), push it fully in, then slightly tilt the vial so that the needle tip touches the bottom of the vial (see Figure H).

6. Hold the vial slightly tilted and withdraw slowly all the liquid (see Figure I). The blunt tip of the transfer filter needle must remain submerged in the liquid to prevent air from entering.

Attaching the Injection Needle

7. When emptying the vial, ensure the plunger is sufficiently retracted to completely empty the transfer filter needle (see Figure I).
8. Remove the transfer filter needle from the syringe and dispose of it according to local regulations. Do not use the transfer filter needle for intravitreal injection.
9. Maintaining aseptic conditions, firmly attach a 30 gauge x 0.5 inch injection needle to the Luer Lock syringe (see Figure J).

Removing Air Bubbles and Adjusting Medication Dose

10. Carefully remove the plastic protective cap from the needle by pulling firmly.
11. Hold the syringe with the needle pointing upward to check for air bubbles. If air bubbles are present, gently tap the syringe with a finger until the bubbles rise to the top (see Figure K).

12. Carefully expel air from the syringe and needle, and slowly depress the plunger so that the rubber plunger tip aligns with the graduated mark indicating the 0.05 mL dose. The syringe is now ready for injection (see Figure L). Ensure the injection is administered immediately after dose preparation.

13. Inject slowly until the rubber stopper reaches the end of the syringe to deliver the 0.05 mL volume. Confirm full dose administration by verifying that the rubber stopper has reached the end of the syringe barrel. Excess volume must be expelled before injection. To avoid overdose, the injection dose must correspond exactly to the graduated mark indicating 0.05 mL. Unused medicine and waste material must be disposed of in accordance with local regulations.