InfoCons Consumer Protection informs you – Vabysmo – Package Leaflet

Before anything else

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

In addition to the leaflet, you r doctor will give you a patient guide which provides important safety information to assist in your understanding of benefits and ris ks associated with Vabysmo, and action to take should you experience certain symptoms.

ℹ️ 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 antineovascularisation agents.

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

• neovascular (wet) age-related macular degeneration (nAMD),
• visual impairment due to d iabetic macular oedema (DME),
• visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

These disorders affect the macula, the central part of the reti na (the light-sensitive layer at the back of the eye) that is respo nsible for fine, centr al vision. nAMD is caused by the growth of abnormal blood vessels which leak blood and flu id into the macula, and DME is caused by leaky blood vessels that cause swelling of the macula. Cen tral RVO is the blockage of th e main blood ves sel (vein) that transports blood away from the retina, and branch RVO is the bl ockage of one of the smaller branches of the main blood vein. Due to the increased pressure within th ese blood vessels, there is leakage of fluid into the retina, causing swelling of the macula (macular edema).

How Vabysmo works

Vabysmo specifically recognises and blocks the activity of prot eins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are p resent at higher levels than normal, they can cause growth of abnormal blood vessels and/or damage t o normal vessels, with leakage into the macula, caus ing swelling or damage th at can negatively affe ct a person’s vision. By attaching to these proteins, Vabysmo can block their actions and prevent abn ormal vessel growth, leakage and swelling. Vabysmo may i mprove the disease and/or slow down wors ening of the disease and thereby maintain, or even improve, your vision.

⚠️ 2. What you need to know before you receive Vabysmo

You should not receive Vabysmo:

• if you are allergic t o faricimab or any of the other ingredie nts of this medicine (listed in section 6).
• if you have an active or suspected infection in or around the eye.
• if you have pain or redness in your eye (eye inflammation).

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

Warnings and precautions

Talk to your doctor before receiving Vabysmo:

• if you have glaucoma (an eye condition usually caused by high pressure in the eye).
• if you 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.
• if you have had eye surgery in the last 4 weeks or if eye sur gery is planned in the next 4 weeks.
• if you have ever had any eye diseases or eye treatments.

Tell your doctor immediately if you:

• develop sudden vision loss.
• develop signs of a possible eye infection or inflammation, su ch as increased redness of the eye, eye pain, increased eye discomfort, blurred or decreased vision , an increased number of small particles in your vision, inc reased sensitivity to light.

Furthermore it is important for you to know that:

• the safety and efficacy of Vabysmo when administered to both eyes at the same time has not been studied and use in this way may lead to an increased risk of side effects.
• injections with Vabys mo may cause a temporary increase in eye pressure (intrao cular pressure) in some patients within 60 minute s of the injection. Your docto r will monitor th is after each injection.
• your doctor will chec k whether you have o ther risk factors th at 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 epithe lial detachment or tear), in which case V abysmo must be given with caution.

When some medicines that work in a similar way to Vabysmo are g iven, there is known to be a risk of blood clots blocking blood vessels (arterial thromboembolic eve nts), which may lead to heart attack or stroke. As small amounts of the m edicine enter th e blood, there is a theoretical ris k of such events following injection of Vabysmo into the eye.

There is only limited experien ce in the treatment of:

• patients with active infections.
• patients with nAMD and RVO 85 years or older. • patients with DME due to type I diabetes. • diabetics with high average blood sugar values (Hb1Ac over 10 %).
• diabetics with an eye disease caused by diabetes called proli ferative diabetic retinopathy.
• diabetics with high blood pressure greater than 140/90 mmHg a nd disease of the blood vessels.
• patients with DME receiving injections less than every 8 week s over a long period of time.

There is only limited experience i n the treatment of patients r eceiving injections less than every 8 weeks over a long period of time, and these patients may be a t greater risk of side effects.

There is no experience in the treatment of:

• diabetics or RVO patients with uncontrolled high blood pressu re.

If any of the above a pplies to you, your do ctor will consider t his lack of informatio n when treating you with Vabysmo.

Children and adolescents

The use of Vabysmo in children and adolescents has not been stu died because nAMD, DME, and RVO occur mainly in adults. Other medicines and Vabysmo Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and b reast-feeding Vabysmo has not been studied in pregnant women. Vabysmo should not be used during pregnancy unless the potential be nefit to the patient outweighs the poten tial risk to the unborn child.

If you are pregnant or breast-feeding, think you may be pregnan t or are planning to have a baby, ask your doctor for advice before this medicine is given to you.

Breast-feeding is not recommende d during treatment with Vabysmo because it is not known whether Vabysmo passes into human milk.

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 Vab ysmo. If you become pregnant or think you are pregnant during treatme nt, tell your doctor right away.

Driving and using machines

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

Vabysmo contains sodium

The medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium- free”.

Vabysmo contains polysorbate

This medicine contains 0.02 mg of polysorbate in each 0.05 mL d ose. Polysorbates may cause allergic reactions. Tell your doctor that you have any known allergies.

💊 3. How to use Vabysmo

How Vabysmo is given The recommended dose is 6 mg of faricimab.

Neovascular (wet) age-related macular degeneration (nAMD)

• You will be treated with one injection ev ery month for the fi rst 3 months.
• After that, you may receive injections up to every 4 months. Your doctor will decide on the frequency of the injections based on th e condition of your eye.

Visual impairment due to diabetic macular oedema (DME) and macu lar oedema second ary to retinal vein occlusion (branch RVO or central RVO)

• You will be treated with one injection ev ery month for a mini mum of 3 months.
• After that, you may receive injections less frequently. Your doctor will decide o n the frequency of the injections based on the condition of your eye.

Method of administration Vabysmo is injected in to your eye (intravitr eal injection) by a doctor experienced in giving eye injections. Before the injection yo ur doctor will use a disinfectant eyewas h to clean your eye carefully to prevent infection. Your doctor will give you an eye drop (local anaesth etic) to numb the eye to reduce or prevent pain from the injection.

How long does Vabysmo treatment last for This is a long-term treatment, p ossibly continuing for months o r years. Your doctor will regularly monitor your condition to check that the tr eatment is working. Depending on how you respond to the treatment with Vabysmo, your doctor may ask you to change to a more or less frequent dose.

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 using Vabysmo

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

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, altho ugh not everybody gets them.

The side effects with Vabysmo injection are either from the med icine itself or fro m the injection procedure and they mostly affect the eye.

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

• eye pain, increased discomfort, increased eye redness, blurre d or decreased vision, a higher number of small particles in your vision, or increased sensitiv ity to light – these are signs of a possible eye infection, inflamm ation, or allerg ic reaction.
• a sudden decrease or change in vision. Other possible side effects Other side effects which may occu r after Vabysmo treatment incl ude those lis ted below.

Most of the side effects are m ild to moderate a nd will generall y 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 10 people)

• None

Common (may affect up to 1 in 10 people )

• Cloudy lens in the eye (cataract)
• Tear of one of the layers in the back of the eye (retinal pig ment epithelial t ear – nAMD only)
• Detachment of the ge l-like substance insi de the eye (vitreous detachment)
• Increase in pressure inside the eye (increased intraocular pr essure)
• Bleeding from small blood vesse ls in the outer layer of the e ye (conjunctival haemorrhage)
• Moving spots or dark shapes in your vision (vitreous floaters )
• Eye pain

Uncommon (may affect up to 1 in 100 people)

• Serious inflammation or infection inside the eye (endophthalm itis)
• Inflammation of the gel-like su bstance inside the eye/red eye (vitritis)
• Inflammation in the iris and its adjacent tissue in the eye ( iritis, iridocyclitis, uveitis)
• Bleeding inside the eye (vitreous haemorrhage)
• Eye discomfort
• Itching (eye pruritus) • Tearing of the retina (the back of the eye that detects light )
• Red eye (ocular/conjunctival hyperaemia)
• A feeling of having something in the eye
• Blurred vision
• Decreased sharpness of vis ion (visual acuity reduced)
• Pain during the procedure (procedural pain)
• Detachment of the retina
• Increased tear production (increased lacrimation)
• Scratched cornea, damage to the clear layer of the eyeball th at covers the iris ( corneal abrasion)
• Eye irritation

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

• Temporary decreased sharpness of vision (visual acuity reduce d transiently)
• Clouding of the lens due t o injury (traumatic cataract)

Not known

• Retinal vasculitis (inflammatio n of blood vessels in the back of the eye)
• Retinal occlusive vasculitis (bl ockage of blood vessels in th e back of the eye, typically in presence of inflammation) When some medicines that work in a similar way to Vabysmo are g iven, there is known to be a risk of blood clots blocking blood vessels (arterial thromboembolic eve nts), which may lead to heart attack or stroke. As small amounts of the medicine enter the blood, there is a theoretical ris k of such events following injection of Vabysmo into the eye.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible sid e effects not listed in this leaflet. You can also report side effects directly via the national repo rting system listed in Appendix V . By reporting side effects you can help provide more informati on on the safe ty of this medicine.

🌡️ 5. How to store Vabysmo

Your doctor, pharmacist or nurse is responsible for storing thi s medicine and disposing of any unused product correctly. The following information is intended for he althcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after t he expiry date which is stated on the carton and la bel after 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 carto n in order to protect from ligh t.

Prior to use, the unopened vial may be kept at room temperature , 20 °C to 25 °C, for up to 24 hours.

📦 6. Contents of the pack and other information

What Vabysmo contains

• The active substance is faricim ab. One mL solution for inject ion contains 120 mg faricimab.

Each 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 fa ricimab.

• The other ingredients are: L-histidine, acetic acid 30% (E 26 0), L-methionine, sodium chloride,

sucrose, polysorbate 20 (E 432), water for injections (see Sect ion 2 “Vabysmo contains sodium and polysorbate”).

What Vabysmo looks like and contents of the pack

Vabysmo is a clear to opalescent , colourless to brownish-yellow solution.

Pack size of one glass vial and o ne sterile blunt transfer filt er needle (18-gauge x 1½ inch, 1.2 mm x 40 mm, 5 µm) for single-use only.

Marketing Authorisation 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 any information about this m edicine, please contact the loc al representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Luxembourg/Luxemburg N.V. Roche S.A.

België/Belgique/Belgien Tél/Tel: +32 (0) 2 525 82 11 Latvija Roche Latvija SIA Tel: +371 – 6 7039831 България Рош България ЕООД Тел: +359 2 474 5444 Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799 Česká republika Roche s. r. o.

Tel: +420 – 2 20382111 Magyarország Roche (Magyarország) Kft.

Tel: +36 – 1 279 4500 Danmark Roche Pharmaceuticals A/S Tlf: +45 – 36 39 99 99 Nederland Roche Nederland B.V.

Tel: +31 (0) 348 438050 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140 Norge Roche Norge AS Tlf: +47 – 22 78 90 00 Eesti Roche Eesti OÜ Tel: + 372 – 6 177 380 Österreich Roche Austria GmbH Tel: +43 (0) 1 27739 Ελλάδα, Κύπρος Roche (Hellas) A.E.

Ελλάδα Τηλ: +30 210 61 66 100 Polska Roche Polska Sp.z o.o.

Tel: +48 – 22 345 18 88.

España Roche Farma S.A.

Tel: +34 – 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel: +351 – 21 425 70 00 France Roche Tél: +33 (0)1 47 61 40 00 România Roche România S.R.L. Tel: +40 21 206 47 01 Hrvatska Roche d.o.o.

Tel: + 385 1 47 22 333 Slovenija Roche farmacevtska družba d.o.o.

Tel: +386 – 1 360 26 00 Ireland/Malta Roche Products (Ireland) Ltd.

Ireland/L-Irlanda Tel: +353 (0) 1 469 0700 Slovenská republika Roche Slovensko, s.r.o.

Tel: +421 – 2 52638201 Ísland Roche Pharmaceuticals A/S c/o Icepharma hf Sími: +354 540 8000 Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500 Italia Roche S.p.A.

Tel: +39 – 039 2471 Sverige Roche AB Tel: +46 (0) 8 726 1200

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the Europ ean Medicines Agency web site: https://www.ema.europa.eu/en . <————————————————————– ————————————————> The following informa tion is intended for healthcare profession als only:

Instructions for use of vial:

Before you start:

Read all the instructions caref ully before using Vabysmo.

The Vabysmo kit includes a glass vial and transf er filter needl e. The glass vial is for a single dose only. The filter n eedle is for single use only.

Vabysmo should be stored refrigerated at temperatures between 2 °C to 8 °C.

Do not freeze.

Do not shake.

Allow Vabysmo to reach room temperature, 20 °C to 25 °C before proceeding with the administration. Keep the vial in the ori ginal carton to protect from light.

The Vabysmo vial may be kept at room temperature for up to 24 hours.

The Vabysmo vial should be inspected visually prior to administ ration. Vabysmo is a clear to opalescent an d colorless to brownish- yellow liquid solution.

Do not use if particulates, cloudiness, or discoloration are visible.

Do not use if the packaging, vial and/or transfer filter needle are ex pired, damaged, or have been tampered with (see Figure A ).

Use aseptic technique to carry out the preparation of the intra vitreal injection.

Figure A Gather supplies 1 Gather the following supplies:

• One Vabysmo vial (included)
• One sterile 5-micron blunt transfer filter needle 18-gauge x 1½ inch, 1.2 mm x 40 mm (included)
• One sterile 1 mL Luer lock syringe with a 0.05 mL dose mark ( not included )
• One sterile injection need le 30-gauge x ½ inch ( not included ) Note that a 30-gauge injec tion needle is recommended to avoid incre ased injection forces that could be experienc ed with smaller di ameter needles.
• Alcohol swab ( not included ).

2 To ensure all liquid settles at the bottom of the vial, place t he vial upright on a flat surface (for about 1 minute) after removal from packaging (see Figure B ). Gently tap the vial with your finger (see Figure C ), as liquid may stick to the top of the vial.

Figure B Figure C 3 Remove the flip-off cap from the vial (see Figure D ) and wipe the via l septum with an alcohol swab (see Figure E ).

Figure D Figure E Transfer medicinal produc t from vial to syringe 4 Aseptically and firmly attach the included 18-gauge x 1½ inch t ransfer filter needle onto a 1 mL Luer lock syringe (see Figure F ).

Figure F 5 Using aseptic techniqu e, push the tr ansfer filter needle into t he center of the vial septum (see Figure G ), push it all the way in, then tilt the vial slightly so that the needle touches the bottom edge of the vial (see Figure H ).

Figure G Figure H 6 Hold the vial slig htly inclined and slowly withdraw all the liquid from the vial (see Figure I ). Keep the bevel of the transfer filter ne edle submerged in th e liquid, to avoid introduction of air.

Figure I Attach injection needle 7 Ensure that the plunger rod is dr awn sufficiently back when emp tying the vial, in order to completely empty the tra nsfer filter needle (see Figure I ).

8 Disconnect the transfer filter needle from the syringe and disp ose of it in accordance with local regulations.

Do not use the transfer filter needle for the intravitreal inje ction.

9 Aseptically and firmly attach a 3 0-gauge x ½ inch injection nee dle onto the Luer lock syringe (see Figure J ).

Figure J Dislodge air bubbles and adju st medicinal product dose 10 Carefully remove the plastic needl e shield from the needle by p ulling it straight off.

11 To check for air bubbles, hold the syringe with the needle poin ting up. If there are any air bubbles, gently tap the syringe w ith your finger until the bubb les rise to the top (see Figure K ).

Figure K 12 Carefully expel the air from the syringe and needle, and slowly depress the plunger to align the rubber stopper tip to the 0.05 mL dose mark. The syri nge is ready for the injection (see Figure L ). Ensure that the i njection is given immediately after preparation of the dose.

Figure L 13 Inject slowly until the rubber sto pper reaches the end of the s yringe to deliver the volume of 0.05 mL. Confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel.

Excess volume should be expelled prior to injection. The inject ion dose must be set to the 0.05 mL dose mark to avoid overdose.

Any waste material or unused med icinal product should be dispos ed of in accordance with local regulations.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Vabysmo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1683).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.