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

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

faricimab

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will provide you with a patient guide containing important safety information to help you understand the benefits and risks associated with Vabysmo, and the actions you should take if you experience certain symptoms.

Contents of this leaflet

1. What Vabysmo is and what it is used for
2. What you need to know before using 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 antineovascularization agents.

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

• neovascular (exudative) age-related macular degeneration (nAMD),
• vision impairment due to diabetic macular edema (DME),
• vision impairment due to macular edema caused by blockage of the retinal veins (retinal vein branch 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) which is responsible for sharp, central vision. nAMD occurs due to the growth of abnormal blood vessels that leak blood and fluid into the macula. DME is caused by leaky blood vessels leading to swelling of the macula. CRVO is the blockage of the main blood vessel (vein) that carries blood away from the retina, while BRVO is the blockage of one of the smaller branches of this main vein. Due to increased pressure within the veins, fluid leaks into the retina, causing swelling of the macula (macular edema).

How Vabysmo works

Vabysmo specifically recognizes and blocks the activity of certain proteins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present at higher than normal levels, they may cause the growth of abnormal blood vessels and/or damage to normal vessels, resulting in leakage into the macula, leading to 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 may improve the disease and/or slow its progression, thereby helping to maintain, or even improve, your vision.

2. What you need to know before using Vabysmo

Do not use Vabysmo:

• if you are allergic to faricimab or to any of the other components of this medicine (listed in section 6).
• if you have an active infection or suspect an infection in or around the eye.
• if you have 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 starting to use Vabysmo:

• if you have glaucoma (an eye disease usually caused by high pressure in the eye).
• if you have a history of seeing flashes of light, floaters, or black spots (floaters), or if you experience 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 ever had any eye disease or eye treatment.

Contact your doctor immediately if:

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

In addition, it is important to know that:

• the safety and efficacy of Vabysmo when administered in both eyes simultaneously has not been studied, and using it 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 injection. Your doctor will monitor this after each injection.
• your doctor will check whether you have other risk factors that may increase the likelihood of a tear or detachment of one of the layers at the back of the eye (retinal tear or detachment, or retinal pigment epithelial tear or detachment), in which case Vabysmo will be administered with caution.

When certain medicines that work similarly to Vabysmo are administered, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. Since a small amount of the medicine enters the bloodstream, there is a theoretical risk of such events following injection of Vabysmo into the eye.

Experience is limited in treating:

• patients with active infections.
• patients with nAMD and patients with retinal vein occlusion (RVO) aged 85 years and older.
• patients with DME due to type I diabetes.
• diabetic patients with high average blood sugar levels (glycated hemoglobin above 10%).
• diabetic patients with diabetes-related eye disease known as proliferative diabetic retinopathy.
• diabetic patients with high blood pressure above 140/90 mmHg and blood vessel disease.
• patients with DME receiving injections at intervals shorter than 8 weeks over a long period of time.

Experience is limited in treating patients receiving injections at intervals shorter than 8 weeks over a long period of time, and these patients may have an increased risk of adverse effects.

There is no experience in treating:

• diabetic patients or patients with RVO with uncontrolled high blood pressure.

If any of the above applies to you, your doctor will take this lack of information into account when deciding on your treatment with Vabysmo.

Children and adolescents

The use of Vabysmo has not been studied in children and adolescents, as nAMD, DME, and RVO occur primarily in adults.

Other medicines and Vabysmo

Tell your doctor if you are taking, have recently taken, or might need to 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 unborn child.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

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

Women who could become pregnant should use an effective method of contraception during treatment and for at least three months after completing treatment with Vabysmo. If you become pregnant or think you are pregnant 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 while these symptoms persist.

Vabysmo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

Vabysmo contains polysorbate

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

3. How to use Vabysmo

How Vabysmo is administered

The recommended dose is 6 mg of faricimab.

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

• You will receive an injection every month for the first 3 months.
• Afterwards, you may receive injections up to every 4 months. Your doctor will determine the frequency of injections based on the condition of your eye.

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

• You will receive an injection every month for at least 3 months.
• Afterwards, you may receive injections less frequently. Your doctor will determine the frequency of injections based on the condition of your eye.

Method of administration

Vabysmo is injected into the eye (intravitreal injection) by a physician experienced 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 anaesthetic) to numb the eye and reduce or prevent injection pain.

How long Vabysmo treatment lasts

This is a long-term treatment, which may continue for months or years. Your doctor will monitor your condition regularly to ensure the treatment is having the desired effect. Depending on your response to Vabysmo treatment, your doctor may adjust the dosing frequency accordingly.

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 interrupt treatment with Vabysmo

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects of Vabysmo injections are due to both the medicine and the injection procedure itself, and mostly affect the eye.

Some adverse effects may be serious

Contact your doctor immediately if you experience any of the following symptoms, which are signs of allergic reactions, inflammation, or infections:

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

Other possible adverse effects

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

Many of these adverse effects are mild or moderate and usually resolve within one week after each injection.

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

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

• None

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

• Clouding of the lens in the eye (cataract)
• Tear in one of the layers 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 shadows in your vision (vitreous floaters)
• 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/eye redness (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 (the light-sensitive layer at the back of the eye)
• Red eye (ocular/conjunctival hyperaemia)
• Sensation of having something in the eye
• Blurred vision
• Decreased sharpness of vision (reduced visual acuity)
• Pain during the procedure
• Retinal detachment
• Increased tear production (increased lacrimation)
• Corneal scratch, damage to the transparent part of the eyeball covering the iris (corneal abrasion)
• Eye irritation

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

• Temporary decrease in sharpness of vision (transiently reduced visual acuity)
• Clouding of the lens due to injury (traumatic cataract)

Frequency not known

• Retinal vasculitis (inflammation of the blood vessels at the back of the eye)
• Occlusive retinal vasculitis (blockage of the blood vessels at the back of the eye, usually in the presence of inflammation)

When certain medicines similar to Vabysmo are administered, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. Since a small amount of the medicine enters the bloodstream, there is a theoretical risk of such events following injection of Vabysmo into the eye.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vabysmo

Your doctor, pharmacist, or nurse is responsible for storing this medicine and properly disposing of any 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 label and packaging after EXP. The expiry date refers to the last day of the month indicated.

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 up to 24 hours.

6. Contents of the pack and other information

Composition of Vabysmo

• The active substance is faricimab. One 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 usable dose to deliver a single dose of 0.05 ml of 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 polysorbate”).

Appearance of the product and contents of the pack

Vabysmo 120 mg/ml solution for injection (injection) in a pre-filled syringe is a clear to opalescent, transparent to yellowish-brown solution.

The pack contains a filter needle with an extra-thin wall (30 gauge x ½ inch, 0.30 mm x 12.7 mm, 5 µm), together with a single-use pre-filled syringe.

Marketing Authorization Holder and Manufacturing Responsible

Roche Registration GmbH

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Instructions for use of the pre-filled syringe: