VABYSMO 120 mg/mL Injectable Solution

2. What you need to know before you use Vabysmo

Do not use Vabysmo:

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

If you are in any of these situations, inform your doctor. You should not be given Vabysmo.

Warnings and precautions

Consult your doctor before starting treatment with Vabysmo:

• if you have glaucoma (an eye disease usually caused by high pressure in the eye).
• if you have a history of seeing flashes, lights, or floating particles (floaters) 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 surgery is planned for the next 4 weeks.
• if you have had any other eye disease or eye treatment.

Consult your doctor immediately if:

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

In addition, it is important that you know 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 side 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 if you have other risk factors that may increase the likelihood of a tear or detachment of one of the layers of the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment), in which case Vabysmo will be administered with caution.

When some medicines that work in a similar way to Vabysmo are administered, it is known that there is a 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 medicine enters the bloodstream, there is a theoretical risk of these episodes after injection of Vabysmo into the eye.

Experience is limited in the treatment of:

• patients with active infections.
• patients with nAMD and patients with retinal vein occlusion (RVO) aged 85 and older.
• patients with DME due to type 1 diabetes.
• diabetic patients with high average blood sugar levels (HbA1c above 10%).
• diabetic patients with eye disease caused by diabetes, known as proliferative diabetic retinopathy.
• diabetic patients with high blood pressure above 140/90 mmHg and vascular disease.
• patients with DME who receive injections at intervals of less than 8 weeks over a long period.

Experience is limited in the treatment of patients who receive injections at intervals of less than 8 weeks over a long period, and these patients may have a higher risk of side effects.

There is no experience in the treatment of:

• 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 treating you with Vabysmo.

Children and adolescents

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

Other medicines and Vabysmo

Tell your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy and breast-feeding

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

It is not recommended to breast-feed during treatment with Vabysmo because it is not known whether Vabysmo is excreted in human milk.

Women who could become pregnant should use effective contraception during treatment and for at least 3 months after the end of treatment with Vabysmo. If you become pregnant or think you may be pregnant during treatment, tell your doctor immediately.

Driving and using machines

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

Vabysmo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is 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 be given an injection every month for the first 3 months.
• After that, you will receive injections every 4 months. 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 given an injection every month for at least 3 months.
• After that, 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 an experienced doctor in administering eye injections.

Before the injection, your doctor will use an eye 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 pain from the injection.

How long the treatment with Vabysmo will last

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 having the desired effect. Depending on how you respond to treatment with Vabysmo, your doctor may change the frequency of doses to more or less often.

If you miss a dose of Vabysmo

If you miss a dose, make 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 may worsen.

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

4. Possible side effects

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

Side effects with Vabysmo injections are both due to the medicine and the injection procedure and may mainly affect the eye.

Some side effects may be serious

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

• eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, increased number of small particles in your vision, increased sensitivity to light – these are signs of a 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 go away within a week after each injection.

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

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 of a layer in 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 the small blood vessels on the surface 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 surrounding tissue in the eye (iritis, iridocyclitis, uveitis)
• Bleeding inside the eye (vitreous haemorrhage)
• Eye discomfort
• Itching (ocular pruritus)
• Tear of the retina (back of the eye that detects light)
• Eye redness (ocular hyperaemia/conjunctival)
• Sensation of having something in the eye
• Blurred vision
• Decreased sharpness of vision (reduced visual acuity)
• Pain during the procedure
• Retinal detachment
• Increased production of tears (increased lacrimation)
• Scratch on the cornea, damage to the transparent layer 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 in the back of the eye)
• Occlusive retinal vasculitis (blockage of the blood vessels in the back of the eye, usually in the presence of inflammation)

When some medicines that work in a similar way to Vabysmo are administered, it is known that there is a 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 medicine enters the bloodstream, there is a theoretical risk of these episodes after injection of Vabysmo into the eye.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if you think they might be unrelated to the medicine. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side 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 disposing of any unused product correctly. 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 which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Store in the outer carton to protect from light.

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

6. Container Contents and Additional Information

Vabysmo Composition

• The active ingredient is faricimab. One ml 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, 30% acetic acid (E 260), L-methionine, sodium chloride, sucrose, polysorbate 20 (E 432), water for injectable preparations (see Section 2 "Vabysmo contains sodium and polysorbate").

Product Appearance and Container Contents

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

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

Marketing Authorization Holder and Manufacturer

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:

Date of Last Revision of this Leaflet:

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

This information is intended for healthcare professionals only:

Instructions for Use of the Vial:

Gather the Components: