Patient leaflet - Vabysmo 120 mg/ml solution for injection
1. What Vabysmo is and what it is used for
Vabysmo contains the active substance faricimab, which belongs to a group of medicines called anti-neovascularisation agents. Vabysmo is injected into the eye by your healthcare professional to treat eye disorders called
- neovascular (wet) age-related macular degeneration (nAMD),
- visual impairment due to diabetic macular oedema (DMO),
visual impairment due to macular oedema secondary to retinal vein
occlusion (branch RVO (BRVO) or central RVO (CRVO).
What Vabysmo is used for
Vabysmo is used in adults to treat nAMD and DMO, which both affect the macula, the central part of the retina (the light-sensitive layer at the back of the eye) that is responsible for fine, central vision. nAMD is caused by the growth of abnormal blood vessels which leak blood and fluid into the macula, and DMO is caused by leaky blood vessels that cause swelling of the macula.
Central RVO is the blockage of the main blood vessel (vein) that transports blood away from the retina, and branch RVO is the blockage of one of the smaller branches of the main blood vessel. Due to the increased pressure within these blood vessels, there is leakage of fluid into the retina, causing swelling of the macula (macular oedema).
How Vabysmo works
Vabysmo specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. In conditions like nAMD, DMO and RVO, these proteins can be present in higher levels than normal, and this can cause the growth of abnormal blood vessels and/or damage to the normal vessels. These changes to the blood vessels can result in leakage into the retina, causing swelling of the retina or damage to the layers of the retina, which can negatively affect a person’s vision. By attaching to these proteins, Vabysmo can block their actions and prevent abnormal vessel growth, leakage and swelling. Vabysmo may improve disease and/or slow down worsening of the disease and thereby maintain, or even improve, your vision.
2. What you need to know before you use Vabysmo
Do not use Vabysmo:
- 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 you are allergic to faricimab or any of the other ingredients of this
medicine (listed in section 6).
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 four weeks or if eye surgery
is planned in the next four 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, such as
worsening redness of the eye, eye pain, increased eye discomfort, blurred or decreased vision, an increased number of small particles in your vision, increased sensitivity to light.
Furthermore it is important for you to know that:
limited data are available on the safety and efficacy of Vabysmo
therapy when administered to both eyes at the same time. Until further data are available, it is possible that use in this way may lead to an increased risk of experiencing side effects.
injections with Vabysmo may cause a temporary increase in eye
pressure (intraocular pressure) in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
your doctor will check whether you have other risk factors that 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 epithelial detachment or tear), in which case Vabysmo must be given with caution.
Injecting vascular endothelial growth factor inhibitors, substances similar to those contained in Vabysmo, directly into the bloodstream is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. There is a theoretical risk of such events following injection of Vabysmo into the eye. The limited safety data from use in both eyes at the same time does not suggest an increased risk of systemic events.
Children and adolescents
The use of Vabysmo in children and adolescents has not been studied because nAMD, DMO 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 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 this medicine is given to you.
Breast-feeding is not recommended 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 Vabysmo. If you become pregnant or think you are pregnant during treatment, tell your doctor right away. Ask your doctor for advice before starting Vabysmo treatment.
Driving and using machines
After your injection with Vabysmo, you may have temporary vision 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”.
3. How to use Vabysmo
How much and how often Vabysmo is given
The recommended dose is 6 mg of faricimab.
The frequency of injections will be determined by your doctor.
nAMD, DMO and RVO
Patients who are new to intravitreal treatments:
You will be treated with one injection every month for at least
3 months
After that, you may receive injections less frequently. Your doctor will
decide on the frequency of the injections based on the condition of your eye.
Patients switching to Vabysmo:
Your doctor will decide on the frequency of the injections based on
the condition of your eye and its response to your previous treatment.
Method of administration
Vabysmo is injected into your eye (intravitreal injection) by a healthcare professional experienced in giving eye injections.
Before the injection your healthcare professional will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your healthcare professional will give you an eye drop (local anaesthetic) 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, 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 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 treatment may increase your 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, although not everybody gets them.
The side effects with Vabysmo injection are either from the medicine itself or from 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, inflammation or infections:
eye pain, increased discomfort, worsening eye redness, blurred or
decreased vision, a higher number of small particles or floaters in your vision, or increased sensitivity to light – these are signs of a possible eye infection or inflammation.
- a sudden decrease or change in vision.
Please tell your doctor immediately if you develop any of these side effects.
Other possible side effects
Other side effects which may occur after Vabysmo treatment include those listed below.
Most of the side effects are mild to moderate and will generally 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 pigment
epithelial tear - nAMD only)
Detachment of the gel-like substance inside the eye (posterior
vitreous detachment)
Increase in 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 your vision (vitreous floaters) ● Eye pain
Uncommon (may affect up to 1 in 100 people):
- Serious inflammation or infection inside the eye (endophthalmitis)
- Inflammation of the gel-like substance inside the eye (vitritis)
Inflammation in the iris and its adjacent tissue in the eye (iritis,
iridocyclitis, uveitis)
- Bleeding in 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 vision (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 that
covers the iris (corneal abrasion)
- Eye irritation
Rare (may affect up to 1 in 1,000 people):
Temporary decreased sharpness of vision (visual acuity reduced
transiently)
- Clouding of the lens due to injury (traumatic cataract)
Not known (frequency cannot be estimated from the available data):
Retinal vasculitis (inflammation of blood vessels in the back of the
eye)
Retinal occlusive vasculitis (blockage of blood vessels in the back of
the eye, typically in presence of inflammation)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vabysmo
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 carton and label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Keep the vial in the original carton in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature, 20°C to 25°C, for up to 24 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Vabysmo contains
The active substance is faricimab. One mL solution for injection
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 faricimab.
The other ingredients are: histidine, acetic acid 30% (E 260),
methionine, sodium chloride, sucrose, polysorbate 20 (E 432), water for injections.
What Vabysmo looks like and contents of the pack
Vabysmo 120 mg/mL solution for injection is a clear to opalescent, colourless to brownish-yellow solution.
Pack size of one glass vial and one sterile 5 µm blunt transfer filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm) for single use only.
Marketing Authorisation Holder and Manufacturer
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
This leaflet was last revised in July 2026
The following information is intended for healthcare professionals only:
Instructions for use of vial:
Before you start:
Read all the instructions carefully before using Vabysmo.
The Vabysmo kit includes a glass vial and transfer filter needle. The glass vial is for a single dose only. The filter needle is for single use only.
Vabysmo should be stored refrigerated at temperatures between 2ºC to 8ºC.
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 original 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 administration. Vabysmo is a clear to opalescent and 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 expired, damaged, or have been tampered with (see Figure A).
Use aseptic technique to carry out the preparation of the intravitreal 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 needle 30-gauge x ½ inch (not included) Note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles.
- Alcohol swab (not included).
2 To ensure all liquid settles at the bottom of the vial, place the 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 vial septum with an alcohol swab (see Figure E).
Figure D Figure E
Transfer medicinal product from vial to syringe
4 Aseptically and firmly attach the included 18-gauge x 1½ inch transfer filter needle onto a 1 mL Luer lock syringe (see Figure F).
Figure F
5 Using aseptic technique, push the transfer filter needle into the 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 slightly inclined and slowly withdraw all the liquid from the vial (see Figure I). Keep the bevel of the transfer filter needle submerged in the liquid, to avoid introduction of air.
Figure I
Attach injection needle
7 Ensure that the plunger rod is drawn sufficiently back when emptying the vial, in order to completely empty the transfer filter needle (see Figure I).
8 Disconnect the transfer filter needle from the syringe and dispose of it in accordance with local regulations.
Do not use the transfer filter needle for the intravitreal injection.
9 Aseptically and firmly attach a 30-gauge x ½ inch injection needle onto the Luer lock syringe (see Figure J).
Figure J
Dislodge air bubbles and adjust medicinal product dose
10 Carefully remove the plastic needle shield from the needle by pulling it straight off.
11 To check for air bubbles, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles 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 syringe is ready for the injection (see Figure L). Ensure that the injection is given immediately after preparation of the dose.
Figure L
13 Inject slowly until the rubber stopper reaches the end of the syringe 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.
Any waste material or unused medicinal product should be disposed of in accordance with local regulations.