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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB 00031/0927.
Vabysmo 120 mg/mL solution for injection
Vabysmo 120 mg/mL solution for injection
faricimab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Vabysmo is and what it is used for
2. What you need to know before you use Vabysmo
3. How to use Vabysmo
4. Possible side effects
5. How to store Vabysmo
6. Contents of the pack and other information
Vabysmo contains the active substance faricimab, which belongs to a group of medicines called antineovascularisation agents. Vabysmo is injected into the eye by your healthcare professional to treat eye disorders called
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.
Vabysmo specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. In conditions like nAMD and DMO, 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.
If any of these apply to you, tell your doctor. You should not be given Vabysmo.
Talk to your doctor before receiving Vabysmo:
Furthermore it is important for you to know that:
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 use of Vabysmo in children and adolescents has not been studied because nAMD and DMO occur mainly in adults.
Tell your doctor if you are using, have recently used or might use any other medicines.
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.
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.
The medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
The recommended dose is 6 mg of faricimab.
The frequency of injections will be determined by your doctor.
nAMD
DMO
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.
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, schedule a new appointment with your doctor as soon as possible.
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.
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.
Contact your doctor immediately if you have any of the following, which are signs of allergic reactions, inflammation or infections:
Please tell your doctor immediately if you develop any of these 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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
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.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2022
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