120 mg/ml solution
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 antineovascular agents.
Vabysmo is injected into the eye by a doctor to treat adults with eye diseases:
- neovascular (wet) age-related macular degeneration (AMD),
- visual impairment caused by diabetic macular edema (DME).
These conditions affect the macula ( yellow spot ), which sits in the center of the retina (the light-sensitive area at the back of the eye) and is responsible for central visual acuity. AMD is caused by the growth of abnormal blood vessels that leak blood and fluid into the macula, and DME is caused by leaky blood vessels that cause the macula to swell.
How does Vabysmo work
Vabysmo specifically recognizes the proteins angiopoietin-2 and vascular endothelial growth factor A and blocks their activity. When these proteins are present at higher than normal levels, they can cause the growth of abnormal blood vessels and/or damage to normal blood vessels. This leads to leakage into the macula causing swelling or damage, which can negatively affect vision. By binding to these proteins, Vabysmo can block their activity and prevent abnormal growth of blood vessels as well as leakage and swelling. Vabysmo can improve the disease and/or slow down the deterioration of the disease and thereby preserve or even improve vision.
What you need to know before you are given Vabysmo
You should not be given 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 or suspected infection in or around the eye.
- if you have eye pain or if the eye is red (ophthalmitis).
If any of these apply to you, tell your doctor. You should then not be treated with Vabysmo.
Warnings and precautions
Talk to your doctor before receiving Vabysmo:
- if you have glaucoma ( glaucoma, a condition usually caused by high pressure in the eye).
- if you have previously seen flashes of light or dark dots floating in your field of vision or if the number and size of such dots have suddenly increased.
- if you have had eye surgery in the last four weeks or if eye surgery is planned within the next four weeks.
- if you have or have ever had any eye disease or received eye treatments.
Talk to your doctor immediately:
- if vision suddenly deteriorates.
- if you notice signs of a possible infection or inflammation in the eye such as increased redness in the eye, eye pain, increased discomfort in the eye, blurred or impaired vision, increased number of small dots in the field of vision, and increased sensitivity to light.
It is also important for you to know that:
- safety and efficacy of Vabysmo given simultaneously in both eyes have not been studied and if it is used in this way, it may be associated with an increased risk of suffering side effects.
- injection of Vabysmo may temporarily increase the pressure in the eye ( intraocular pressure ) in some patients within 60 minutes of injection. Your doctor will check this after each injection.
- the doctor will examine whether you have other risk factors that may increase the risk of a hole in or detachment of one of the layers in the back of the eye (retinal detachment or rupture, pigment epithelium detachment or rupture ). In such a case, Vabysmo should be given with caution.
When certain medicines that work in a similar way to Vabysmo are given, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which can lead to heart attack or stroke. Because small amounts of the drug are absorbed into the blood, there is a theoretical risk of such events following the injection of Vabysmo into the eye.
There is only limited experience in the treatment of:
patients with active infection
- patients with neovascular (wet) age-related macular degeneration (AMD) who are 85 years or older
- patients with diabetic macular edema (DME) caused by type I diabetes
- diabetics with high average blood sugar (Hb1c above 10%)
- diabetics with eye disease caused by so-called diabetic proliferative diabetic retinopathy
- diabetics with high blood pressure, higher than 140/90 mmHg, and blood vessel disease
- patients with DME who receive injections less often than every 8 weeks for a longer period
There is only limited experience in the treatment of patients who receive injections less than every 8 weeks for a longer period and these patients may be at a greater risk of side effects.
There is no experience in the treatment of:
- diabetics with uncontrolled high blood pressure.
If any of the above applies to you, your doctor will consider this lack of information when treating you with Vabysmo.
Children and young people
The use of Vabysmo in children and adolescents has not been studied because AMD and DME mainly occur in adults.
Other medicines and Vabysmo
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Vabysmo has not been studied in pregnant women. Vabysmo should not be used during pregnancy unless the expected benefit to the patient outweighs the potential risk to the fetus.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being treated with this medicine.
Breastfeeding is not recommended during treatment with Vabysmo as it is unknown whether Vabysmo passes into breast milk.
Women of childbearing potential must use an effective method of contraception during treatment and for at least three months after treatment with Vabysmo has stopped. If you become pregnant or think you are pregnant during treatment, tell your doctor immediately.
Driving ability and use of machinery
After an injection of Vabysmo, temporary vision problems may occur (eg, blurred vision). Do not drive vehicles or use machinery while these last.
Vabysmo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use Vabysmo
How Vabysmo is given
The recommended dose is 6 mg faricimab.
Wet neovascular age-related macular degeneration (wet AMD, AMD )
- During the first 4 months, you will receive one injection per month.
- After that, you can receive injections at intervals of no more than 4 months. Your doctor will decide how often the injections should be given depending on the condition of the eye.
Visual impairment caused by diabetic macular edema ( DME )
- During the first 4 months, you will receive one injection per month.
- After that, you can receive injections at intervals of no more than 4 months. Your doctor will decide how often the injections should be given depending on the condition of the eye.
Mode of administration
Vabysmo is injected into the eye (intravitreal injection ) by a doctor who is experienced in giving injections into the eye.
Before the injection, the doctor will carefully clean your eye with disinfectant eye wash to prevent infection. The doctor will give you eye drops ( local anesthetic ) to numb the eye and reduce or prevent pain during the injection.
How long does treatment with Vabysmo last?
This is a long-term treatment that can last for months or years. Your doctor will regularly check your condition to make sure the treatment is working. Depending on how you respond to treatment with Vabysmo, your doctor may ask you to come for treatment at shorter or longer intervals.
If you have missed a dose of Vabysmo
If you have missed a dose, make a new appointment with your doctor as soon as possible.
If you stop using Vabysmo
Talk to your doctor before stopping treatment. The risk of vision loss may increase and vision may deteriorate if you stop treatment.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, but not everyone who is treated will get them.
The side effects of injection with Vabysmo depend either on the drug itself or on the injection, and the side effects mainly affect the eye.
Some side effects can be serious
Contact the doctor immediately if you notice any of the following, which are signs of allergic reactions, inflammation, or infection:
- eye pain, increased discomfort, increased eye redness, blurred or impaired vision, increased number of small spots in the field of vision, or increased sensitivity to light – these are signs of a possible infection, inflammation of the eye, or an allergic reaction.
- sudden deterioration or change in vision.
Other possible side effects are
Other side effects that may occur after treatment with Vabysmo are listed below.
Most side effects are mild to moderate and generally disappear within a week after each injection.
Contact a doctor if any of the following side effects become severe.
Very common (may affect more than 1 in 10 people):
- The cloudy lens in the eye ( cataract ).
Common (may affect up to 1 in 10 people):
- Hole or tear in the retina (the layer at the back of the eye that perceives light) or in one of its layers
- Increased pressure inside the eye (increased intraocular pressure )
- Bleeding from small blood vessels in the outer layer of the eye (conjunctival hemorrhage)
- Moving dots or dark shadows in the field of vision (vitreous opacities)
- Eye pain
- Increased tear production
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/red eye (vitreous)
- Inflammation of the iris and surrounding tissue of the eye ( iritis, iridocyclitis, uveitis )
- Bleeding in the eye (vitreous hemorrhage)
- Scratched cornea, damage to the cornea (the clear layer of the eye that covers the iris [cornealabrasion])
- Eye irritation
- Eye discomfort
- Itchy eyes
- Red-eye (ocular/conjunctival hyperemia )
- A feeling of having caught something in the eye
- Blurred vision
- Decreased visual acuity (impaired vision)
Rare (may affect up to 1 in 1,000 people):
- Retinal detachment
- Temporarily impaired visual acuity (transient reduced visual acuity )
When certain medicines that work in a similar way to Vabysmo are given, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which can lead to heart attack or stroke. Because small amounts of the drug are absorbed into the blood, there is a theoretical risk of such events following the injection of Vabysmo into the eye.
How Vabysmo should be stored
Doctors, pharmacists, or nurses are responsible for storing this medicine and disposing of unused medicine properly. The following information is intended for healthcare professionals.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator at 2 °C-8 °C.
Do not freeze.
Store the vial in the outer carton. Light sensitive.
Before use, the unopened vial can be stored at room temperature, 20°C to 25°C for up to 24 hours.
Contents of the packaging and other information
Contents declaration
- The active substance is faricimab. One ml of solution contains 120 mg of faricimab. Each vial contains 28.8 mg faricimab in 0.24 ml solution. This provides a sufficient amount to deliver a single dose of 0.05 ml solution containing 6 mg faricimab.
- Other ingredients are L-histidine, acetic acid 30%, L-methionine, sodium chloride, sucrose, polysorbate 20, and water for injections.
Appearance and package sizes of the medicine
Vabysmo is clear to opalescent, colorless to the brownish-yellow solution.
Package size with a glass vial and a 5 µm blunt filter transfer cannula (18 G x 1½ in., 1.2 mm x 40 mm), for single use only.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
Grenzach-Wyhlen
79639
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Str 1
Grenzach-Whylen
79639
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| Finland/FinlandRoche OyTel: +358 (0) 10 554 500 |
| SwedenRoche ABPhone: +46 (0) 8 726 1200 |