Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vabysmo

Document Subject

Generated Narrative: MedicinalProductDefinition mp3fd0e71025c97e85a4b382e052756f99

identifier: http://ema.europa.eu/identifier/EU/1/22/1683/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vabysmo 120 mg/mL solution for injection

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3fd0e71025c97e85a4b382e052756f99

identifier: http://ema.europa.eu/identifier/EU/1/22/1683/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vabysmo

Attesters

What is in this leaflet

1. What Vabysmo is and what it is used for
2. What you need to know before you receive Vabysmo
3. How to use Vabysmo
4. Possible side effects
5. How to store Vabysmo
6. Contents of the pack and other information

What Vabysmo is and what it is used for

Vabysmo contains the active substance faricimab, which belongs to a group of medicines called antineovascularisation agents.

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

• neovascular (wet) age-related macular degeneration (nAMD),
• visual impairment due to diabetic macular oedema (DME).

These disorders 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 DME is caused by leaky blood vessels that cause swelling of the macula.

How Vabysmo works

Vabysmo specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present at higher levels than normal, they can cause growth of abnormal blood vessels and/or damage to normal vessels, with leakage into the macula, causing swelling or damage that 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 the disease and/or slow down worsening of the disease and thereby maintain, or even improve, your vision.

You should not receive 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 pain or redness in your eye (eye inflammation).

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 increased 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:

• the safety and efficacy of Vabysmo when administered to both eyes at the same time has not been studied and use in this way may lead to an increased risk of 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.

When some medicines that work in a similar way to Vabysmo are given, there is known to be a risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. As small amounts of the medicine enter the blood, there is a theoretical risk of such events following injection of Vabysmo into the eye.

There is only limited experience in the treatment of:

• patients with active infections.
• patients with nAMD 85 years or older.
• patients with DME due to type I diabetes.
• diabetics with high average blood sugar values (Hb1Ac over 10%).
• diabetics with an eye disease caused by diabetes called proliferative diabetic retinopathy.
• diabetics with high blood pressure greater than 140/90 mmHg and disease of the blood vessels.
• patients with DME receiving injections less than every 8 weeks over a long period of time.

There is only limited experience in the treatment of patients receiving injections less than every 8 weeks over a long period of time, and these patients may be at 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 adolescents

The use of Vabysmo in children and adolescents has not been studied because nAMD and DME 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.

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 .

How Vabysmo is given

The recommended dose is 6 mg of faricimab.

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

• You will be treated with one injection every month for the first 4 months.
• After that, you may receive injections up to every 4 months. Your doctor will decide on the frequency of the injections based on the condition of your eye.

Visual impairment due to diabetic macular oedema (DME)

• You will be treated with one injection every month for the first 4 months.
• After that, you may receive injections up to every 4 months. Your doctor will decide on the frequency of the injections based on the condition of your eye.

Method of administration

Vabysmo is injected into your eye (intravitreal injection) by a doctor experienced in giving eye injections.

Before the injection your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your doctor 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 working. 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.

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, increased eye redness, blurred or decreased vision, a higher number of small particles in your vision, or 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 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):

• Cloudy lens in the eye (cataract)

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

• Tearing of the retina (the layer at the back of the eye that detects light) or one of its layers
• Detachment of the gel-like substance inside the eye (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
• Increased tear production (increased lacrimation)
• Scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion)
• Eye irritation

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/red eye (vitritis)
• Inflammation in the iris and its adjacent tissue in the eye (iritis, iridocyclitis, uveitis)
• Bleeding inside the eye (vitreous haemorrhage)
• Eye discomfort
• Itching (eye pruritus)
• 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

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)

When some medicines that work in a similar way to Vabysmo are given, there is known to be a risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. As small amounts of the medicine enter the blood, there is a theoretical risk of such events following injection of Vabysmo into the eye.

Reporting of side effects

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 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.

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 carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).

Do not freeze.

Keep the vial in the outer 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.

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: L-histidine, acetic acid 30%, L-methionine, sodium chloride, sucrose, polysorbate 20, water for injections.

What Vabysmo looks like and contents of the pack

Vabysmo is a clear to opalescent, colourless to brownish-yellow solution.

Pack size of one glass vial and one sterile 5 m blunt transfer filter needle (18-gauge x 1 inch, 1.2 mm x 40 mm) for single-use only.

Marketing Authorisation Holder

Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer

Roche Pharma AG Emil-Barell-Str 1 79639 Grenzach-Whylen Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 - 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88. France Roche T l: +33 (0)1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: + 385 1 47 22 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: