Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - beovu

Document Subject

Generated Narrative: MedicinalProductDefinition mp8785831d8660f7dc500cb9e2633fcfc2

identifier: http://ema.europa.eu/identifier/EU/1/19/1417/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Beovu 120 mg/ml solution for injection in pre-filled syringe

type: Full name

part

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-8785831d8660f7dc500cb9e2633fcfc2

identifier: http://ema.europa.eu/identifier/EU/1/19/1417/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - beovu

Attesters

What is in this leaflet

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

What Beovu is Beovu contains the active substance brolucizumab, which belongs to a group of medicines called antineovascularisation agents. Beovu is injected into the eye by your doctor to treat eye conditions which may impact your vision.

What Beovu is used for Beovu is used to treat eye conditions in adults which occur when abnormal blood vessels form and grow underneath the macula. The macula, which is at the back of the eye, is responsible for clear vision. The abnormal blood vessels may leak fluid or blood into the eye and interfere with the macula s function, resulting in diseases which may cause decreased vision such as:

• wet age-related macular degeneration (wet AMD)
• diabetic macular oedema (DME)

How Beovu works Beovu may slow down disease progression and thereby maintain, or even improve, your vision.

Abnormal blood vessels that leak fluid or blood into the macula

You must not be given Beovu:

• if you are allergic to brolucizumab 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 applies to you, tell your doctor. You should not be given Beovu.

Warnings and precautions Talk to your doctor before you are given Beovu if any of the following applies to you:

• 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 4 weeks or if eye surgery is planned in the next four weeks.
• if you have ever had any eye diseases or eye treatments.
• if you have a history of sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular occlusion) or inflammation of blood vessels in the back of the eye (retinal vasculitis) in the last year.

Tell your doctor immediately if you:

• develop redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision, increased sensitivity to light.
• develop sudden vision loss, which could be a sign of retinal vascular occlusion. Any of the above symptoms may result in your doctor discontinuing your treatment with Beovu.

Furthermore it is important for you to know that:

• the safety and efficacy of Beovu 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 experiencing side effects.
• injections with Beovu may cause an increase in eye pressure (intraocular pressure) in some patients within 30 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 Beovu must be given with caution.

The systemic use of VEGF inhibitors, substances similar to those contained in Beovu, 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 Beovu into the eye.

Children and adolescents Beovu is not used in children and adolescents.

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

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think that 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 Beovu and for at least one month after stopping treatment with Beovu because it is not known whether Beovu passes into human milk.

Women who could become pregnant must use an effective method of birth control during treatment and for at least one month after stopping treatment with Beovu. If you become pregnant or think you are pregnant during treatment, tell your doctor right away.

Driving and using machines After your injection with Beovu, you may have temporary vision problems (for example blurred vision). Do not drive or use machines as long as these last.

Beovu contains sodium The medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

How much and how often Beovu is given The recommended dose is 6 mg brolucizumab.

Wet AMD Starting treatment (also called loading treatment)

• You will be treated with one injection every month for the first 3 months.
• Alternatively, you could be treated with one injection every 6 weeks for the first two doses. Your doctor will determine if a third injection is needed 12 weeks after treatment start based on the condition of your eye(s). Maintenance treatment
• After that, you may get one injection every 3 months. Your doctor will determine your treatment interval based on the condition of your eye; some patients may need treatment every 2 months. The treatment interval between two doses of Beovu should not be less than every 2 months.

For the first 3 doses,
1 injection every
4 weeks WEEKS 4 3 DOSES,
ONCE EVER Y STARTING TREATMENT (ALSO CALLED LOADING TREATMENT)

MAINTENANCE TREATMENT For the first 2 doses,
1 injection every
6 weeks Y our doctor will determine
if a third injection is needed
12 weeks after treatment start
based on the condition of your eye WEEKS 6 2 DOSES,
ONCE EVER Y OR Then, 1 injection every
12 weeks (3 months)
or as recommended
by your doctor WEEKS ONCE EVER Y DME

• You will be treated with one injection every six weeks for the first five injections.
• After that, you may get one injection every 3 months. Your doctor will determine your treatment interval based on the condition of your eye. Some patients may need treatment every 2 months. Some patients may receive treatment every 4 months.

Method of administration Beovu is given as an injection into your eye (intravitreal use) by an eye doctor.

Before the injection, your doctor will clean your eye carefully, to prevent infection. Your doctor will also give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the injection.

How long does Beovu treatment last for Beovu is used to treat chronic eye diseases which require long-term treatment, possibly continuing for months or years. Your doctor will check that the treatment is working during your regular scheduled visits. Your doctor may also check on your eyes between injections. If you have questions about how long you will receive Beovu, talk to your doctor.

Before stopping Beovu treatment 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 Beovu injection are either from the medicine itself or from the injection procedure and they mostly affect the eye.

Some side effects could be serious Get immediate medical help if you have any of the following, which are signs of allergic reactions, inflammations or infections:

• a sudden decrease or change in vision
• pain, increased discomfort, worsening eye redness

If you have any serious side effects, tell your doctor immediately.

First 5 doses, once every

weeks

For the first 5 doses, 1 injection every 6 weeks

After that, once every

weeks

Then, 1 injection every
12 weeks (3 months) or as recommended by your doctor

Other possible side effects Other side effects which may occur after Beovu treatment include those listed below.

Most of the side effects are mild to moderate and will generally disappear within a week after each injection.

If these side effects become severe, please tell your doctor.

Common: may affect up to 1 in every 10 people

• inflammation of the middle layer of the eye wall (uveitis)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• tearing of the retina (the part at the back of the eye that detects light) or one of its layers (retinal pigment epithelial tear)
• reduced sharpness of vision (reduced visual acuity)
• bleeding in the retina (retinal haemorrhage)
• inflammation of the iris, the coloured part of the eye (iritis)
• inflammation in the iris and its adjacent tissue in the eye (iridocyclitis)
• sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular occlusion)
• bleeding in the eye (vitreous haemorrhage)
• clouding of the lens of the eye (cataract)
• bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage)
• moving spots in your vision (vitreous floaters)
• eye pain
• increase in pressure inside the eye (intraocular pressure increase)
• redness in the white of the eye (conjunctivitis)
• blurred or unclear vision
• scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion)
• damage to the clear layer of the eyeball that covers the iris (punctuate keratitis)
• allergic reactions (hypersensitivity)

Uncommon: may affect up to 1 in every 100 people

• severe inflammation inside the eye (endophthalmitis)
• blindness
• sudden vision loss due to blockage of an artery in the eye (retinal artery occlusion)
• detachment of the retina (retinal detachment)
• redness of the eye (conjunctival hyperaemia)
• increased tear production (lacrimation increased)
• abnormal feeling in the eye
• detachment of one of the layers of the retina (detachment of retinal pigment epithelium)
• inflammation of the gel-like substance inside the eye (vitritis)
• inflammation of the front of the eye (anterior chamber inflammation or flare)
• swelling of the cornea, the clear layer of the eyeball (corneal oedema)
• inflammation of blood vessels in the back of the eye (retinal vasculitis)

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.

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 pre-filled syringe in the sealed blister and in the outer carton in order to protect from light.

Prior to use, the unopened blister with the pre-filled syringe may be kept at room temperature (below 25 C) for up to 24 hours.

What Beovu contains

• The active substance is brolucizumab. One ml solution for injection contains 120 mg brolucizumab. Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
• The other ingredients are: sodium citrate, sucrose, polysorbate 80, water for injections.

What Beovu looks like and contents of the pack Beovu 120 mg/ml solution for injection in a pre-filled syringe (injection) is a clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution.

Pack size of 1 pre-filled syringe for single use only.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer S.A. ALCON-COUVREUR N.V. Rijksweg 2870 Puurs Belgium

Novartis Pharma GmbH Roonstra e 90429 Nuremberg Germany

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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