Patient Information Leaflet: Beovu 120 mg/ml Pre-filled Syringe

brolucizumab

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1.What Beovu is and what it is used for

2.What you need to know before receiving Beovu

3.How Beovu will be given to you

4.Possible side effects

5.Storage of Beovu

6.Contents of the pack and additional information

What is Beovu

Beovu contains the active substancebrolucizumab, which belongs to a group of medicines called anti-neovascularization agents. Beovuis injected into the eye by the doctor to treat eye conditions that may affect your vision.

How is Beovu used

Beovu is used in adults to treat eye conditions that occur when abnormal blood vessels form and grow under the macula. The macula, which is located at the back of the eye, is responsible for clear vision. Abnormal blood vessels may allow fluid or blood to leak into the eye and affect the macula's functioning, causing diseases that may lead to a decrease in vision such as:

• exudative age-related macular degeneration (AMD)
• diabetic macular edema (DME)

How Beovu works

Beovu may slow down the progression of the disease and thereby maintain or even improve your vision.

Do not administer Beovu:

If you find yourself in any of these situations, inform your doctor. Do not administer Beovu.

Warnings and precautions

Consult your doctor before receiving Beovu if you are in any of the following situations:

Inform your doctor immediately if:

Any of the above symptoms may cause your doctor to interrupt your treatment with Beovu.

Also, it is essential to know that:

• the safety and efficacy of Beovu when administered in both eyes at the same time have not been studied and if used in this way may lead to a higher risk of adverse effects.
• Beovu injections may cause an increase in eye pressure (intraocular pressure) in some patients within 30minutes after injection. Your doctor will monitor you after each injection.
• your doctor will check if you have other risk factors that may increase the likelihood of a tear or detachment of one of the posterior layers of the eye (retinal tear or detachment, and retinal pigment epithelium tear or detachment) in which case Beovu will be administered with caution.

The systemic use of VEGF inhibitors, substances similar to those contained in Beovu, is possibly related to the risk of blockage of blood vessels by blood clots (thromboembolic arterial events), which may lead to a heart attack or stroke. After injection of Beovu in the eye, there is a theoretical risk of these events.

Children and adolescents

Beovu is not used in children or adolescents under 18years of age.

Other medications andBeovu

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before receiving this medication.

It is not recommended to breastfeed during treatment with Beovu or at least one month after completing treatment with Beovu because it is unknown if Beovu passes into breast milk.

Women of childbearing age should use effective contraceptive methods during treatment and at least one month after completing treatment with Beovu.If you become pregnant or think you may be pregnant during treatment, inform your doctor immediately. Beovu should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus.

Driving and using machines

After injection with Beovu, you may experience some temporary visual problems (e.g., blurred vision). Do not drive or use machines while these problems last.

Beovu contains sodium

This medicationcontains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free”.

Beovu contains polysorbates

This medication contains 0.01mg of polysorbate80 per dose (0.05ml). Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Quantity and frequency of Beovu administration

The recommended dose is6mg of brolucizumab.

Exudative macular degeneration

Initial treatment (also known as loading treatment)

• The treatment will consist of an injection every month for the first 3 months.
• Alternatively, it could be treated with an injection every 6 weeks for the first two doses. Your doctor will determine if a third injection 12 weeks after starting treatment is necessary based on the condition of your eye(s).

Maintenance treatment

• Subsequently, you may receive an injection every 3months. Your doctor will determine the treatment interval based on the condition of your eye; some patients may need treatment every 2months. Depending on the condition of your eye, your doctor may extend or shorten the treatment interval by no more than 1month at a time. There are limited data for treatment intervals exceeding 5months. The treatment interval between two doses of Beovu should not be less than every 2months.

Macular edema

• The treatment will consist of an injection every 6 weeks for the first 5 injections.
• Subsequently, you may receive an injection every 3months. Your doctor will determine the treatment interval based on the condition of your eye. Some patients may need treatment every 2months. Some patients may receive treatment every 4months.

Administration form

Beovu is administered as an injection into the interior of the eye (intravitreal use) by an ophthalmologist.

Before the injection, your doctor will thoroughly clean your eye to prevent infection. Your doctor will also administer eye drops (local anesthetic) to reduce or prevent pain resulting from the injection.

Duration of Beovu treatment

Beovu is used to treat chronic eye diseases that require long-term treatment, which may last for months or years. In periodic reviews, your doctor will check if the treatment is working. Your doctor may also examine your eyes between injections. If you have any doubts about the duration of Beovu treatment, talk to your doctor.

Before interrupting Beovu treatment

Consult your doctor before interrupting treatment.Suspending it may increase the risk of vision worsening.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects with Beovu injection are due to the medicine itself or components of the injection procedure, and most of them affect the eye.

Some side effects can be serious

Seek immediate medical help if you experience any of the following symptoms, which are signs of allergic reactions, inflammation, or infection:

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

If you experience any serious side effects,consult your doctor immediately.

Other possible side effects

The following is a list of other side effects that may occur after treatment with Beovu.

Most side effects are mild or moderate and generally disappear within a week after each injection.

If these side effects become severe, inform your doctor.

Frequent:may affect up to 1 in 10people

• inflammation of the middle layer of the eye wall (uveitis)
• retinal detachment (separation of the gel-like substance inside the eye)
• retinal tear (damage to the back of the eye that detects light) or tear of one of its layers (retinal pigment epithelium tear)
• reduced visual acuity (decreased sharpness of vision)
• retinal hemorrhage (bleeding in the retina)
• inflammation of the iris, the colored part of the eye (iritis)
• inflammation of the iris or other parts of the eye (iridocyclitis)
• sudden loss of vision due to blockage of blood vessels in the back of the eye (retinal vascular occlusion)
• bleeding in the eye (vitreous hemorrhage)
• clouding of the eye's crystalline lens (cataract)
• blood in the eye due to bleeding of small blood vessels in the outer layers of the eye (conjunctival hemorrhage)
• floaters in vision (moving spots)
• eye pain
• increased intraocular pressure (pressure inside the eye)
• conjunctivitis (redness of the white part of the eye)
• blurred or unclear vision
• corneal abrasion, damage to the transparent layer of the eyeball that covers the iris (corneal abrasion)
• damage to the transparent layer of the eyeball that covers the iris (punctate keratitis)
• allergic reactions (hypersensitivity)

Rare:may affect up to 1 in 100people

• severe inflammation within the eye (endophthalmitis)
• blindness
• sudden loss of vision due to blockage of an artery in the eye (retinal arterial occlusion)
• retinal detachment
• conjunctival hyperemia (redness of the eye)
• increased tear production (excessive lacrimation)
• abnormal sensation in the eye
• retinal pigment epithelium detachment
• inflammation of the gel-like substance inside the eye (vitritis)
• inflammation of the front part of the eye (anterior chamber inflammation)
• corneal edema (swelling of the cornea)
• retinal vasculitis (inflammation of blood vessels in the back of the eye)
• inflammation of the white outer covering of the eye (scleritis)

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in thisleaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after CAD/EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Store the pre-filled syringe in its sealed blister pack and in the outer packaging to protect it from light.

Before use, the unopened blister pack with the pre-filled syringecan be stored at room temperature (below 25°C) for a maximum of 24hours.

Composition ofBeovu

• The active ingredient is brolucizumab. Oneml of injectable solution contains 120mg of brolucizumab. A pre-filled syringe contains 19.8mg of brolucizumab in 0.165ml of solution.This provides a usable amount that provides a single dose of0.05ml of solution,which contains6mg of brolucizumab.
• The other components are:sodium citrate, sucrose, polisorbate 80, water for injection (see section2).

Appearance of the product and contents of the pack

Beovu 120mg/ml injectable solution in pre-filled syringe (injectable) is a transparent to slightly opalescent, colourless to pale yellow aqueous solution.

The pack size is 1pre-filled syringe for single use.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder

Last update of this leaflet:

Other sources of information

The detailed information on thismedicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu/

This information is intended solely for healthcare professionals:

Instructions for use of the pre-filled syringe

Storage and inspection

How to prepare and administerBeovu

The pre-filled syringe contains more than the recommended dose of 6mg. The extractable volume of the pre-filled syringe (0.165ml) should not be administered in its entirety. The excess volume should be expelled before injection. If the entire volume of the pre-filled syringe is injected, it may lead to an overdose.

The intravitreal injection procedure should be carried out under aseptic conditions, including surgical hand washing, the use of sterile gloves, a sterile field, and a sterile eyelid speculum (or equivalent). If necessary, a sterile paracentesis set should be available.

Before injection, an appropriate anaesthesia should be administered and a broad-spectrum topical antimicrobial should be applied to the periocular skin, eyelid, and ocular surface.

For intravitreal injection, a sterile 30G x ½″ injection needle should be used. The injection needle is not included in the Beovu pack.

Ensure that the injection is administered immediately after the dose preparation (step5).

Nota: The dose to be administered should be adjusted to 0.05ml.

Procedure for injection

Nota: The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.

Frequently asked questions

Q: What happens if I cannot remove all the air bubbles from the liquid?

A: It is essential that the liquid is free of air. However, small air bubbles that adhere to the stopper usually do not detach from the stopper during injection and therefore do not affect the volume of the dose.