BEOVU 120 mg/mL Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

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

brolucizumab

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

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

Contents of the package leaflet

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

1. What is Beovu and what is it used for

What is Beovu

Beovu contains the active substance brolucizumab, which belongs to a group of medicines called anti-angiogenic agents. Beovu is injected into the eye by a doctor to treat eye conditions that can affect your vision.

What Beovu is used for

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 at the back of the eye, is responsible for clear vision. Abnormal blood vessels can allow fluid or blood to leak into the eye and affect the macula's function, causing diseases that can lead to vision loss, such as:

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

How Beovu works

Beovu can slow down the progression of the disease and help maintain or even improve your vision.

2. What you need to know before you are given Beovu

You should 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 infection or suspect you may have an infection in or around the eye.
• if you have eye pain or redness (eye inflammation).

If you are in any of these situations, tell your doctor. You should not be given Beovu.

Warnings and precautions

Tell your doctor before you are given Beovu if you are in any of these situations:

• if you have glaucoma (an eye condition usually caused by high pressure inside the eye).
• if you have a history of seeing flashes of light or floating particles (floaters) and if you suddenly experience an increase in the size and number of floaters.
• if you have had eye surgery in the last 4 weeks or are scheduled for eye surgery in the next 4 weeks.
• if you have had any eye diseases or treatments in the past.
• if you have a history of sudden vision loss due to blockage of the blood vessels in the back of the eye (retinal vascular occlusion) or inflammation of the blood vessels in the back of the eye (retinal vasculitis) in the last year.

Tell your doctor immediatelyif:

• you experience eye redness, eye pain, increased discomfort, worsening of eye redness, blurred or decreased vision, an increase in the number of small particles in your vision, increased sensitivity to light.
• you experience sudden vision loss, which could be a sign of retinal vascular occlusion.

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

In addition, it is important that you 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, it may increase the risk of side effects.
• injections with Beovu may cause an increase in pressure inside the eye (intraocular pressure) in some patients within 30 minutes 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 layers in the back of the eye (retinal tear or detachment, and retinal pigment epithelial 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 (arterial thromboembolic events), which can lead to a heart attack or stroke. After injection of Beovu into the eye, there is a theoretical risk that these events may occur.

Children and adolescents

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

Other medicines and Beovu

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor before you are given this medicine.

Breastfeeding is not recommended during treatment with Beovu and for at least one month after the end of treatment with Beovu, as it is not known whether Beovu passes into breast milk.

Women of childbearing age must use effective contraceptive methods during treatment and for at least one month after the end of treatment with Beovu. If you become pregnant during treatment or think you may be pregnant, tell 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 temporary visual disturbances (e.g., blurred vision). Do not drive or use machines while these disturbances last.

Beovu contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Beovu contains polysorbates

This medicine contains 0.01 mg of polysorbate 80 per dose (0.05 ml). Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Beovu is given

Dose and frequency of Beovu administration

The recommended dose is 6 mg of brolucizumab.

Exudative age-related macular degeneration (AMD)

Initial treatment (also called loading treatment)

• Treatment will consist of one injection per month for the first 3 months.
• Alternatively, you may 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 starting treatment, depending on the condition of your eye(s).

Maintenance treatment

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

Diabetic macular edema (DME)

• Treatment will consist of one injection every 6 weeks for the first 5 injections.
• Afterwards, you may receive one injection every 3 months. Your doctor will determine the 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 administered by injection into the eye (intravitreal use) by an ophthalmologist.

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

Duration of treatment with Beovu

Beovu is used to treat chronic eye diseases that require long-term treatment, which may last for months or years. During regular follow-up visits, 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 treatment with Beovu, talk to your doctor.

Before stopping treatment with Beovu

Ask your doctor before stopping treatment. Stopping it may increase the risk of vision loss and worsening.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Some side effects can be serious

Get medical help immediately if you have any of the following symptoms, which are signs of allergic reactions, inflammation, or infection:

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

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 usually disappear within a week after each injection.

If these side effects become serious, tell your doctor.

Common:may affect up to 1 in 10 people

• inflammation of the middle layer of the eye wall (uveitis)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• tear of the retina (the light-sensitive part at the back of the eye) or one of its layers (retinal pigment epithelial tear)
• reduced sharpness of vision (decreased visual acuity)
• bleeding in the retina (retinal hemorrhage)
• inflammation of the colored part of the eye (iris inflammation)
• inflammation of the iris or other parts of the eye (iridocyclitis)
• sudden vision loss due to blockage of the blood vessels in the back of the eye (retinal vascular occlusion)
• bleeding in the eye (vitreous hemorrhage)
• clouding of the lens in the eye (cataract)
• bleeding in the eye due to bleeding from small blood vessels in the outer layers of the eye (conjunctival hemorrhage)
• floating particles in the vision (floaters)
• eye pain
• increased pressure inside the eye (increased intraocular pressure)
• redness of the white part of the eye (conjunctivitis)
• blurred or unclear vision
• scratched cornea, damage to the clear layer on the surface of the eyeball that covers the iris (corneal abrasion)
• damage to the clear layer on the surface of the eyeball that covers the iris (punctate keratitis)
• allergic reactions (hypersensitivity)

Uncommon:may affect up to 1 in 100 people

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

Reporting of side effects

If you experience any side effects, tell your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Beovu

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 is the last day of the month shown.

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

Do not freeze.

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

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

6. Container Contents and Additional Information

Composition ofBeovu

• The active substance is brolucizumab. One ml of injectable solution contains 120 mg of brolucizumab. A prefilled syringe contains 19.8 mg of brolucizumab in 0.165 ml of solution. This provides a usable amount that delivers a single dose of 0.05 ml of solution, which contains 6 mg of brolucizumab.
• The other ingredients are: sodium citrate, sucrose, polysorbate 80, sodium hydroxide (for pH adjustment), water for injectable preparations (see section 2).

Appearance and Container Contents of the Product

Beovu 120 mg/ml injectable solution in a prefilled syringe (injectable) is a clear to slightly opalescent, colorless to pale yellow aqueous solution.

The container size is 1 prefilled syringe for single use.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/

This information is intended for healthcare professionals only:

Instructions for Use of the Prefilled Syringe

Storage and Inspection

Preparing and Administering Beovu

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

The intravitreal injection procedure should be performed under aseptic conditions, including surgical hand washing, use of sterile gloves, a sterile field, and a sterile blepharostat (or equivalent) for the eyelids. If necessary, a sterile paracentesis equipment should be available.

Before injection, adequate anesthesia and a broad-spectrum topical microbicide should be administered to disinfect 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 packaging.

Ensure that the injection is administered immediately after dose preparation (step 5).

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

Injection Procedure

Note: The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

Frequently Asked Questions and Answers

Q: What if I cannot remove all 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 generally do not detach from the stopper during injection and therefore do not affect the dose volume.