120 mg / ml injection solution
brolucizumab
1. What Beovu is and what it is used for
What Beovu is
Beovu contains the active substance brolucizumab, which belongs to a group of medicines called antineovascular agents. Beovu is injected into your eye by your doctor for the treatment of a disease called neovascular (wet) age-related macular degeneration (AMD).
What Beovu is used for
Beovu is used in adults to treat neovascular wet AMD that occurs when abnormal blood vessels form and grow below the macula. The macula, which is located in the back of the eye, allows you to see fine details. The abnormal blood vessels can leak fluid or blood into the eye and can interfere with macular function and impair vision.
How Beovu works
A substance called vascular endothelial growth factor A (VEGF ‑ A) causes the abnormal growth of blood vessels in the eye. By binding to VEGF-A, Beovu blocks its effect and reduces the growth of new abnormal blood vessels in AMD, thus reducing the leakage of fluid or blood into the eye.
Beovu can cause the disease to develop more slowly and can thus maintain, or even improve, vision.
2. What you need to know before you get Beovu
You must not be treated with Beovu
- if you are allergic to brolucizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection in or around your eye.
- if you have pain in the eye or have redness in the eye (eye inflammation).
If any of these apply to you, tell your doctor. You should not get Beovu then.
Warnings and cautions
Talk to your doctor or nurse before receiving Beovu, if any of the following apply to you:
- if you have glaucoma (a condition that is usually caused by high pressure in the eye)
- if you have previously seen flashes of light or cloud (dark liquid spots) and if the spots have suddenly become larger and more numerous.
- if you have had eye surgery in the last 4 weeks or will do so within the next four weeks.
- if you have previously had eye diseases or received eye treatments.
Tell your doctor immediately if you:
- causes redness in the eye, increased discomfort, aggravated redness in the eye, blurred vision or impaired vision, increased number of small particles in the field of vision, or increased photosensitivity.
- develops sudden vision loss, which may be a sign of retinal vascular occlusion.
In addition, it is important for you to know:
- The safety and efficacy of Beovu, when administered to both eyes at the same time, have not been studied and that use in this way may lead to an increased risk of side effects.
- Injection with Beovu may cause an increase in intraocular pressure ( intraocular pressure ) in some patients within 30 minutes of injection. Your doctor will monitor this after each injection.
- Your doctor will check if you have other risk factors that may increase the risk of discharge or rupture in any of the layers in the back of the eye (retina or retinal pigment epithelium). In such cases, Beovu must be given with caution.
The systemic use of VEGF inhibitors, substances similar to those found in Beovu, is potentially linked to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which can lead to a heart attack or stroke. There is a theoretical risk of such events after the injection of Beovu into the eye.
Children and young people
Beovu is not given to children and adolescents, as AMD only occurs in adults.
Other drugs and Beovu
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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 taking this medicine.
Breastfeeding is not recommended during treatment with Beovu and for at least one month after stopping treatment with Beovu, as it is unknown whether Beovu is excreted in human milk.
Women who may become pregnant must use effective contraception during treatment and for at least one month after stopping treatment with Beovu. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment.
Driving and using machines
After treatment with Beovu, you may have temporary vision problems (for example, blurred vision). Do not drive or use machines as long as the problems persist.
Beovu contains sodium
The medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium – free’. is next to “sodium-free”.
3. How to get Beovu
How much Beovu is given and how often
The recommended dose is 6 mg brolucizumab.
- You will be treated with an injection every month for the first 3 months.
- After that, you may receive an injection every 3 months. Your doctor will determine the time between treatments depending on how your eye is feeling. Some patients need treatment every two months.
Method of administration
Beovu is given as an injection into the eye (intravitreal use) by an ophthalmologist.
To prevent infection, the doctor thoroughly cleanses the eye before injecting one. You also get eye drops ( local anesthetic ) that numb the eye to reduce or prevent pain from the injection.
How long does treatment with Beovu last?
Wet AMD is a chronic disease and therefore long-term treatment with this drug is needed, for months or years. Your doctor will check that the treatment works when you arrive at your booked visits. Your doctor may also check your eyes between injections. Talk to your doctor if you are wondering how long to continue taking Beovu.
Before stopping treatment with Beovu
Talk to your doctor before stopping treatment. If you stop treatment, the risk of losing your vision may increase and your vision may deteriorate.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. The adverse event was the injection of Beovu come from either the medicine itself or the injection procedure and mostly affect the eye.
Some side effects can be serious
Be sure to get immediate care if you get any of the following, which are signs of allergic reactions, inflammation, or infections:
- Sudden deterioration or change in vision.
- Pain, increased discomfort, aggravated redness in the eye.
If you experience any serious side effect is you should notify your doctor immediately.
Another possible side effect is
Other side effects that may occur after treatment with Beovu are listed below.
Most of the side effects are mild to moderate and generally go away within a week after each injection.
If these side effects get serious, talk to your doctor.
Common: may affect up to 1 in 10 people
- inflammation of the middle membrane of the eye ( uveitis )
- the detachment of the gel-like substance inside the eye (vitreous detachment)
- rupture of the retina (the part in the back of the eye that senses light) or in one of its layers ( rupture of the pigment epithelium)
- impaired vision (impaired visual acuity )
- retinal hemorrhage (retinal hemorrhage)
- inflammation of the iris, the colored part of the eye ( iritis )
- cloud of the lens of the eye ( cataract )
- bleeding from small blood vessels in the outer layer of the eye ( conjunctival bleeding)
- dots moving in the field of view et (clouds in vitreous en)
- eye pain
- higher pressure inside the eye (increased intraocular pressure )
- redness of the whites of the eyes ( conjunctivitis )
- blurred vision or poor visual acuity
- abrasions on the cornea, damage to the clear layer of the eyeball covering the iris(corneal abrasion)
- damage to the clear layer of the eyeball covering the iris (punctate keratitis )
- allergic reactions (hypersensitivity)
Uncommon: may affect up to 1 in 100 people
- severe inflammation inside the eye ( endophthalmitis )
- blindness
- sudden loss of vision due to blockage of an artery in the eye ( occlusion of the retinal artery)
- the detachment of the retina (retinal)
- redness of the eye ( conjunctival hyperemia )
- increased tear production
- abnormal sensation in the eye
- the detachment of one of the layers in the retina (pigment epithelial detachment)
- inflammation of the gel-like substance inside the eye (vitrite)
- inflammation of the anterior part of the eye ( inflammation or “flare” in the anterior chamber)
- inflammation of the iris and its adjacent tissue of the eye ( iridocyclitis )
- swelling of the cornea, clear layers of the eyeball (corneal edema)
- bleeding in the eye (bleeding in vitreous en)
No known frequency (cannot be calculated from the available data):
- sudden loss of vision due to blockage of blood vessels in the back of the eye (retinal vascular occlusion )
- 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store 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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Before use, the unopened vial can be stored at room temperature (below 25 ° C) for up to 24 hours.
6. Contents of the packaging and other information
Content declaration
- The active substance is brolucizumab. One ml solution for injection contains 120 mg of brolucizumab. Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This corresponds to a usable amount sufficient to administer a single dose of 0.05 ml solution, containing 6 mg brolucizumab.
- The other ingredients are sodium citrate, sucrose, polysorbate 80, and water for injections.
What the medicine looks like and the contents of the pack
Beovu 120 mg/ml solution for injection ( injection ) is a clear to slightly opalescent, colorless to the slightly brownish-yellow aqueous solution.
Each pack contains 1 vial and 1 blunt filter needle (18G x 1½ inch, 1.2 mm x 40 mm, 5 μm) for single use only.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4,
Ireland
Manufacturer
SA ALCON-COUVREUR NV
Rijksweg 14
2870 Puurs
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 3754888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |