Beovu 120 mg/ml solution for injection in pre-filled syringe
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Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Beovu 120mg/ml solution for injection in a pre-filled syringe
brolucizumab
Read this entire leaflet carefully before you are administered this medicine, because 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 side effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Beovu is and what it is used for
- What you need to know before you are administered Beovu
- How Beovu is administered to you
- Possible side effects
- How to store Beovu
- Contents of the pack and other information
1. What Beovu is and what it is used for
What is Beovu
Beovu contains the active substance brolucizumab, which belongs to a group of medicines called anti-angiogenesis agents. Beovu is injected into the eye by a doctor to treat eye conditions that may 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, located at the back of the eye, is responsible for clear vision. Abnormal blood vessels may leak fluid or blood into the eye and affect the function of the macula, leading to diseases that can cause vision loss, such as:
- exudative age-related macular degeneration (exudative AMD)
- diabetic macular edema (DME)
How Beovu works
Beovu can slow down disease progression and thereby help maintain or even improve your vision.
2. What you need to know before Beovu is administered to you
Do not use Beovu:
- if you are allergic to brolucizumab or to 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 your eye.
- if you have eye pain or redness of the eye (inflammation of the eye).
If you are in any of these situations, inform your doctor. Beovu must not be administered to you.
Warnings and precautions
Talk to your doctor before Beovu is administered to you if you are in any of these situations:
- if you have glaucoma (an eye condition usually caused by increased pressure inside the eye).
- if you have a history of seeing flashes of light or floaters (dark floating spots), or if the size and number of floaters suddenly increase.
- if you have had eye surgery within the last 4 weeks or have scheduled eye surgery within the next four weeks.
- if you have ever had eye diseases or received any eye treatments.
- if you have had sudden vision loss in the past year 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).
Inform your doctor immediately if:
- you experience redness of the eye, eye pain, increased discomfort, worsening redness in the eye, blurred or reduced vision, an increase in the number of small particles in your vision, or increased sensitivity to light.
- you develop sudden vision loss, which could be a sign of retinal vascular occlusion.
Any of the symptoms listed above may lead your doctor to discontinue your treatment with Beovu.
In addition, you should be aware that:
- the safety and efficacy of Beovu when administered in both eyes simultaneously have not been studied, and using it in this way may increase the risk of adverse effects.
- Beovu injections may cause an increase in intraocular pressure (pressure inside the eye) in some patients within 30 minutes after the injection. Your doctor will monitor you after each injection.
- your doctor will check whether you have other risk factors that could increase the likelihood of a tear or detachment of one of the posterior layers of the eye (retinal tear or detachment, or tear or detachment of the retinal pigment epithelium); in such cases, Beovu will be administered with caution.
Systemic use of VEGF inhibitors—substances similar to those contained in Beovu—has been possibly associated with the risk of blood vessel blockage due to blood clots (arterial thromboembolic events), which could lead to myocardial infarction or stroke. After injection of Beovu into the eye, there is a theoretical risk that such events could occur.
Children and adolescents
Beovu is not used in children and adolescents under 18 years of age.
Other medicines and Beovu
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before Beovu is administered.
Breastfeeding is not recommended during treatment with Beovu and for at least one month after treatment with Beovu has ended, as it is unknown whether Beovu passes into breast milk.
Women of childbearing potential must use effective contraceptive methods during treatment and for at least one month after treatment with Beovu has ended. If you become pregnant or suspect 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 use of machines
After receiving a Beovu injection, you may experience temporary visual disturbances (e.g., blurred vision). Do not drive or operate machinery while these disturbances persist.
Beovu contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which 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. Inform your doctor if you have any known allergies.
3. How Beovu is administered
Dose and frequency of Beovu administration
The recommended dose is 6 mg of brolucizumab.
Exudative AMD
Initial treatment (also called loading dose)
- The treatment consists of one injection per month for the first 3 months.
- Alternatively, you may be treated with an injection every 6 weeks for the first two doses. Your doctor will determine whether a third injection is needed 12 weeks after starting treatment, based on the condition of your eye(s).
Maintenance treatment
- Afterwards, you may receive an injection every 3 months. Your doctor will determine the treatment interval based on the condition of your eye; some patients may require 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 available for treatment intervals longer than 5 months. The treatment interval between two Beovu doses must not be less than every 2 months.
DMED
- Treatment consists of an injection every six weeks for the first five injections.
- Afterwards, you may receive an injection every 3 months. Your doctor will determine the treatment interval based on the condition of your eye. Some patients may require treatment every 2 months. Some patients may receive treatment every 4 months.
Method of administration
Beovu is administered as an injection into the eye (intravitreal use) by an ophthalmologist.
Prior to the injection, your doctor will carefully clean your eye to prevent infection. Your doctor will also administer eye drops (local anesthetic) to reduce or prevent pain associated with the injection.
Duration of Beovu treatment
Beovu is used to treat chronic eye diseases requiring long-term treatment, which may last for months or years. During periodic check-ups, your doctor will assess whether the treatment is working. Your doctor may also examine your eyes between injections. If you have any questions about how long your Beovu treatment should last, speak with your doctor.
Before stopping Beovu treatment
Consult your doctor before stopping treatment. Discontinuing treatment may increase the risk of vision loss and worsening of vision.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects with Beovu injection are either due to the medicine itself or are related to the injection procedure, and most of them affect the eye.
Some adverse effects may be serious
Seek immediate medical help if you experience any of the following symptoms, which are signs of allergic reactions, inflammation, or infections:
- sudden decrease or change in vision
- eye pain, increased discomfort, or worsening redness
If you experience any serious adverse effect, contact your doctor immediately.
Other possible adverse effects
Below is a list of other adverse effects that may occur after treatment with Beovu.
Most adverse effects are mild or moderate and usually resolve within one week after each injection.
If any of these adverse effects become severe, inform your doctor.
Frequent: may affect up to 1 in 10 people
- inflammation of the intermediate layer of the eye wall (uveitis)
- detachment of the gel-like substance located inside the eye (vitreous detachment)
- retinal tear (area at the back of the eye that detects light) or of one of its layers (retinal pigment epithelial tear)
- reduced clarity of vision (decreased visual acuity)
- bleeding in the retina (retinal haemorrhage)
- 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 at the back of the eye (retinal vascular occlusion)
- bleeding inside the eye (vitreous haemorrhage)
- clouding of the eye's lens (cataract)
- blood in the eye due to bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage)
- moving spots in 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
- corneal abrasion, damage to the transparent layer covering the iris (corneal abrasion)
- damage to the transparent layer 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 (retinal arterial occlusion)
- retinal detachment
- eye redness (conjunctival hyperemia)
- increased tear production (epiphora)
- 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 at the front of the eye (anterior chamber inflammation or flare)
- corneal swelling, affecting the eye's surface layer (corneal edema)
- inflammation of blood vessels at the back of the eye (retinal vasculitis)
- inflammation of the white outer coating of the eye (scleritis)
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you 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 stated on the carton and label after CAD/EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Do not freeze.
Store the pre-filled syringe in its sealed blister and in the outer packaging to protect it from light.
Before use, the unopened blister containing the pre-filled syringe may be stored at room temperature (below 25 °C) for up to 24 hours.
6. Contents of the pack and other information
Composition of Beovu
- The active substance is brolucizumab. One ml of injectable solution contains 120 mg of brolucizumab. A pre-filled syringe contains 19.8 mg of brolucizumab in 0.165 ml of solution. This provides a usable volume delivering a single dose of 0.05 ml of solution, containing 6 mg of brolucizumab.
- The other components are: sodium citrate, sucrose, polysorbate 80, sodium hydroxide (to adjust pH), water for injections (see section 2).
Nature and contents of the container
Beovu 120 mg/ml solution for injection in pre-filled syringe (injectable) is a transparent to slightly opalescent aqueous solution, colourless to pale yellow.
Pack size: 1 pre-filled syringe for single use.
Marketing Authorisation 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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.
Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11 | Lithuania SIA Novartis Baltics Lithuania Branch Tel: +370 5 269 16 50 |
| Luxembourg/Luxembourg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 |
Czech Republic Novartis s.r.o. Tel: +420 225 775 111 | Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00 |
Denmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Germany Novartis Pharma GmbH Tel: +49 911 273 0 | Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Estonia SIA Novartis Baltics Estonia Branch Tel: +372 66 30 810 | Norway Novartis Norge AS Tlf: +47 23 05 20 00 |
Greece Novartis (Hellas) S.A.E. Tel: +30 210 281 17 12 | Austria Novartis Pharma GmbH Tel: +43 1 86 6570 |
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00 | Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888 |
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00 | Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600 |
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
Iceland Vistor hf. Sími: +354 535 7000 | Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 |
Cyprus Novartis Pharma Services Inc. Τηλ: +357 22 690 690 | Sweden Novartis Sverige AB Tel: +46 8 732 32 00 |
Latvia SIA Novartis Baltics Tel: +371 67 887 070 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/
This information is intended for healthcare professionals only:
Instructions for use of the pre-filled syringe
Storage and inspection
| Store Beovu in the refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the pre-filled syringe in its sealed blister and in the outer packaging to protect it from light. |
| Prior to use, the unopened blister containing the Beovu pre-filled syringe may be stored at room temperature (below 25 °C) for up to 24 hours. Ensure the package contains a sterile pre-filled syringe in a sealed blister. After opening the blister, proceed under aseptic conditions. |
| Beovu is a clear to slightly opalescent aqueous solution, colourless to pale yellow. |
| The solution should be inspected visually after removal from the refrigerator and before administration. If particles or cloudiness are observed, the pre-filled syringe must not be used and appropriate replacement procedures should be followed. The pre-filled syringe is sterile and for single use only. Do not use if the packaging or the pre-filled syringe is damaged or expired. |
How to prepare and administer Beovu
The pre-filled syringe contains more than the recommended 6 mg dose. The extractable volume from the pre-filled syringe (0.165 ml) is not administered in full. The excess volume must be expelled prior to injection. If the entire volume of the pre-filled syringe is injected, it may result in an overdose.
The intravitreal injection procedure must be performed under aseptic conditions, including surgical hand washing, use of sterile gloves, a sterile field, and a sterile eyelid speculum (or equivalent). If necessary, a sterile paracentesis set should be available.
Prior to injection, appropriate anesthesia and a broad-spectrum topical microbicide should be administered to disinfect the skin of the periocular area, eyelids, 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 package.
Ensure that the injection is administered immediately after dose preparation (step 5).
Note: The administered dose must be adjusted to 0.05 ml.
Injection procedure
1. | Remove the blister cap from the syringe and, using an aseptic technique, carefully remove the syringe. |
2.
| Pull and remove the closure cap from the syringe (do not twist or rotate it). |
3. | Using an aseptic technique, firmly attach the 30G x ½″ injection needle to the syringe. |
4.
| Hold the syringe with the needle pointing upward and check for air bubbles inside. If present, gently tap the syringe with your finger until the bubbles rise to the top. Carefully remove the needle cap by pulling it straight off. |
5.
| Hold the syringe at eye level and carefully depress the plunger until the lower edge of the cone-shaped end of the rubber stopper aligns with the 0.05 ml dose mark. This expels air and excess solution, adjusting the dose to 0.05 ml. The syringe is now ready for injection. |
6. | Inject slowly until the rubber stopper reaches the bottom of the syringe, to deliver the 0.05 ml volume. Confirm complete dose administration by verifying that the rubber stopper has reached the end of the syringe. |
Note: Disposal of unused medication and of all materials that have come into contact with it must be carried out in accordance with local regulations.
Frequently asked questions
Q: What should I do if I cannot remove all air bubbles from the liquid?
A: It is important that the liquid is free of air. However, small air bubbles adhering to the stopper generally do not detach from the stopper during injection and therefore do not affect the dose volume.