Byooviz - patient leaflet, side effects, dosage

Patient leaflet - Byooviz

B. PACKAGE LEAFLET

Package leaflet: Information for the adult patient

Byooviz 10 mg/ml solution for injection ranibizumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Adults

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 get any side effects, talk to your doctor. This includes any possible side effects not listed in

this leaflet. See section 4.

What is in this leaflet

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

1. What Byooviz is and what it is used for

What Byooviz is

Byooviz is a solution which is injected into the eye. Byooviz belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab.

What Byooviz is used for

Byooviz is used in adults to treat several eye diseases causing vision impairment.

These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by:

– Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related

macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.

– Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes

(a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)).

How Byooviz works

Byooviz specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Byooviz can block its actions and prevent this abnormal growth and swelling.

In these diseases, Byooviz can help to stabilise and in many cases improve your vision.

What you need to know before you are given Byooviz

You must not receive Byooviz

– If you are allergic to ranibizumab 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 or redness (severe intraocular inflammation) in your eye.

Warnings and precautions

Talk to your doctor before you are given Byooviz.

– Byooviz is given as an injection into the eye. Occasionally, an infection in the internal portion of

the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur after Byooviz treatment. It is important to identify and treat such an infection or retinal detachment as soon as possible. Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.

– In some patients the eye pressure may increase for a short period directly after the injection.

This is something you may not notice, therefore your doctor may monitor this after each injection.

– Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you

have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding). This information will be taken into account to evaluate if Byooviz is the appropriate treatment for you.

Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Byooviz therapy.

Children and adolescents (below 18 years of age)

The use of Byooviz in children and adolescents has not been established and is therefore not recommended.

Other medicines and Byooviz

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

Pregnancy and breast-feeding

– Women who could become pregnant must use effective contraception during treatment and for at

least three further months after the last injection of Byooviz.

– There is no experience of using Byooviz in pregnant women. Byooviz should not be used during

pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Byooviz.

– Byooviz is not recommended during breast-feeding because it is not known whether Byooviz

passes into human milk. Ask your doctor or pharmacist for advice before Byooviz treatment.

Driving and using machines

After Byooviz treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.

3. How Byooviz is given

Byooviz is administered as a single injection into your eye by your eye doctor under a local anaesthetic. The usual dose of an injection is 0.05 ml (which contains 0.5 mg of active substance). The interval between two doses injected into the same eye should be at least four weeks. All injections will be administered by your eye doctor.

Before the injection, your doctor will wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.

The treatment is started with one injection of Byooviz per month. Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment.

Detailed instructions for use are given at the end of the leaflet under “How to prepare and administer Byooviz”.

Elderly (age 65 years and over)

Byooviz can be used for people of 65 years of age and over without dose adjustment.

Before stopping Byooviz treatment

If you are considering stopping Byooviz treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Byooviz.

If you have any further questions on 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.

The side effects associated with the administration of Byooviz are either due to the medicine itself or the injection procedure and mostly affect the eye.

The most serious side effects are described below:

Common serious side effects (may affect up to 1 in 10 people): Detachment or tear of the layer in the back of the eye (retinal detachment or tear), resulting in flashes of light with floaters progressing to a temporary loss of sight, or a clouding of the lens (cataract).

Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye.

The symptoms you might experience are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light. Please tell your doctor immediately if you develop any of these side effects.

The most frequently reported side effects are described below:

Very common side effects (may affect more than 1 in 10 people)

Visual side effects include: Inflammation of the eye, bleeding in the back of the eye (retinal bleeding), visual disturbances, eye pain, small particles or spots in your vision (floaters), bloodshot eye, eye irritation, a feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margins, dry eye, redness or itching of the eye and increased eye pressure.

Non-visual side effects include: Sore throat, nasal congestion, runny nose, headache and joint pain.

Other side effects which may occur following Byooviz treatment are described below: Common side effects

Visual side effects include: Decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of eye), small marks on the surface of the eye, blurred vision, bleeding at the site of injection, bleeding in the eye, discharge from the eye with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, swelling of the eyelid, eyelid pain. Non-visual side effects include: Urinary tract infection, low red blood cells count (with symptoms such as tiredness, breathlessness, dizziness, pale skin), anxiety, cough, nausea, allergic reactions like rash, hives, itching and skin reddening.

Uncommon side effects

Visual side effects include: Inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.

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.

5. How to store Byooviz

– 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 vial 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.
– Prior to use, the unopened vial may be stored at temperatures not exceeding 30°C for up to 1 month.
– Keep the vial in the outer carton in order to protect from light.
– Do not use any pack that is damaged.

6. Contents of the pack and other information

What Byooviz contains

– The active substance is ranibizumab. Each ml contains 10 mg ranibizumab. Each vial contains

2.3 mg ranibizumab in 0.23 ml solution. This provides a suitable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.

– The other ingredients are a,a-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine;

polysorbate 20; water for injections.

What Byooviz looks like and contents of the pack

Byooviz is a solution for injection in a vial (0.23 ml). The solution is clear, colourless to pale yellow and aqueous.

Two different pack types are available:

Vial-only pack

Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper. The vial is for single use only.

Vial + filter needle + injection needle pack

Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper, one blunt filter needle (18G x 14", 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents, and one injection needle (30G x 4", 0.3 mm x 13 mm). All components are for single use only.

Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

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

Belgie/Belgique/Belgien

Biogen Belgium NV/S.A

Tél/Tel: + 32 (0)2 808 5947

Etnrapua

Ewopharma AG Representative Office

Ten.: + 359 249 176 81

Česká republika

Biogen (Czech Republic) s.r.o.

Tel: + 420 228 884 152

Danmark

Biogen (Denmark) A/S

Tlf: + 45 78 79 37 53

Deutschland

Biogen GmbH

Tel: + 49 (0)30 223 864 72

Eesti

Ewopharma AG Eesti filiaal

Tel: + 372 6 68 30 56

EZZáSa

Genesis Pharma S.A.

Tql: + 30 211 176 8555

España

Biogen Spain, S.L.

Tel: + 34 931 790 519

France

Biogen France SAS

Tél: + 33 (0)1 776 968 14

Hrvatska

Ewopharma d.o.o

Tel: + 385 (0)1 777 64 37

Ireland

Biogen Idec (Ireland) Ltd.

Tel: +353 (0)1 513 33 33

Ísland

Icepharma hf.

Sími: + 354 800 9836

Italia

Biogen Italia s.r.l.

Tel: + 39 (0)6 899 701 50

Kúnpog

Genesis Pharma (Cyprus) Ltd

Tql: + 357 22 00 04 93

Lietuva

Ewopharma AG Atstovybé

Tel: +370 52 07 91 38

Luxembourg/Luxemburg

Biogen Belgium NV/SA

Tél/Tel: +35 227 772 038

Magyarország

Biogen Hungary Kft.

Tel.: + 36 1 848 04 64

Malta

Pharma.MT Ltd

Tel: + 356 27 78 15 79

Nederland

Biogen Netherlands B.V.

Tel: + 31 (0)20 808 02 70

Norge

Biogen Norway AS

Tlf: + 47 21 93 95 87

Österreich

Biogen Austria GmbH

Tel: + 43 (0)1 267 51 42

Polska

Biogen Poland Sp. z o.o.

Tel.: + 48 22 116 86 94

Portugal

Biogen Portugal Sociedade Farmacéutica,

Unipessoal, Lda

Tel: + 351 308 800 792

Romania

Ewopharma AG Representative Office

Tel: + 40 377 881 045

Slovenija

Biogen Pharma d.o.o.

Tel: + 386 (0)1 888 81 07

Slovenská republika

Biogen Slovakia s.r.o.

Tel: + 421 (0)2 333 257 10

Suomi/Finland

Biogen Finland Oy

Puh/Tel: + 358 (0)9 427 041 08

Sverige

Biogen Sweden AB

Tel: +46 (0)8 525 038 36

Latvija

Ewopharma AG pârstâvniecïba

Tel: + 371 66 16 40 32

United Kingdom (Northern Ireland)

Biogen Idec (Ireland) Ltd.

Tel: +44 (0)20 360 886 22

This leaflet was last revised in

Other sources of information

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

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:

Please also refer to section 3 “How Byooviz is given”.

How to prepare and administer Byooviz to adults|

Single-use vial for intravitreal use only.

Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections.

In wet AMD, in CNV, in PDR and in visual impairment due to DME or to macular oedema secondary to RVO the recommended dose for Byooviz is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml. The interval between two doses injected into the same eye should be at least four weeks.

Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.

Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.

If, in the physician’s opinion, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment, Byooviz should be discontinued.

Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).

If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.

The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year.

Ranibizumab and laser photocoagulation in DME and macular oedema secondary to BRVO

There is some experience of ranibizumab administered concomitantly with laser photocoagulation. When given on the same day, ranibizumab should be administered at least 30 minutes after laser photocoagulation. Ranibizumab can be administered in patients who have received previous laser photocoagulation.

Ranibizumab and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of ranibizumab and verteporfin.

Byooviz should be inspected visually for particulate matter and discoloration prior to administration.

The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure. Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.

Vial-only pack

The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the packaging seal remains intact.

For preparation and intravitreal injection the following medical devices for single use are needed:

– a 5 ^m filter needle (18G)
– an injection needle (30G x 4")
– a 1 ml sterile syringe (including a 0.05 ml mark).

These medical devices are not included within the Byooviz pack.

Vial + filter needle + injection needle pack

All components are sterile and for single use only. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact. Re-use may lead to infection or other illness/injury.