Byooviz 10 mg/ml solution for injection

• 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.

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

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.

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)).

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.

• 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.

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.

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

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

• 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.
• Small amounts of Byooviz may pass into breast milk, therefore Byooviz is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Byooviz treatment.

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

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

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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.

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 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents, and one injection needle (30G x ½″, 0.3 mm x 13 mm). All components are for single use only.

Not all pack types may be marketed.

For any information about this medicine, please contact: