Fovlussea 10 mg/ml solution for injection – patient leaflet, side effects, dosage

1. What Fovlussea is and what it is used for

What Fovlussea is

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

What Fovlussea is used for

Fovlussea 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 Fovlussea works

Fovlussea 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, Fovlussea can block its actions and prevent this abnormal growth and swelling.

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

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

You must not receive Fovlussea

• 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 Fovlussea. - Fovlussea 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 Fovlussea 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 Fovlussea is the appropriate treatment for you.

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

Children and adolescents (below 18 years of age)

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

Other medicines and Fovlussea

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 Fovlussea.

• There is no experience of using Fovlussea in pregnant women.

  Fovlussea 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 Fovlussea.

• Small amounts of Fovlussea may pass into breast milk, therefore

  Fovlussea is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Fovlussea treatment.

Driving and using machines

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

Fovlussea contains sodium

Fovlussea contains less than 1 mmol of sodium per dose, i.e. it is essentially sodium-free.

Fovlussea contains polysorbate

This medicine contains 0.005 mg of polysorbate 20 in each administered dose of 0.05 ml which is equivalent to 0.10 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Fovlussea is given

Fovlussea 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 Fovlussea 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 Fovlussea to adults”.

Elderly (age 65 years and over)

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

IBPLpil-0035

95 0000 0 PM/0000

Vial + filter 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.

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

• a 5 μm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided) - a 1 ml sterile syringe (including a 0.05 ml mark, not included

within the Fovlussea pack)

• an injection needle (30G x ½″; not included within the

  Fovlussea pack)

To prepare Fovlussea for intravitreal administration to adult patients, please adhere to the following instructions:

The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.

After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.

Before stopping Fovlussea treatment

If you are considering stopping Fovlussea 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 Fovlussea.

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 Fovlussea 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 Fovlussea 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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.

5. How to store Fovlussea

• 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 kept at room temperature (25°C) for up to 30 days. Once the vial has been stored at room temperature (25°C), it should not be returned to the refrigerator and be discarded if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.
  • 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 Fovlussea 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 histidine; α,α-trehalose dihydrate;

  polysorbate 20 (E 432); hydrochloric acid; sodium hydroxide; water for injections.

What Fovlussea looks like and contents of the pack

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

Two different pack types are available.

Vial-only pack

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

Vial + filter needle pack

Pack containing one glass vial of ranibizumab with bromobutyl rubber stopper and one blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents. All components are for single use only.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF, United Kingdom

Manufacturers

Accord Healthcare Polska Sp. z.o.o

ul Lutomierska 50, 95-200

Pabianice, Poland

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF, United Kingdom

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia

Schimatari, 32009, Greece

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Accord Healthcare Limited

Tel: +44 (0) 1271 385 257

This leaflet was last revised in July 2026.

If you would like a leaflet with larger text, please contact

01271 385257