Information for the adult patient

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

1. What Ongavia is and what it is used for

What Ongavia is

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

What Ongavia is used for

Ongavia 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 Ongavia works

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

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

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

You must not receive Ongavia

• 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 Ongavia.

• Ongavia 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 Ongavia 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 Ongavia is the appropriate treatment for you.

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

Children and adolescents (below 18 years of age)

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

Other medicines and Ongavia

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 Ongavia.
• There is no experience of using Ongavia in pregnant women. Ongavia 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 Ongavia.
• Small amounts of Ongavia may pass into breast milk, therefore Ongavia is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Ongavia treatment.

Driving and using machines

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

3. How Ongavia is given

Ongavia 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 Ongavia 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 Ongavia”.

Elderly (age 65 years and over)

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

Before stopping Ongavia treatment

If you are considering stopping Ongavia 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 Ongavia.

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 Ongavia 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 Ongavia 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 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.

5. How to store Ongavia

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

What Ongavia looks like and contents of the pack

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

One pack type is available:

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

Marketing Authorisation Holder

Midas Pharma GmbH
Rheinstraße 49
D-55218 Ingelheim am Rhein
Germany

Manufacturer

Midas Pharma GmbH
Rheinstraße 49
D-55218 Ingelheim am Rhein
Germany

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK (Teva Runcorn)
Aston Lane North, Whitehouse Vale Industrial Estate
Runcorn, Cheshire, WA7 3FA
United Kingdom

This leaflet was last revised in 05/2023

Other sources of information

To request a copy of this leaflet in braille, large print or audio please email:
medinfo@tevauk.com

Please include the following information within your email:
Product name: Ongavia
Reference number: PLGB 18179/0027