Medicine guide
Lytenava
·
- Prescription status not stated
- Eyes and ears
- Active substance
- Bevacizumab
- Used in
- Eyes and ears
- Made by
- Outlook Therapeutics NL B. V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- What Lytenava is Lytenava contains the active substance bevacizumab gamma, which belongs to a group of medicines called antineovascularisation agents.
- What Lytenava is used for Lytenava is used in adults to treat an eye condition called neovascular (wet) age-related macular degeneration (nAMD).
- This eye condition is characterised by the abnormal formation and growth of blood vessels underneath the macula. The macula is the central part of the retina at the back of the eye and is responsible for clear vision. The abnormal growth and formation of blood vessels may leak fluid or blood into the eye and interfere with the macula’s function.
- How Lytenava works Lytenava specifically binds to a protein called human vascular endothelial growth factor A (VEGF-A), which is present in the eye. In excess, this growth factor causes abnormal growth of blood vessels in the eye, which can reduce vision. By binding to this growth factor, Lytenava can block its actions and prevent abnormal growth. This can help to stabilise or improve your vision.
From the package leaflet in EMA’s product information, p. 22 · 2026-08-03
How to take it
These directions are for this exact strength and form. Another one is different.
- Lytenava is given as a single injection into your eye by your doctor. The usual dose of an injection is 0.05 mL (which contains 1.25 mg of bevacizumab gamma). The interval between two doses injected into the same eye should be about four weeks.
- 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 starts with one injection of Lytenava every 4 weeks. After the first few treatments (about 3), your doctor will determine the frequency of further treatments by monitoring the condition of your eye, such as your vision and the health of your eye. .
- How long does Lytenava treatment last for This is a long-term treatment, possibly continuing for months or years. Your doctor will check that the treatment is working during your regular scheduled visits. Your doctor may also check on your eyes between injections. If you have questions about how long you will receive Lytenava, talk to your doctor.
- If you miss a dose of Lytenava If you miss a dose, schedule a new appointment with your doctor as soon as possible.
- Before stopping Lytenava treatment If you are considering stopping Lytenava 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 Lytenava. Stopping treatment may increase your risk of vision loss and your vision may worsen.
- If you have any further questions on the use of this medicine, ask your doctor.
From the package leaflet in EMA’s product information, p. 24.
Warnings and precautions
- Talk to your doctor before using Lytenava if you have:
- glaucoma, an eye condition usually caused by high eye pressure
- a history of seeing flashes of light or floater or a sudden increase in the size and number of floaters (small, dark shapes moving in the field of vision)
- had blocked blood vessels, caused by a blood clot, such as heart attack, stroke, blood clots formed in the deep veins of the legs or lungs
- had eye surgery in the last 4 weeks or an eye surgery is planned in the next 4 weeks
- ever had any eye diseases or eye treatments Tell your doctor immediately if you have:
- sudden vision loss
- signs of an eye infection or inflammation, such as
- worsening of eye redness or increased eye discomfort
- increased number of floaters in your vision or sensitivity to light
- eye pain
- blurred or decreased vision It is important to know:
- safety and efficacy of Lytenava given to both eyes at the same time has not been studied. Such use may increase risk of side effects.
- injections with Lytenava may cause a temporary increase in eye pressure within 60 minutes after injection. Your doctor will monitor this after each injection.
- your doctor will check for factors increasing risk of a tear or detachment of one of the layers at back of the eye When some other medicines that work in a similar way to Lytenava are given, there is a risk for the formation of blood clots that can block blood vessels. This may lead to heart attack or stroke. As small amounts of the medicine enter the blood, there is a theoretical risk of such events following injection of Lytenava into the eye.
- Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Lytenava therapy.
- Children and adolescents under 18 years The use of Lytenava in children and adolescents has not been established and is therefore not recommended.
From the package leaflet in EMA’s product information, p. 23.
Pregnancy and breastfeeding
- Women who could become pregnant must use effective contraception during treatment and for at least three months after the last injection of Lytenava.
- There is no experience of using bevacizumab gamma in pregnant women. Lytenava is not recommended 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 starting treatment with Lytenava.
- Lytenava is not recommended during breast-feeding because it is not known whether bevacizumab gamma passes into breast milk. Ask your doctor or pharmacist for advice before Lytenava treatment.
From the package leaflet in EMA’s product information, p. 23.
Other medicines
Tell your doctor if you are using, have recently used, or might use any other medicines.
From the package leaflet in EMA’s product information, p. 23.
Driving and using machines
- After Lytenava treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.
- Lytenava contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
From the package leaflet in EMA’s product information, p. 23–24.
Side effects
- Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Side effects of Lytenava injection result from either the medicine itself or the injection procedure and mostly affect the eye.
- Contact your doctor immediately if you have any of the following serious side effects:
- increased eye pressure that requires immediate intervention (uncommon, may affect up to 1 in 100 people)
- serious inflammation inside the eye often caused by infections, called endophthalmitis, or (uncommon, may affect up to 1 in 100 people)
- temporary blindness (uncommon, may affect up to 1 in 100 people)
- Symptoms of these serious side effects are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, increased number of small particles in your vision or increased sensitivity to light.
- Other possible side effects are:
- Common (may affect up to 1 in 10 people)
- small particles or spots in your vision (vitreous floaters)
- eye pain
- bleeding in the protective layer covering the eye called conjunctiva (conjunctival haemorrhage)
- increased eye pressure Uncommon (may affect up to 1 in 100 people)
- detachment or tear of one of the layers in the back of the eye (retinal pigment epithelial tear, vitreous detachment)
- bleeding in the eye
- inflammation of the iris, the coloured part of the eye (iritis)
- corneal scar
- inflammation or damage to the cornea, the clear layer covering the iris (keratopathy, punctate keratitis)
- perceived flashes of light in the field of vision (photopsia)
- eye discomfort
- scratching of the cornea (corneal abrasion)
- eye irritation
- itching of the eye (eye pruritus)
- dry eye
- red eye (ocular hyperaemia)
- iodine allergy 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.
From the package leaflet in EMA’s product information, p. 24–25.
How to store it
- Your doctor, pharmacist, or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals.
- 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.
- The unopened vial may be stored outside the refrigerator below 25 °C for up to 12 hours.
- Keep the vial in the outer carton in order to protect from light.
From the package leaflet in EMA’s product information, p. 25.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Outlook Therapeutics NL B. V. |
|---|---|
| Active substance | Bevacizumab |
| Used in | Eyes and ears |
| Classification | S01LA08 · Eyes and ears |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2024-05-27 |
| Last updated by the regulator | 2026-08-03 |
| EMA product number | EMEA/H/C/005723 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
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