Lytenava 25 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 Lytenava is and what it is used for
2. What you need to know before you use Lytenava
3. How to use Lytenava
4. Possible side effects
5. How to store Lytenava
6. Contents of the pack and other information

Lytenava contains the active substance bevacizumab gamma, which belongs to a group of medicines called antineovascularisation agents.

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.

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.

• are allergic to bevacizumab gamma or any of the other ingredients of this medicine (listed in section 6)
• have an infection in or around your eye
• have an inflammation in your eye

Tell your doctor if any of these apply to you.

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.

The use of Lytenava 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 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.

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

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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, schedule a new appointment with your doctor as soon as possible.

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 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:

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 bevacizumab gamma. Each mL contains 25 mg bevacizumab gamma. Each vial contains 7.5 mg of bevacizumab gamma in 0.3 mL solution. This provides a suitable amount to deliver a single dose of 0.05 mL containing 1.25 mg bevacizumab gamma.
• The other ingredients are sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, α,α-trehalose dihydrate, polysorbate 20 (E432), water for injections.

Lytenava 25 mg/mL solution for injection (injection) is colourless to slightly brown.

Pack containing one glass vial with butyl rubber stopper. The vial is for single use only.