Lytenava

This medicinal product must be administered by a qualified healthcare professional, experienced in intravitreal injections. 25 mg administered by intravitreal injection every 4 weeks (monthly). 05 mL. , no change in visual acuity or in other signs and symptoms of the disease under continued treatment.

1) indicate that three or more consecutive monthly injections may be needed initially. Thereafter, the healthcare professional may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters.

g. optical coherence tomography or fluorescein angiography). 3 If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, the medicinal product should be discontinued. 4). Special populations Elderly No dose adjustment is required in patients aged 65 years and older.

Renal impairment Bevacizumab gamma has not been studied in patients with renal impairment. Available data do not suggest a need for a dose adjustment is required in patients with renal impairment. Hepatic impairment Bevacizumab gamma has not been studied in patients with hepatic impairment.

Available data do not suggest a need for a dose adjustment is required in patients with hepatic impairment. Paediatric population There is no relevant use of Lytenava in the paediatric population for the treatment of nAMD. Method of administration The medicinal product is for intravitreal use only.

Each vial should only be used for the treatment of a single eye. 05 mL), a portion of the volume contained in the vial must be discarded prior to administration. Ensure that the injection is given immediately after preparation of the dose.

The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Sterile paracentesis equipment should be available as a precautionary measure.

4). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection. 0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.

Summary of the safety profile The majority of adverse reactions reported following administration of bevacizumab gamma are related to the intravitreal injection procedure. 2%). 3%). 25 mg. The adverse reactions reported in clinical studies of bevacizumab gamma are listed in Table 1 below.

Adverse reactions are listed according to the MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories for each adverse reaction are based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 1 Frequencies of adverse reactions System organ class Common Uncommon Infections and infestations Endophthalmitis Immune system disorders Iodine allergy Eye disorders Vitreous floaters Eye pain Conjunctival haemorrhage Retinal pigment epithelial tear, Vitreous haemorrhage, Iritis, Corneal scar, Keratopathy, Punctate keratitis, Blindness transient, Vitreous detachment, Photopsia, Ocular discomfort, Corneal abrasion, Eye irritation, Eye pruritus, Dry eye, Ocular hyperaemia Investigations Intraocular pressure increased Description of selected adverse reactions Product-class-related adverse reactions There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Proper aseptic injection technique should always be used when administering the medicinal product.

Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available.

In addition, patients should be monitored following the injection to permit early treatment should an infection occur. Patients should be instructed to report any symptoms, such as eye pain, loss of vision, photophobia, blurred vision, floaters, or redness, suggestive of endophthalmitis or any of the above-mentioned events without delay, to permit prompt and appropriate management.

8). Both intraocular pressure and the perfusion of the optic nerve head must be monitored prior to and following intravitreal injection with Lytenava and managed appropriately. Special precaution is needed in patients with poorly controlled glaucoma (do not inject the medicinal product while the intraocular pressure is ≥30 mmHg).

Bilateral treatment The safety and efficacy of bevacizumab gamma administered in both eyes concurrently have not been studied. If bilateral treatment is performed at the same time, this could lead to an increased potential for adverse events, both ocular and systemic due to increased exposure.

Immunogenicity As this is a therapeutic protein, there is a potential for immunogenicity with bevacizumab gamma. Patients should be instructed to inform their physician if they develop symptoms such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light.

1. Patients with active or suspected ocular or periocular infections. Active intraocular inflammation. 4