VABYSMO

Vabysmo must be administered by a qualified healthcare professional trained in intravitreal injections. Each pre-filled syringe should only be used for the treatment of a single eye. 05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections might be needed.

Thereafter, treatment may be individualised using a treat -and-extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended in increments of up to 4 weeks.

1). Treatment intervals shorter than 21 days and longer than 16 weeks have not been studied. For patients on an intravitreal anti-VEGF therapy who are switching to Vabysmo, the treatment regimen may differ from that recommended for treatment-naïve patients.

When switching a patient from an intravitreal anti-VEGF therapy to Vabysmo, the length of any subsequent treatment interval is at the discretion of the physician based on the patient's anatomic and/or visual outcomes. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion but there is no requirement for monthly monitoring between injections.

Duration of treatment Vabysmo is intended for long-term treatment. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, Vabysmo should be discontinued. Delayed or missed dose If a dose is delayed or missed, the patient should return for assessment at the next available visit and continue dosing depending on physician’s discretion.

2). 2). Hepatic impairment No specific studies in patients with hepatic impairment have been conducted with Vabysmo. 2). Paediatric population The safety and efficacy of Vabysmo in children and adolescents have not been established. No data are available.

Method of administration Single-use pre-filled syringe for intravitreal use only. Vabysmo should be inspected visually for particulate matter and discolouration prior to administration, and if present, the pre-filled syringe should not be used.

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). 8). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.

%), vitreous detachment (4%), IOP increased (4%), vitreous floaters (4%), retinal pigment epithelial tear (nAMD only) (3%), and eye pain (3%). 4). Tabulated list of adverse reactions The adverse reactions reported in clinical studies or during post-marketing surveillance are listed according to the MedDRA system organ class and ranked by frequency using 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) or not known (frequency cannot be estimated from the available data).

Due to the widely varying conditions between studies, the adverse reaction profiles and frequencies reported from the development studies of Vabysmo cannot be directly compared to those reported in other development programs. Within each frequency grouping, adverse drug reactions are presented in order of decreasing frequency.

1% Rare Retinal vasculitis* - - Not known Retinal occlusive vasculitis* - - Not known Terms marked with asterisk (*) are adverse reactions which have been identified based on post-marketing spontaneous reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Description of selected adverse reactions Retinal Vasculitis and Retinal Occlusive Vasculitis Rare cases of retinal vasculitis and/or retinal occlusive vasculitis have been spontaneously reported in the post-marketing setting. Retinal vasculitis and retinal occlusive vasculitis have also been reported in patients treated with IVT therapies.

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. A low incidence rate of arterial thromboembolic events was observed in the Vabysmo clinical trials in patients with nAMD, DMO and RVO.

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 techniques must always be used when administering Vabysmo.

Patients should be instructed to report any symptoms, such as 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). Sustained (present at 2 or more consecutive visits) IOP increases > 21 mm Hg have also been reported. Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the IOP is ≥ 30 mmHg). In all cases, both the IOP and perfusion of the optic nerve head must be monitored and managed appropriately.

Vabysmo has not been studied in patients with poorly controlled glaucoma. Special precaution is needed in patients with poorly controlled glaucoma.

Systemic effects Arterial thromboembolic events (ATE’s):

Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors, including Vabysmo, and there is a theoretical risk that these may be related to VEGF inhibition.

This is similar to that reported in the other clinical trials with anti- VEGF inhibitors in patients. There is limited data on the safety of Vabysmo in patients with history of stroke or transient ischemic attack or myocardial infarction.

8). 8). Bilateral treatment The safety and efficacy of Vabysmo administered in both eyes concurrently have not been studied. , photodynamic therapy) for the treatment of nAMD,DMO and RVO in the same eye. Vabysmo should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).

Ocular or periocular infections. Active intraocular inflammation. 1.