Vabysmo Dosage/Direction for Use

Vabysmo must be administered by a qualified healthcare professional trained in intravitreal injections. Each vial should only be used for the treatment of a single eye.
Posology: nAMD: The recommended dose for Vabysmo is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks for the first 4 doses.
Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 20 and/or 24 weeks after treatment initiation so treatment can be individualised. In patients without disease activity, administration of Vabysmo every 16 weeks should be considered. In patients with disease activity, treatment every 8 weeks or 12 weeks should be considered.
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.
DMO: The recommended dose for Vabysmo is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks for the first 4 doses.
Thereafter, treatment may be individualised using a treat-and-extend approach following an assessment of the individual patient's anatomic and visual outcomes. The dosing interval may be extended from every 4 to every 16 weeks, with extensions in increments of up to 4 weeks, based on the physician's judgement of the individual patient's anatomic and/or visual outcomes. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reductions of up to 8 weeks may be implemented if deemed necessary (see Pharmacology: Pharmacodynamics under Actions).
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.
Special populations: Elderly (≥65 years): No dose adjustment is required in patients aged 65 years or above (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No specific studies in patients with hepatic impairment have been conducted with Vabysmo. No dose adjustment is required in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
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 vial for intravitreal use only.
Vabysmo should be inspected visually for particulate matter and discolouration prior to administration, and if present, the vial 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). The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see Adverse Reactions). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections.
After injection, any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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. Sterile equipment should be available in case paracentesis is required.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay.
For instructions on handling of the medicinal product before administration, see Special precautions for disposal under Cautions for Usage.