Vabysmo Dosage/Direction for Use

This medicinal product must be administered by a qualified physician experienced in intravitreal injections.
Posology: Neovascular (wet) age-related macular degeneration (nAMD): The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses.
Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 16 and/or 20 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of faricimab every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate (see Pharmacology: Pharmacodynamics under Actions). There is limited safety data on treatment intervals of 8 weeks or less between injections (see Precautions). 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.
Visual impairment due to diabetic macular oedema (DME) and macular oedema secondary to retinal vein occlusion (RVO): The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed.
Thereafter, treatment is 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. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate (see Pharmacology: Pharmacodynamics under Actions). Treatment intervals shorter than 4 weeks and longer than 4 months between injections have not been studied. 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: This medicinal product is intended for long-term treatment.
If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, treatment should be discontinued.
Delayed or missed dose: If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician's discretion.
Special populations: Elderly: No dose adjustment is required in patients aged 65 years or above (see Pharmacology: Pharmacokinetics under Actions). Safety data in nAMD and RVO patients ≥85 years is limited (see Precautions).
Renal impairment: No dose adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of this medicinal product in the paediatric population for the indications of nAMD, DME, and RVO.
Method of administration: For intravitreal use only. Each vial should only be used for the treatment of a single eye.
Vabysmo should be inspected visually for particulate matter and discoloration 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, 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.
Vial: The injection needle (30-gauge x ½ inch, not included in the package) 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.
Post-injection monitoring: 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. If required, sterile equipment for paracentesis should be available.
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.