VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML

INJECTION, SOLUTION

**2.2 DOSAGE AND ADMINISTRATION** **General** For intravitreal injection only. Vabysmo must be administered by a qualified physician experienced in intravitreal injections. Each vial should only be used for the treatment of a single eye. **Neovascular (wet) age-related macular degeneration (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, followed by anatomic and visual acuity evaluations at Week 20 and Week 24 to inform dosing Vabysmo at intervals of 8, 12, or 16 weeks through week 60. The use of Vabysmo beyond Week 60 has not been assessed (see section 3.1.2 Clinical Efficacy Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients should be assessed regularly. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion. **Diabetic macular edema (DME)** The recommended dose for Vabysmo is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks for at least 4 doses or until macular edema is resolved based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography. Thereafter, the dosing interval may be modified using a treat-and-extend approach based on anatomic and/or visual acuity outcomes at dosing visits. The dosing interval may be extended up to every 16 weeks, in up to 4-week increments. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and dosing interval reductions of up to 8 weeks may be implemented if deemed necessary (see section 3.1.2 Clinical Efficacy Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients should be assessed regularly. Monitoring between the dosing visits should be scheduled based on the patient's status and at the physician's discretion. **Method of Administration** Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the vial should not be used. The injection procedure must 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). Adequate anesthesia 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. 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 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. Comprehensive instructions for the administration of Vabysmo are given in the Instructions for Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **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. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, Vabysmo should be discontinued. **Dose Modifications** No dose modifications of Vabysmo are recommended. **2.2.1 Special Dosage Instructions** **Pediatric use** The safety and efficacy of Vabysmo in pediatric patients have not been established. **Geriatric use** No dose adjustment is required in patients ≥ 65 years of age (see section 3.2.5 Pharmacokinetics in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal Impairment** No dose adjustment is required in patients with renal impairment. **Hepatic Impairment** No specific studies in patients with hepatic impairment have been conducted with Vabysmo. However, no special considerations are needed in this population because metabolism occurs via proteolysis and does not depend on hepatic function. No dose adjustment is required in patients with hepatic impairment.