Vabysmo Dosage/Direction for Use

General: For intravitreal injection only. Faricimab (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 Faricimab (Vabysmo) is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by 6 mg (0.05 mL) via intravitreal injection at a dosing interval of up to every 16 weeks (4 months). The dosing interval should be based on the physician's judgment of the individual patient's retinal thickness (Central Subfield Thickness, CST) and/or visual acuity. Some patients may be dosed as frequently as every 4 weeks (approximately every 28 ± 7 days, monthly).
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 Faricimab (Vabysmo) is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for the first 4 doses. Thereafter, treatment may be individualised using a treat-and-extend approach. Based on the physician's judgement of the individual patient's CST and/or visual acuity, the dosing interval may be extended up to a maximum of every 16 weeks (4 months), in increments of up to 4 weeks. The treatment interval is to be shortened accordingly in the event of deterioration in the CST and/or visual acuity (see Pharmacology: Pharmacodynamics: Mechanism of Action 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.
Macular edema secondary to retinal vein occlusion (BRVO and CRVO): The recommended dose for Faricimab (Vabysmo) is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, or once a month); three or more consecutive, monthly injections may be needed, until maximum visual acuity is achieved and/or no signs of disease activity are seen. Thereafter, treatment may be individualised using a treat-and-extend approach. Based on the physician's judgement of the individual patient's CST and/or visual acuity, the dosing interval may be extended. The treatment interval is to be shortened accordingly in the event of deterioration in the CST and/or visual acuity and any renewed extension to the treatment interval after stabilisation must be weighed up carefully (see Pharmacology: Pharmacodynamics: Mechanism of Action under Actions). Treatment intervals 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.
Mode of administration: Faricimab (Vabysmo) should be inspected visually for particulate matter and discoloration prior to administration.
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 in the event it 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.
Comprehensive instructions for the administration of Faricimab (Vabysmo) are given in the Instructions for Use under Patient Counselling Information.
Duration of treatment: Faricimab (Vabysmo) is intended for long-term treatment.
Delayed or missed dose: If an injection 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, Faricimab (Vabysmo) should be discontinued.
Dose modifications following undesirable effects/interactions: No dose modifications of Faricimab (Vabysmo) are recommended.
Special Dosage Instructions: Pediatric use: The safety and efficacy of Faricimab (Vabysmo) in pediatric patients have not been established.
Geriatric use: In the six Phase III clinical studies, approximately 58% (1,496/2,571) of patients randomized to treatment with Faricimab (Vabysmo) were ≥65 years of age. Population pharmacokinetic analysis has shown an effect of age on ocular pharmacokinetics of faricimab. But the effect was considered not clinically meaningful. No significant differences in efficacy or safety of faricimab were determined with increasing age in these studies. No dose adjustment is required in patients ≥65 years of age (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Renal impairment: No specific studies in patients with renal impairment have been conducted with Faricimab (Vabysmo) (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
However, no dose adjustment is required in patients with renal disorders.
Hepatic impairment: No specific studies in patients with hepatic impairment have been conducted with Faricimab (Vabysmo) (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
However, no dose adjustment is required in patients with hepatic impairment.
Other special patient populations: No special dosage modification is required for any of the populations that have been studied (e.g., elderly, gender, race).