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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) administered by intravitreal injection every 4 weeks (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). 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) administered by intravitreal injection every 4 weeks (monthly) for the first 4 doses, followed by 6 mg (0.05 mL) via intravitreal injection at intervals of up to every 16 weeks (4 months). 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.
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.
Comprehensive instructions for the administration of VABYSMO are given in the Instructions for Use.
Duration of treatment: VABYSMO is intended for long-term treatment.
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.
Special Dosage Instructions: Pediatric use: The safety and efficacy of VABYSMO in pediatric patients have not been established.
Geriatric use: In the four Phase III clinical studies, approximately 60% (1,149/1,929) of patients randomized to treatment with VABYSMO were ≥ 65 years of age. Population pharmacokinetic analysis has shown an effect of age on ocular pharmacokinetics of faricimab. The effect was considered not clinically meaningful. No dose adjustment is required in patients ≥ 65 years of age (see Use in the Elderly under Precautions and Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).
Renal Impairment: No specific studies in patients with renal impairment have been conducted with VABYSMO. Pharmacokinetic analysis of patients in all clinical studies of which 64% had renal impairment (mild 38%, moderate 24%, and severe 2%), revealed no differences with respect to systemic pharmacokinetics of faricimab after intravitreal administration of VABYSMO.
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.
Other Special Patient Populations: No special dosage modification is required for any of the populations that have been studied (e.g., elderly, gender, race).
