Vabysmo 6 mg/0.05 ml

INDICATIONS

Faricimab is a bispecific angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of:

Neovascular (wet) age-related macular degeneration (nAMD)
Diabetic macular edema (DME)
Macular edema secondary to retinal vein occlusion (RVO)

PHARMACOLOGY

Faricimab is a humanized bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of two distinct pathways by neutralization of both Ang-2 and vascular endothelial growth factor A (VEGF-A). Ang-2 causes vascular instability by promoting endothelial destabilization, pericyte loss, and pathological angiogenesis, thus potentiating vascular leakage and inflammation. It also sensitizes blood vessels to the activity of VEGF-A resulting in further vascular destabilization. Ang-2 and VEGF-A synergistically increase vascular permeability and stimulate neovascularization. By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability.

DOSAGE & 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) 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.Macular edema secondary to retinal vein occlusion (RVO): The recommended dose for VABYSMO is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly). Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion.

PREGNANCY & LACTATION

There are no data from the use of Faricimab in pregnant women. It is not known whether Faricimab is excreted in human breast milk. No studies have been conducted to assess the impact of Faricimabon milk production or its presence in breast milk.

USE IN SPECIAL POPULATIONS

Pediatric Use: The safety and efficacy of Faricimab 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 totreatment with Faricimab were ≥65, years of age. No significant differences in efficacy or safety of Faricimab were seen with increasing age in these studies.Renal Impairment: No dose adjustment is required in patients with renal impairment.Hepatic Impairment: The safety and efficacy of Faricimab in patients with hepatic impairment has not been studied.

STORAGE CONDITIONS

Storage: 2-8°C. Do not freeze. Keep the vial in the original carton to protect from light.