Faricimab

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 ) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO)

• For intravitreal injection
• Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; 2) Weeks 24, 36 and 48; or 3) Weeks 20, 28, 36 and 44
• Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses
• Patients should be assessed regularly
• Diabetic Macular Edema (DME) VABYSMO is recommended to be dosed by following one of these two dose regimens: 1) 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses. …

VABYSMO is a clear to opalescent, colorless to brownish-yellow solution available as: Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single-dose prefilled glass syringe Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single-dose glass vial Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single-dose prefilled syringe ( 3 ) Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single- …

• The safety and efficacy of VABYSMO
• In pediatric patients have not been established

In the six clinical studies, approximately 58% (1,496/2,571) of patients randomized to treatment with VABYSMO were ≥ 65 years of age. No significant differences in efficacy or safety of faricimab were seen with increasing age in these studies. No dose adjustment is required in patients 65 years and above.

• Advise patients that in the days following VABYSMO administration, patients are at risk of developing endophthalmitis, retinal detachment, intraocular inflammation and retinal vasculitis with or without retinal vascular occlusion
• If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions ]
• Patients may experience temporary visual disturbances after an intravitreal injection with VABYSMO and the associated eye examinations [see Adverse Reactions ]
• Advise patients not to drive or use machinery until visual function has recovered sufficiently

• Ocular or periocular infection Active intraocular inflammation Hypersensitivity Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections
• Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation
• Hypersensitivity VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. …

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition. ( 5.3 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including Vabysmo, have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . …

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%). …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of VABYSMO administration in pregnant women. Administration of VABYSMO to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (IV) doses 158 times the human exposure (based on C max ) of the maximum recommended human dose [see Animal Data ] . …

Store VABYSMO in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the sealed tray containing the prefilled syringe or the vial in the original carton to protect from light. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.