IZERVAY

2 ). 1 General Dosing Information IZERVAY must be administered by a qualified physician. 1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately every 28 ± 7 days). 3 Preparation for Administration Important information you should know before you begin: • Read all the instructions carefully before using IZERVAY.

• The IZERVAY kit includes a glass vial, filter needle, and an empty syringe. The glass vial, filter needle, and empty syringe are for single use only. • Store IZERVAY in the refrigerator at temperatures between 2ºC to 8ºC (36ºF to 46ºF).

Do not freeze. Do not shake. • Prior to use, allow IZERVAY to reach room temperature, 20⁰C to 25⁰C (68⁰F to 77⁰F). The IZERVAY vial may be kept at room temperature for up to 24 hours. Keep the vial in the original carton to protect from light.

• Use aseptic technique to carry out the preparation of the intravitreal injection. • Each vial should only be used for the treatment of a single eye.

Step 1:

Gather Supplies Gather the following supplies ( see Figure A ): a. One IZERVAY vial (included) b. One sterile 5-micron filter needle 18-gauge x 1½ inch (included) c. 1 mL dose mark (included) d. One sterile injection needle 30‑gauge x ½ inch (not included) NOTE: a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles.

e.

Alcohol swab (not included) Figure A Step 2:

Inspect Vial Inspect the liquid in the vial. It should be a clear to slightly opalescent, colorless to slightly yellow liquid solution ( see Figure B ). Do not use if particulates, cloudiness, or discoloration are visible. Do not use if the packaging, vial, filter needle, injection needle, and/or empty syringe are expired, damaged, or have been tampered with.

Figure B Step 3:

Orient Vial Place the vial upright on a flat surface for about 1 minute after removal from packaging to make sure all liquid settles at the bottom of the vial (see Figure C ) . Gently tap the vial with your finger to remove any liquid that may stick to the top of the vial (see Figure D ) .

1 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of avacincaptad pegol was evaluated in 733 patients with AMD in two sham-controlled studies (GATHER1 and GATHER2). 1 mL of 20 mg/mL solution) [see Clinical Studies (14) ] . Three hundred thirty-two (332) patients were assigned to sham.

Adverse reactions reported in ≥2% of patients who received treatment with IZERVAY for up to 12 months pooled across the GATHER1 and GATHER2 studies are listed below in Table 1 .

Table 1:

Common Ocular Adverse Reactions (≥2%) and greater than Sham in Study Eye up to 12 months 1 Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently. Adverse Drug Reactions IZERVAY N=292 Sham N=332 Conjunctival hemorrhage 13% 9% Increased IOP 9% 1% Blurred vision 1 8% 5% Choroidal neovascularization 7% 4% Eye pain 4% 3% Vitreous floaters 2% <1% Blepharitis 2% <1% Adverse reactions reported in ≥ 2% of patients who received treatment with IZERVAY for up to 24 months in the GATHER2 study are listed below in Table 2 .

Table 2:

Common Ocular Adverse Reactions (≥ 2%) and greater than Sham in Study Eye up to 24 months 1 Blurred vision includes visual impairment, vision blurred, visual acuity reduces, visual acuity reduced transiently and blindness transient.

2 Punctate keratitis includes punctate keratitis and keratitis. Adverse Drug Reactions IZERVAY (N=225) Sham (N=222) Conjunctival hemorrhage 17% 9% Blurred vision 1 14% 5% Increased IOP 13% 1% Choroidal neovascularization 12% 9% Punctate keratitis 2 10% 8% Eye pain 7% 4% Retinal hemorrhage 4% 3% Vitreous floaters 4% <1% Ocular hypertension 4% 0 Blepharitis 3% <1% Corneal abrasion 2% <1% Photopsia, optic ischemic neuropathy, vitreous hemorrhage, vitreal cells, vitritis, and endophthalmitis were each reported in ≤ 1% of patients treated with IZERVAY for up to 24 months across the GATHER1 and GATHER2 studies.

1 ). 3 ). 1) ] . 4) ] . Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Patient Counseling Information (17) ] . 2 Neovascular AMD In the GATHER1 and GATHER2 clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12.

Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.

1) ] . 4) ] .

1 ). 2 ). 1 Ocular or Periocular Infections IZERVAY is contraindicated in patients with ocular or periocular infections. 2 Active Intraocular Inflammation IZERVAY is contraindicated in patients with active intraocular inflammation.