YESAFILI 2 MG / 0.05 ML — DIN 02558238

What is YESAFILI?

YESAFILI 2 MG / 0.05 ML contains AFLIBERCEPT : 2 MG / 0.05 ML. It is listed in the Health Canada Drug Product Database under DIN 02558238, held by BIOSIMILAR COLLABORATIONS IRELAND LIMITED, supplied as SOLUTION for INTRAVITREAL administration. Health Canada currently lists it as marketed, status dated 22-May-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is YESAFILI used for?

YESAFILI (aflibercept, solution for intravitreal injection) is indicated for: • the treatment of neovascular (wet) age-related macular degeneration (AMD) • the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) • the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) • the treatment of diabetic macular edema (DME) • the treatment of myopic choroidal neovascularization (myopic CNV)

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY. Treatment of wet AMD: The recommended dose for YESAFILI is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every month (4 weeks) for the first 3 doses followed by 2 mg (0.05 mL) via intravitreal injection every 2 months (8 weeks). The maximum treatment interval between injections should not exceed 12 weeks in the first year of treatment and not exceed 16 weeks after the first year. Patients should be evaluated regularly. Treatment of CRVO and BRVO: The recommended dose for YESAFILI is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection once every month (4 weeks). The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months (12 weeks) based on visual and anatomic outcomes. Prescribers are advised to periodically assess (every 1 to 2 months) the need for continued therapy. Treatment of DME: The recommended dose for YESAFILI is 2 mg aflibercept (equivalent to 50 microliters solution for injection) administered by intravitreal injection monthly (once every 4 weeks) for the first 5 consecutive doses, followed by one injection every 2 months (8 weeks). Treatment of myopic CNV: The recommended dose for YESAFILI is a single intravitreal injection of 2 mg aflibercept (equivalent to 50 microliters solution for injection). Additional doses should be administered only if visual and/or anatomic outcomes indicate that the disease persists. The interval between two doses should not be shorter than one month (4 weeks). Recurrences are treated like a new manifestation of the disease. Administration: Intravitreal injections must be carried out by a qualified physician experienced in administering intravitreal injections, and according to medical standards and under controlled aseptic conditions. Prior to administration visually inspect the solution for injection. Do not use the pre-filled syringe or vial if particulates, cloudiness, or discolouration are visible. Do not use if any part of the pre-filled syringe is damaged or loose, or if the syringe cap is detached from the Luer-lock. The pre-filled syringe or vial is for single-use only. The pre-filled syringe or vial contents should not be split or further compounded. Use of more than one injection from a pre-filled syringe or vial may increase the risk of contamination and subsequent infection. YESAFILI must only be administered by a qualified physician experienced in administering intravitreal injections. The pre-filled syringe contains more than the recommended dose of 2 mg aflibercept (equivalent to 50 microliters solution for injection). The excess volume must be expelled before injecting. To expel the air bubbles along with excess drug, slowly depress the plunger to align the base of the plunger dome (not the tip of the dome) with the dosing line on the syringe (equivalent to 50 microliters i.e. 2 mg aflibercept). AFTER INJECTION, ANY UNUSED PRODUCT MUST BE DISCARDED.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. • Patients with ocular or periocular infection • Patients with active intraocular inflammation

Warnings and precautions

Hypersensitivity: As with all therapeutic proteins, there is a risk of hypersensitivity reactions including anaphylaxis. Patients should be instructed to report any symptoms of anaphylaxis, allergic reactions or intraocular inflammation (e.g., pain, photophobia, or redness, which, although non-specific, should also be assessed as potential hypersensitivity reactions). Ophthalmologic: Endophthalmitis, Retinal detachments and Cataracts: Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis, retinal detachment, retinal tear, retinal pigment epithelium tear, cataract including traumatic cataract, vitreous hemorrhage and hyphema. Patients should be instructed to report any symptoms suggestive of any event listed above without delay and should be managed appropriately. Retinal vasculitis and Retinal occlusive vasculitis: Retinal vasculitis and retinal occlusive vasculitis have been reported with the use of YESAFILI, typically in the presence of intraocular inflammation or treatment with other intravitreal agents. Patients experiencing any change in vision following treatment should talk to their health professional without delay to determine continuation of treatment. Increase in Intraocular Pressure: Increases in intraocular pressure have been observed within 60 minutes of an intravitreal injection, including with aflibercept. Sustained IOP increases > 21 mm Hg have also been reported. In all cases, both intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately. Aflibercept has not been tested in patients with poorly controlled glaucoma. Other: As with other intravitreal anti-VEGF treatments, treatment should be withheld and resumed only when considered appropriate in cases of: • An IOP of ≥ 30 mmHg • Within the previous or next 28 days in the event of a performed or planned intraocular surgery • A retinal break. The treatment should not be resumed until the break is adequately repaired. Thromboembolic Events: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition. There is a potential risk of ATEs following intravitreal use of VEGF inhibitors, including Aflibercept.