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YESAFILI is a brand name for Aflibercept, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between YESAFILI and the reference biologic drug EYLEA®. 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…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 05/2025 7 Warnings and Precautions, Ophthalmologic 05/2025 PATIENT MEDICATION INFORMATION 05/2025 Additional Packaging format 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................
1 Pediatrics ..................................................................................................................... 2 Geriatrics .....................................................................................................................
4 2 CONTRAINDICATIONS .................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration.............................................................................................................
5 Missed Dose .............................................................................................................. 13 5 OVERDOSAGE.............................................................................................................
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). 4 Administration). 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 (see 8 ADVERSE REACTIONS).
3%) patients treated with laser in the BRVO clinical trial. 4% (7/287) of patients initiated treatment with laser. 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 YESAFILI® Product Monograph Page 16 of 73 Unclassified / Non classifié There is only limited experience in the treatment of subjects with DME due to type I diabetes or in diabetic patients with an HbA1c over 12% or with proliferative diabetic retinopathy.
Aflibercept has not been studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole. There is also no experience of treatment with Aflibercept in diabetic patients with uncontrolled hypertension.
General • Treatment with YESAFILI (aflibercept injection) is for intravitreal injection only. Driving and Operating Machinery Patients may experience temporary visual disturbances after an intravitreal injection with YESAFILI and the associated eye examinations.
They should not drive or use machines until visual function has recovered sufficiently. Hepatic/Biliary/Pancreatic YESAFILI has not been studied in patients with hepatic impairment. Immune YESAFILI® Product Monograph Page 15 of 73 Unclassified / Non classifié Hypersensitivity As with all therapeutic proteins, there is a risk of hypersensitivity reactions including anaphylaxis.
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. , 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 (see
• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • Patients with ocular or periocular infection • Patients with active intraocular inflammation
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This lack of information should be considered by the physician when treating such patients. In myopic CNV, a clinical trial was conducted in Japan, South Korea, Singapore, Taiwan and Hong Kong. Thus there is no clinical trial experience with aflibercept in the treatment of non-Asian patients for this indication.
Furthermore, there is also no clinical trial experience in patients who have previously undergone treatment for myopic CNV, and in the patients with extrafoveal lesions. This lack of information should be considered by the physician before treating such patients.
In clinical trials of AMD, CRVO, BRVO and myopic CNV, only one eye per patient was treated with aflibercept. The safety and efficacy of aflibercept therapy administered to both eyes concurrently or consecutively have not been studied.
3 Pharmacokinetics). 1 Pregnancy). Systemic Effects 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.
ATEs, as defined by the Antiplatelet Trialists’ Collaboration (APTC) criteria, include nonfatal myocardial infarction, nonfatal stroke, or vascular death (including deaths of unknown cause). There are limited data on safety in the treatment of patients with CRVO, BRVO, DME or myopic CNV with a history of stroke or transient ischemic attacks or myocardial infarction within the last 6 months.
2% (19 out of 595) in patients treated with ranibizumab. 4% (2 out of 142) in the group of patients receiving only sham treatment. 2% (2 out of 92) in the laser + Aflibercept control group through week 52. One of these patients in the laser group had received Aflibercept rescue treatment.
7% (22 out of 287) at Week 148 in the combined group of patients treated with Aflibercept and in the control (laser) group, respectively. 4% (4 out of 287) at Week 148 in the combined Aflibercept groups and in the control (laser) group, […]