Country: European Union
Language: English
Source: EMA (European Medicines Agency)
aflibercept
Viatris Limited
S01LA05
aflibercept
Ophthalmologicals
Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications
Yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (AMD) (see section 5.1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),visual impairment due to diabetic macular oedema (DME) (see section 5.1),visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
Revision: 1
Authorised
2023-09-15
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT YESAFILI 40 MG/ML SOLUTION FOR INJECTION IN A VIAL aflibercept This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Yesafili is and what it is used for 2. What you need to know before you are given Yesafili 3. How you will be given Yesafili 4. Possible side effects 5. How to store Yesafili 6. Contents of the pack and other information 1. WHAT YESAFILI IS AND WHAT IT IS USED FOR Yesafili is a solution which is injected into the eye to treat eye conditions in adults called - neovascular (wet) age-related macular degeneration (wet AMD), - impaired vision due to macular oedema secondary to retinal vein occlusion (branch RVO (BRVO) or central RVO (CRVO)), - impaired vision due to diabetic macular oedema (DME), - impaired vision due to myopic choroidal neovascularisation (myopic CNV). Aflibercept, the active substance in Yesafili, blocks the activity of a group of factors, known as vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF). In patients with wet AMD and myopic CNV, these factors, in excess are involved in the abnormal formation of new blood vessels in the eye. These new blood vessels can cause the leak of blood components into the eye and eventual damage to tissues in the eye responsible for vision. In patients with CRVO, a blockage occurs in the main blood vessel that transports blood away from the retina. VEGF levels are elevated in response causing the Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Yesafili 40 mg/mL solution for injection in a vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution for injection contains 40 mg aflibercept*. One vial contains an extractable volume of at least 0.1 mL, equivalent to at least 4 mg aflibercept. This provides a usable amount to deliver a single dose of 0.05 mL containing 2 mg aflibercept. *Fusion protein consisting of portions of human VEGF (vascular endothelial growth factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to pale yellow and iso-osmotic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Yesafili is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1), • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Yesafili is for intravitreal injection only. Yesafili must only be administered by a qualified physician experienced in administering intravitreal injections. Posology _wet AMD _ The recommended dose for Yesafili is 2 mg aflibercept, equivalent to 0.05 mL. Yesafili treatment is initiated with one injection per month for three consecutive doses. The treatment interval is then extended to two months. 3 Based on th Read the complete document