Yesafili Dosage/Direction for Use

Yesafili is for intravitreal injection.
Yesafili must only be administered by a qualified physician experienced in administering intravitreal injections.
Dosage Regimen: Neovascular (wet) age-related macular degeneration (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.
Based on the physician's judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at two months or further extended using a treat-and-extend dosing regimen, where injection intervals are increased in 2- or 4-weekly increments to maintain stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
There is no requirement for monitoring between injections. Based on the physician's judgement the schedule of monitoring visits may be more frequent than the injection visits.
Treatment intervals greater than four months or shorter than 4 weeks between injections have not been studied (see Pharmacology: Pharmacodynamics under Actions).
Macular oedema secondary to RVO (branch RVO or central RVO): The recommended dose for Yesafili is 2 mg aflibercept equivalent to 0.05 mL.
After the initial injection, treatment is given monthly. The interval between two doses should not be shorter than one month.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Yesafili should be discontinued.
Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity. Three or more consecutive, monthly injections may be needed.
Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
The monitoring and treatment schedule should be determined by the treating physician based on the individual patient's response.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Diabetic macular oedema (DME): The recommended dose for Yesafili is 2 mg aflibercept equivalent to 0.05 mL.
Yesafili treatment is initiated with one injection per month for five consecutive doses, followed by one injection every two months. There is no requirement for monitoring between injections.
After the first 12 months of treatment with Yesafili and based on the physician's judgement of visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are usually increased by 2-week increments to maintain stable visual and/or anatomic outcomes. There are limited data for treatment intervals longer than 4 months. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
Treatment intervals shorter than 4 weeks between injections have not been studied (see Pharmacology: Pharmacodynamics under Actions).
The schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Yesafili should be discontinued.
Myopic choroidal neovascularisation (myopic CNV): The recommended dose for Yesafili is a single intravitreal injection of 2 mg aflibercept equivalent to 0.05 mL.
Additional doses may be administered if visual and/or anatomic outcomes indicate that the disease persists. Recurrences should be treated as a new manifestation of the disease.
The schedule for monitoring should be determined by the treating physician.
The interval between two doses should not be shorter than one month.
Additional Information on Special Populations: Patients with Hepatic and/or renal impairment: No specific studies in patients with hepatic and/or renal impairment have been conducted with aflibercept.
Available data do not suggest a need for a dose adjustment with Yesafili in these patients.
Paediatric population: The safety and efficacy have not been established in children and adolescents. There is no relevant use of aflibercept in the paediatric population for the indications of wet AMD, CRVO, BRVO, DME and myopic CNV.
Elderly population: No special considerations are needed for dosing as phase III clinical trials were conducted in this subpopulation (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). There is limited experience in patients older than 75 years with DME.
Method of Administration: Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections. In general, adequate anaesthesia and asepsis, including topical broad-spectrum microbicide (e.g. povidone iodine applied to the periocular skin, eyelid and ocular surface), have to be ensured. Surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) are recommended.
The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered; a different scleral site should be used for subsequent injections.
Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Each vial should only be used for the treatment of a single eye. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.
The vial contains more than the recommended dose of 2 mg aflibercept (equivalent to 0.05 mL solution for injection). The extractable volume of the vial is the amount that can be withdrawn from the vial and is not to be used in total. For the Yesafili vial, the extractable volume is at least 0.1 mL.
(The excess volume must be expelled before injecting the recommended dose) (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
Injecting the entire volume of the vial could result in overdose. To expel the air bubbles along with excess medicinal product, slowly depress the plunger so that the flat plunger edge aligns with the line that marks 0.05 mL on the syringe (equivalent to 0.05 mL i.e. 2 mg aflibercept) (see Overdosage and Special Instructions for Use, Handling and Disposal under Cautions for Usage).
After injection any unused product must be discarded.
For handling of the medicinal product before administration, see Special Instructions for Use, Handling and Disposal under Cautions for Usage.