Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Yesafili is indicated for adults for the treatment of
Yesafili is for intravitreal injection only.
Yesafili must only be administered by a qualified physician experienced in administering intravitreal injections.
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 section 5.1).
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).
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.
Based on the physician’s judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at 2 months or individualized, 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 section 5.1).
The schedule for monitoring should be determined by the treating physician.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Yesafili should be discontinued.
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.
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 (see section 5.2).
No special considerations are needed. There is limited experience in patients older than 75 years with DME.
The safety and efficacy of aflibercept 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.
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 section 6.6).
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 sections 4.9 and 6.6).
After injection any unused product must be discarded.
For handling of the medicinal product before administration, see section 6.6.
In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated (see section 6.6).
3 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
The unopened vial may be stored outside the refrigerator below 25°C for up to 24 hours. After opening the vial, proceed under aseptic conditions.
Solution in a vial (type I glass) with a stopper (chlorobutyl rubber). Each vial contains an extractable volume of at least 0.1 mL.
Yesafili is available in 2 different packs:
One pack containing 1 vial and a 5-micron sterile filter needle (18 G × 1½-inch).
One pack containing 1 vial, a 5-micron sterile filter needle (18 G × 1½-inch), a 1 mL Luer-lock syringe and an injection needle (30 G × ½-inch).
Not all pack sizes may be marketed.
The vial is for single use in one eye only.
The vial contains more than the recommended dose of 2 mg aflibercept (equivalent to 0.05 mL). The excess volume must be discarded prior to administration.
The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration. In the event of either being observed, discard the medicinal product.
Preparation for intravitreal injection requires the following medical devices for single use:
Filter needle:
BD blunt 5-micron sterile filter (fill) needle, not for skin injection.
Do not autoclave the BD blunt filter (fill) needle. The filter needle is non-pyrogenic. Do not use it if individual packaging is damaged.
Discard the used BD blunt filter (fill) needle in approved sharps collector.
Caution: Re-use of the filter needle may lead to infection or other illness/injury.
Syringe (where supplied):
BD 1 mL, Luer-lock syringe.
Do not autoclave the BD 1 mL, Luer-lock syringe.
The syringe is non-pyrogenic. Do not use it if individual packaging is damaged. Discard the used BD 1 mL, Luer-lock syringe, with injection needle attached, in approved sharps collector.
Caution: Re-use of the syringe may lead to infection or other illness/injury.
Injection needle (where supplied):
BD 30 G ×½-inch injection needle.
Do not autoclave the BD 30 G ×½-inch injection needle. The injection needle is non-pyrogenic. Do not use it if individual packaging is damaged.
Discard the used BD 30 G ×½-inch injection needle, attached to the syringe, in approved sharps collector.
Caution: Re-use of the injection needle may lead to infection or other illness/injury.
For the intravitreal injection, a 30 G ×½-inch injection needle should be used.
Figure A. Pack size of 1 vial + 1 filter needle + 1 syringe + 1 injection needle:
Figure B. Pack size of 1 vial + 1 filter needle:
1. Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
2. The 18 G ×1½-inch, 5-micron, filter needle is used for withdrawal of drug product from the vial.
Remove the 18 G ×1½-inch, 5-micron, filter needle and the 1 mL syringe from their packaging. Attach the filter needle to the syringe by twisting it onto the Luer lock syringe tip.
3. Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
4. Using aseptic technique withdraw all of the Yesafili vial contents into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal. To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid.
5. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
6. Remove the filter needle and properly dispose of it.
Note: Filter needle is not to be used for intravitreal injection.
7. Ensure the 30 G ×½-inch injection needle is used for the intravitreal injection.
Remove the 30 G ×½-inch injection needle from its packaging and using aseptic technique, firmly twist onto the Luer-lock syringe tip.
8. When ready to administer, remove the plastic needle shield from the needle.
Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top.
9. Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger so that the flat plunger edge aligns with the line that marks 0.05 mL on the syringe.
10. The vial is for single use only. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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