EYLEA Solution for injection Ref.[6096] Active ingredients: Aflibercept

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Bayer AG, 51368, Leverkusen, Germany

Therapeutic indications

Eylea 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).

Posology and method of administration

Eylea is for intravitreal injection only.

Eylea must only be administered by a qualified physician experienced in administering intravitreal injections.

Posology

wet AMD

The recommended dose for Eylea is 2 mg aflibercept, equivalent to 50 microlitres.

Eylea 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 to a minimum of two months during the first 12 months of treatment.

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 between injections have not been studied (see Section 5.1).

Macular oedema secondary to RVO (branch RVO or central RVO)

The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres. 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, Eylea 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

The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.

Eylea 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 Eylea, and based on 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 gradually increased 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 schedule for monitoring should therefore 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, Eylea should be discontinued.

Myopic choroidal neovascularisation

The recommended dose for Eylea is a single intravitreal injection of 2 mg aflibercept equivalent to 50 microlitres.

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.

Special populations

Hepatic and/or renal impairment

No specific studies in patients with hepatic and/or renal impairment have been conducted with Eylea.

Available data do not suggest a need for a dose adjustment with Eylea in these patients (see section 5.2).

Elderly population

No special considerations are needed. There is limited experience in patients older than 75 years with DME.

Paediatric population

The safety and efficacy of Eylea have not been established in children and adolescents. There is no relevant use of Eylea in the paediatric population for the indications of wet AMD, CRVO, BRVO, DME and myopic CNV.

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. The extractable volume of the vial (100 microlitres) is not to be used in total. The excess volume should be expelled before injecting.

Injecting the entire volume of the vial could result in overdose. To expel the air bubble along with excess medicinal product, slowly depress the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres i.e. 2 mg aflibercept).

After injection any unused product must be discarded.

For handling of the medicinal product before administration, see section 6.6.

Overdose

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.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Prior to usage, the unopened vial of Eylea may be stored at room temperature (below 25°C) for up to 24 hours. After opening the vial, proceed under aseptic conditions.

Nature and contents of container

100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle. Pack size of 1.

Special precautions for disposal and other handling

The pre-filled syringe is for single use in one eye only. Do not open the sterile pre-filled blister outside the clean administration room.

Since the pre-filled syringe contains more volume (90 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the syringe has to be discarded prior to the 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.

For the intravitreal injection, a 30 G x 1⁄2 inch injection needle should be used.

Instructions for use of pre-filled syringe

1. When ready to administer Eylea, open the carton and remove the sterilised blister. Carefully peel open the blister ensuring the sterility of its contents. Keep the syringe in the sterile tray until you are ready for assembly.

2. Using aseptic technique, remove the syringe from the sterilised blister.

3. To remove the syringe cap, hold the syringe in one hand while using the other hand to grasp the syringe cap with the thumb and fore finger. Please note: You should snap off (do not turn or twist) the syringe cap.

4. To avoid compromising the sterility of the product, do not pull back on the plunger.

5. Using aseptic technique, firmly twist the injection needle
onto the Luer-lock syringe tip.

6. 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.

7. Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres).

8. The pre-filled syringe is for single use only. Extraction of multiple doses from a pre-filled syringe 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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