EYLEA SOLUTION FOR INJECTION IN VIAL 2MG [SIN14345P]

Product Info

EYLEA SOLUTION FOR INJECTION IN VIAL 2MG

[SIN14345P]

4.1 Indication(s)

EYLEA is indicated for the treatment of

• neovascular (wet) age-related macular degeneration (wet AMD) (see section 5.1 “Pharmacodynamic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• macular edema secondary to retinal vein occlusion (branch RVO or central RVO).

• diabetic macular edema (DME).

• myopic choroidal neovascularization (myopic CNV).

4.2 Dosage and method of administration

EYLEA is for intravitreal injection only.

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

4.2.1 Dosage regimen

4.2.1.1 Neovascular (wet) age-related degeneration (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, 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 two months or further extended, such as with using a treat-and-extend dosing regimen, where treatment 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 injections visits.

Treatment intervals greater than 4 months (16 weeks) or shorter than 4 weeks between injections have not been studied (see section “Pharmacodynamic effects” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.1.2 Macular edema secondary to retinal vein occlusion (branch RVO or central RVO)

The recommended dose for EYLEA is 2 mg aflibercept, equivalent to 50 microliters.

After the initial injection, treatment is given monthly until visual and/ or anatomic outcomes are stable. Three or more consecutive, monthly injections may be needed. The interval between two doses should not be shorter than one month.

If there is no improvement in visual and anatomic outcomes over the course of the first three injections, continued treatment is not recommended.

If necessary, treatment may be continued and the interval may be extended based on visual and/ or anatomic outcomes (treat and extend regimen).

Usually, monitoring should be done at the injection visits. During treatment interval extension through to completion of therapy, the monitoring schedule should be determined by the treating physician based on the individual patient’s response and may be more frequent than the schedule of injections.

4.2.1.3 Diabetic macular edema (DME)

The recommended dose for EYLEA is 2 mg aflibercept, equivalent to 50 microliters.

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 the physician’s judgement of 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 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.

EYLEA may be dosed as frequently as once per month (4 weeks).

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.

Treatment intervals shorter than 4 weeks between injections have not been studied (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.1.4 Myopic choroidal neovascularization (myopic CNV)

The recommended dose for EYLEA is a single intravitreal injection of 2 mg aflibercept, equivalent to 50 microliters.

Additional doses should be administered only if visual and anatomic outcomes indicate that the disease persists. Recurrences are treated like a new manifestation of the disease. The monitoring schedule should be determined by the treating physician based on the individual patient’s response. The interval between two doses should not be shorter than one month.
4.2.2 Additional information on special populations

4.2.2.1 Patients with hepatic and/or renal impairment:
No specific studies in patients with hepatic and/or renal impairment were conducted with EYLEA. Available data do not suggest a need for a dose adjustment with EYLEA in these patients (see section 5.2 “Pharmacokinetic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.2.2 Elderly population:
No special considerations are needed.

4.2.2.3 Pediatric population:
Safety and efficacy have not been established in children and adolescents. There is no relevant use of EYLEA in the pediatric population in the indication wet AMD.

4.2.3 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 anesthesia 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, a sterile 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 pre-filled syringe or vial should only be used for the treatment of a single eye.

The pre-filled syringe contains more than the recommended dose of 2 mg (equivalent to 50 microliters solution for injection). The excess volume must be expelled before injecting (see sections "Instruction for use / handling" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Injecting the entire volume of prefilled syringe could result in overdose. To expel the air bubble along with excess medicinal product, slowly depress the plunger to align the base of the plunger dome (not the tip of the dome) with the dosing line on the syringe (equivalent to 50 microlitres i.e. 2 mg aflibercept) (see sections “Overdose”, “Instruction for use/handling” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

After injection any unused product must be discarded.

For handling of the medicinal product, see section 6.6 “Instructions for use / handling” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1 “List of excipients” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Active or suspected ocular or periocular infection.

• Active severe intraocular inflammation.