EYLEA SOLUTION FOR INJECTION IN VIAL 8MG [SIN17040P]

Product Info

EYLEA SOLUTION FOR INJECTION IN VIAL 8MG

[SIN17040P]

4.1 Therapeutic indications

Eylea is indicated in adults for the treatment of

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

• visual impairment due to diabetic macular oedema (DME) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

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

Posology

The recommended dose is 8 mg aflibercept, equivalent to 0.07 ml solution. The posology is the same for the nAMD and DME indications. The 8 mg dose requires use of the Eylea 114.3 mg/ml vial.

Eylea treatment is initiated with 1 injection per month for 3 consecutive doses. Injection intervals may then be extended up to every 4 months based on the physician’s judgement of visual and/or anatomic outcomes. Subsequently, the treatment intervals may be further extended up to 5 months, such as with a treat-and-extend dosing regimen, while maintaining stable visual and/or anatomic outcomes (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly based on the physician’s discretion. The shortest interval between 2 injections is 2 months in the maintenance phase.

Eylea at monthly doses of 8mg has not been studied for more than 3 consecutive doses.

The frequency of monitoring visits should be based on the patient’s status and at the physician’s discretion. For events in which treatment should be withheld see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Special populations

Renal or hepatic impairment
No specific studies in patients with renal or hepatic impairment have been conducted.
Available data do not suggest a need for a dose adjustment with Eylea in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly
Available data do not suggest a need for a dose adjustment with Eylea in these patients.

Paediatric population
The safety and efficacy of Eylea 114.3 mg/ml in children and adolescents below 18 years have not been established. There is no relevant use of Eylea 114.3 mg/ml in the paediatric population in the nAMD and DME indications.

Method of administration

Eylea is for intravitreal injection only.

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 to 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 0.07 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.
After injection, discard any unused product or waste material in accordance with local requirements.

For handling of the medicinal product before administration, see section 6.6 – 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 or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Ocular or periocular infection.

• Active severe intraocular inflammation.