ILUVIEN Intravitreal implant Ref.[7965] Active ingredients: Fluocinolone

Posology

The recommended dose is one ILUVIEN implant in the affected eye. Administration in both eyes concurrently is not recommended (see Section 4.4).

Each ILUVIEN implant releases fluocinolone acetonide for up to 36 months.

Diabetic Macular Oedema

An additional implant may be administered after 12 months if the patient experiences decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema (see Section 5.1).

Retreatments should not be administered unless the potential benefits outweigh the risks.

Only patients who have been insufficiently responsive to prior treatment with laser photocoagulation or other available therapies for diabetic macular oedema should be treated with ILUVIEN.

Non-Infectious Uveitis affecting the Posterior Segment

There are no data available to support the retreatment of patients with an additional implant when used for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.

Paediatric population

There is no relevant use of intravitreally administered fluocinolone acetonide in the paediatric population in diabetic macular oedema (DMO).

The safety and efficacy in uveitis in the paediatric population has not been established.

Special populations

No dosage adjustments are necessary in elderly patients, or those with renal or hepatic impairment.

Method of administration

FOR INTRAVITREAL USE ONLY.

Treatment with ILUVIEN is for intravitreal use only and should be administered by an ophthalmologist experienced in intravitreal injections. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anaesthesia and a broad-spectrum microbicide should be given prior to the injection.

The injection procedure for ILUVIEN is as follows:

1. Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.
2. Just prior to injection, administer topical anaesthesia over the injection site (inferotemporal quadrant recommended) as one drop followed by either a cotton-tipped applicator soaked in anaesthetic or as subconjunctival administration of adequate anaesthesia.
3. Administer 2-3 drops of adequate topical antiseptic into the lower fornix. The lids may be scrubbed with cotton-tipped applicators soaked with an adequate topical antiseptic. Place a sterile lid speculum. Have the subject look up and apply a cotton-tipped applicator soaked with an adequate antiseptic to the injection site. Allow 30-60 seconds for the topical antiseptic to dry prior to injection of ILUVIEN.
4. The exterior of the tray should not be considered sterile. An assistant (non-sterile) should remove the tray from the carton and examine the tray and lid for damage. If damaged, do not use unit. If acceptable, the assistant should peel the lid from the tray without touching the interior surface.
5. Visually check through the viewing window of the preloaded applicator to ensure that there is a drug implant inside.
6. Remove the applicator from the tray with sterile gloved hands touching only the sterile surface and applicator. The protective cap on the needle should not be removed until ILUVIEN is ready to be injected. Prior to injection, the applicator tip must be kept above the horizontal plane to ensure that the implant is properly positioned within the applicator.
7. To reduce the amount of air administered with the implant, the administration procedure requires two steps. Before injecting the needle in the eye, push the button down and slide it to the first stop (at the curved black marks alongside the button track). At the first stop, release the button and it will move to the UP position. If the button does not rise to the UP position, do not proceed with this unit.
8. Optimal placement of the implant is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of calipers.
9. Carefully remove the protective cap from the needle and inspect the tip to ensure it is not bent.
10. Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes. Inject the needle in the eye. To release the implant, while the button is in the UP position, advance the button by sliding it forward to the end of the button track and remove the needle. Note: Ensure that the button reaches the end of the track before removing the needle.
11. Remove the lid speculum and perform indirect ophthalmoscopy to verify placement of the implant, adequate central retinal artery perfusion and absence of any other complications. Scleral depression may enhance visualisation of the implant. Examination should include a check for perfusion of the optic nerve head immediately after the injection. Immediate intraocular pressure (IOP) measurement may be performed at the discretion of the ophthalmologist.

Following the procedure, patients should be monitored for potential complications such as endophthalmitis, increased intraocular pressure, retinal detachments, and vitreous haemorrhages or detachments and ocular hypotony (observed up to 8 days post treatment). Biomicroscopy with tonometry should be performed between two and seven days after the implant injection.

Thereafter it is recommended that patients are monitored at least quarterly for potential complications, due to the extended duration of release of fluocinolone acetonide, of approximately 36 months (see Section 4.4).

No case of overdose has been reported.

2 years.

After first opening the lid, use immediately.

Store below 30°C. Do not refrigerate or freeze.

Do not open the sealed tray until just before application.

The implant is supplied in a single use applicator with a 25 gauge needle. Each sterile applicator contains a light brown 3.5 mm long cylindrical implant. The applicator is packaged in a plastic tray sealed with a lid.

Dispose of the applicator safely in a biohazard sharps container.

Any unused product or waste material should be disposed of in accordance with local requirements.