OZURDEX Intravitreal implant in applicator Ref.[6765] Active ingredients: Dexamethasone

OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Posology

The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected eye. Administration to both eyes concurrently is not recommended (see section 4.4).

DME

Patients treated with OZURDEX who have experienced an initial response and in the physician’s opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment.

Retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular oedema.

There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants.

RVO and uveitis

Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician’s opinion may benefit from retreatment without being exposed to significant risk (see section 5.1).

Patients who experience and retain improved vision should not be retreated. Patients who experience deterioration in vision, which is not slowed by OZURDEX, should not be retreated.

There is only very limited information on repeat dosing intervals less than 6 months (see section 5.1).

For information concerning the current safety experience of repeat administrations beyond 2 implants in posterior segment non-infectious uveitis and Retinal Vein Occlusion, see section 4.8.

Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs (see section 4.4).

Special populations

Elderly (≥65 years old)

No dose adjustment is required for elderly patients.

Renal impairment

OZURDEX has not been studied in patients with renal impairment however no special considerations are needed in this population.

Hepatic impairment

OZURDEX has not been studied in patients with hepatic impairment; however no special considerations are needed in this population.

Paediatric population

There is no relevant use of OZURDEX in the paediatric population in

• Diabetic macular oedema.
• Macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).

The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been established. No data are available.

Method of administration

OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only.

Each applicator can only be used for the treatment of a single eye.

The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).

The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days before and after each injection. Before the injection, the periocular skin, eyelid and ocular surface should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should be administered. Remove the foil pouch from the carton and examine for damage (see section 6.6). Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. Carefully remove the cap from the applicator. Once the foil pouch is opened the applicator should be used immediately.

Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab. With the bevel of the needle up away from the sclera, advance the needle about 1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the silicone sleeve is against the conjunctiva. Slowly press the actuator button until an audible click is noted. Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and has locked flush with the applicator surface. Remove the needle in the same direction as used to enter the vitreous.

Immediately after injecting OZURDEX, use indirect ophthalmoscopy in the quadrant of injection to confirm successful implantation. Visualisation is possible in the large majority of cases. In cases in which the implant cannot be visualised, take a sterile cotton bud and lightly depress over the injection site to bring the implant into view.

Following the intravitreal injection patients should continue to be treated with a broad spectrum antimicrobial.

If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Each pack contains:

One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.

The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place by a sleeve (silicone). The plunger is controlled by a lever on the side of the applicator body. The needle is protected by a cap and the lever by a safety tab.

The applicator containing the implant is packaged in a sealed foil pouch containing desiccant.

OZURDEX is for single use only.

Each applicator can only be used for the treatment of a single eye.

If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used.

Once the foil pouch is opened the applicator should be used immediately.

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