Ozurdex

/ AbbVie

OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected eye. Administration to both eyes concurrently is not recommended.
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 macularoedema.
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.
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.
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 at the attached doctor’s leaflet.
Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs.
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. 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.

Treatment of adult patients with:
• diabetic macular oedema (DME)
• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
• inflammation of the posterior segment of the eye presenting as non-infectious uveitis.

Hypersensitivity to the active substance or to any of the excipients.
Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Advanced glaucoma which cannot be adequately controlled by medicinal products alone.
Aphakic eyes with ruptured posterior lens capsule.
Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular lens and ruptured posterior lens capsule.

Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment. Proper aseptic injection techniques must always be used. In addition, patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection.
Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the abovementioned events without delay e.g. eye pain, blurred vision etc.
All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or without a history of vitrectomy, are at risk of implant migration into the anterior chamber. Implant migration to the anterior chamber may lead to corneal oedema. Persistent severe corneal oedema
could progress to the need for corneal transplantation. Other than those patients contraindicated where OZURDEX should not be used, OZURDEX should be used with caution and only following a careful risk benefit assessment. These patients should be closely monitored to allow for early diagnosis and management of device migration.
Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections.
In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX underwent cataract surgery in the study eye.
After the first injection, the incidence of cataract appears higher in patients with non-infectious uveitis of the posterior segment compared with BRVO/CRVO patients. In BRVO/CRVO clinical studies, cataract was reported more frequently in patients with phakic lens receiving a second injection. Only 1 patient out of 368 required cataract surgery during the first treatment and 3 patients out of 302 during the second treatment. In the non-infectious uveitis study, 1 patient out of the 62 phakic patients underwent cataract surgery after a single injection.
The prevalence of conjunctival haemorrhage in patients with non-infectious uveitis of the posterior segment appears to be higher compared with BRVO/CRVO and DME. This could be attributable to the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or
Non-steroidal anti-inflammatory medications. No treatment is required since spontaneous resolution occurs.
As expected with ocular steroid treatment and intravitreal injections, increases in intraocular pressure (IOP) may be seen. The rise in IOP is normally manageable with IOP lowering medication. Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest proportion showed this IOP increase between 45 and 60 days following an injection. Therefore, regular monitoring of IOP, irrespective of baseline IOP, is required and any elevation should be managed appropriately post-injection as needed. Patients of less than 45 years of age with macular oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye presenting as non-infectious uveitis are more likely to experience increases in IOP.
Corticosteroids should be used cautiously in patients with a history of ocular viral (e.g. herpes simplex) infection and not be used in active ocular herpes simplex.
The safety and efficacy of OZURDEX administered to both eyes concurrently have not been studied.
Therefore, administration to both eyes concurrently is not recommended.
OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant retinal ischemia. Therefore, OZURDEX is not recommended.
A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 diabetes.
In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no reports of haemorrhagic adverse events in these patients. In DME, anti-coagulant therapy was used in 8% of patients. Among patients who used anti-coagulant therapy, the frequency of haemorrhagic adverse events was similar in the OZURDEX and sham groups (29% vs 32%). Among patients who did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse events compared to 20% in the sham group. Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%).
Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical studies in up to 56% of patients. For patients using concomitant and anti-platelet medication, haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or
number of treatments. The most common haemorrhagic adverse event reported was conjunctival haemorrhage (up to 24%).
OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal products.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

The most commonly-reported adverse events reported following treatment with OZURDEX are those frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract formation and conjunctival or vitreal haemorrhage respectively).
Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing retinitis, retinal detachment and retinal tear.
With the exception of headache and migraine, no systemic adverse drug reactions were identified with the use of OZURDEX.
See prescribing information for full details.

No interaction studies have been performed.
Systemic absorption is minimal and no interactions are anticipated.

Pregnancy: There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women. Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child. Therefore, although the systemic exposure of dexamethasone would be expected to be very low after local, intraocular treatment, OZURDEX is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Lactation: Dexamethasone is excreted in breast milk No effects on the child are anticipated due to the route of administration and the resulting systemic levels. However OZURDEX is not recommended during breast feeding unless clearly necessary.

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