Dexamethasone implant intravitreal
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Intravitreal implant in applicator containing dexamethasone.
Drugs List
Therapeutic Indications
Uses
Macular oedema following branch or central retinal vein occlusion
Posterior segment non-infectious uveitis
Treatment of visual impairment due to diabetic macular oedema
Dosage
A broad spectrum topical antimicrobial should be given for 3 days prior to and for 3 days after procedure. Adequate local anaesthesia should be administered.
Adults
One implant to be administered intra-vitreally to the affected eye.
DME
Patients treated with this medication 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 for macular oedema should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and who may benefit from retreatment without being exposed to significant risk.
Patients who experience and retain improved vision should not be retreated.
Patients who experience a deterioration in vision, which is not slowed by this medication, should not be retreated.
There is only very limited information on repeat dosing intervals less than 6 months. There is currently no experience of repeat administrations beyond 2 implants in Retinal Vein Occlusion and no experience of repeat administration in posterior segment non-infectious uveitis.
Administration
Single use intravitreal implant in applicator for intravitreal use only.
Each applicator can only be used for the treatment of a single eye; administration to both eyes concurrently is not recommended.
Contraindications
Anterior chamber intraocular lens with posterior lens capsule rupture
Aphakia with posterior lens capsule rupture
Herpes simplex keratitis
Iris fixated intraocular lens with posterior lens capsule rupture
Ocular infection
Periocular infection
Transscleral fixated intraocular lens with posterior lens capsule rupture
Uncontrolled glaucoma
Precautions and Warnings
Recent anticoagulant therapy
Breastfeeding
History of herpes simplex keratitis
Pregnancy
Advise patient blurred vision may affect ability to drive/operate machinery
Premedication with antimicrobial eye drops required 3 days pre & post dose
Treatment of second eye is not recommended within 7 days
Treatment to be administered under the supervision of a specialist
If visual disturbances occur, perform ophthalmic evaluation
Monitor intra-ocular pressure post injection and manage appropriately
Advise patient to report any symptoms of endophthalmitis immediately
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 2 and 7 days following the injection.
Where the posterior capsule of the lens is absent or has a tear, (for example, after cataract surgery) or there is an iris defect (for example, due to iridectomy) there is a risk of implant migration to the anterior chamber. The implant should be used with caution in such patients who should be monitored for any signs of migration.
Increases in intra-ocular pressure may occur which peaks about 60 days after the injection and returns to baseline within 180 days. Regular monitoring is required and treatment prescribed as appropriate. This is more common in patients less than 45 years of age.
Pregnancy and Lactation
Pregnancy
Use dexamethasone intravitreal implants with caution during pregnancy.
The manufacturer notes that this medication should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
There is no adequate data from the use of intravitreally administered dexamethasone in pregnant women. Studies in animals have shown teratogenic effects following topical ophthalmic administration. The systemic exposure of dexamethasone would be expected to be very low after intravitreal implant treatment. One study showed the majority of subjects had plasma levels of dexamethasone that were unquantifiably low. The highest concentration achieved in any subject was 0.094 nanogram/ml. Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child. Dexamethasone crosses the placenta to the foetus.
Lactation
Use dexamethasone intravitreal implants with caution during breastfeeding.
The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the breastfed infant.
Dexamethasone is excreted in breast milk but no effects on the child are anticipated due to the route of administration and the resulting minimal systemic levels.
Side Effects
Abnormal sensation in eye
Anterior chamber flare
Anterior chamber inflammation
Blepharitis
Cataracts
Cells in anterior chamber of eye
Conjunctival haemorrhage
Conjunctival hyperaemia
Conjunctival oedema
Endophthalmitis
Eyelid pruritus
Floaters
Glaucoma
Headache
Increased intra-ocular pressure
Migraine
Necrotising retinitis
Ocular hypertension
Ocular hypotony
Ocular pain
Photopsia
Reddened sclera
Reduced visual acuity
Retinal detachment
Retinal tear
Subcapsular cataract
Visual disturbances
Vitreous detachment
Vitreous haemorrhage
Vitreous opacities
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2014
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Ozurdex. Allergan Ltd. Revised March 2019.
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