Dexamethasone

Registered South African indications: 

• Visual impairment due to diabetic macular oedema (DME)
  - Who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy
• 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

Contraindications

South African recommendations

• Hypersensitivity to dexamethasone or to any of the ingredients of dexamethasone intravitreal implant
• Active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis) and a history thereof, vaccinia, varicella, mycobacterial infections and fungal diseases. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex and not be used in active ocular herpes simplex
• Advanced glaucoma (where the disease cannot be adequately controlled by medications alone) or uncontrolled glaucoma
• Aphakic eyes with rupture of the posterior lens capsule
• Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated IOLs and ruptured posterior lens capsule
• Communication between vitreous cavity and anterior chamber

Recommendations in other jurisdictions

• 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

Cautions

• Pregnancy
• Breastfeeding
• Bilateral administration
• Retinal ischaemia secondary to retinal vein occlusion

Forms avail. in SA and covered in this monograph: imp

Dosages below are applicable to:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Dexamethasone intravitreal impalnt must be administered by a qualified ophthalmologist experienced in intravitreal injections

Visual impairment due to diabetic macular oedema (DME)
- Who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy

• Intravitreal (imp): 1 implant into affected eye; If retreatment considered necessary: Retreat after approx. 6 months; Max. retreatments: 7 implants

Patients treated with the dexamethasone intravitreal implant who have experienced an initial response and who in the ophthalmologist’s opinion may benefit from retreatment without being exposed to significant risk may 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 no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants

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

• Intravitreal (imp): 1 implant into affected eye; If retreatment considered necessary: Retreat after approx. 6 months; Max. retreatments: 2 implants

Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the ophthalmologist’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 the dexamethasone intravitreal implant , should not be retreated

There is only very limited information on repeat dosing intervals less than 6 months

Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs

All indications: Administration to both eyes concurrently is not recommended. A single-use intravitreal implant in applicator is for intravitreal use only. Each applicator can only be used for the treatment of a single eye

Not indicated for use in children below 18 years

Pregnancy

• Caution
• Studies in animals have shown teratogenic effects following systemic administration. 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 intrauterine 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, intraocular dexamethasone is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus

Breastfeeding

• Caution; not recommended
• 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, intraocular dexamethasone is not recommended during breastfeeding unless clearly necessary

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Migraine

Sensory Disorders

• Intraocular pressure increased 
• Cataract
• Conjunctival haemorrhage
• Ocular hypertension 
• Vitreous haemorrhage 
• Reduced visual acuity 
• Visual impairment/disturbance 
• Vitreous detachment 
• Vitreous floaters
• Vitreous opacities 
• Blepharitis
• Eye pain 
• Photopsia
• Conjunctival oedema
• Conjunctival hyperaemia
• Necrotizing retinitis 
• Endophthalmitis
• Glaucoma
• Retinal detachment 
• Retinal tear
• Hypotony of the eye
• Anterior chamber inflammation 
• Anterior chamber cells/flares 
• Abnormal sensation in eye 
• Eyelid pruritus
• Scleral hyperaemia

Others

• Migration of implant

• CYP3A inhibitors
• Oral corticosteroids
• Anticoagulants
• Antiplatelets

Intraocular pressure

Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting oedema, fibrin deposition, capillary leakage, and phagocytic migration of the inflammatory response. Vascular Endothelial Growth Factor (VEGF) is a cytokine which is expressed at increased concentrations in the setting of macular oedema. It is a potent promoter of vascular permeability. Corticosteroids have been shown to inhibit the expression of VEGF. Additionally, corticosteroids prevent the release of prostaglandins, some of which have been identified as mediators of cystoid macular oedema.

Intraocular injection 700μg

• Ozurdex (Allergan) originator

Also available in the following forms: Eye drop, ear drop and injection.