Ozurdex · 4.6 Fertility, pregnancy and lactation · 1

HOS-095538 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile 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. Tabulated list of adverse reactions The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention: Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 Table 1 Adverse reactions System organ class Frequency Adverse reaction Nervous system disorders Common Headache Uncommon Migraine Eye disorders Very common Intraocular pressure increased**, cataract**, conjunctival haemorrhage* Common Ocular hypertension, cataract subcapsular, vitreous haemorrhage**, visual acuity reduced*, visual impairment/disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema* conjunctival hyperaemia* Uncommon Necrotizing retinitis, endophthalmitis*, glaucoma, retinal detachment*, retinal tear*, hypotony of the eye*, anterior chamber inflammation

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HOS-095534 · has-contraindication-information · PDF-Seite 4

• Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1. • 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.

HOS-095533 · has-indication-information · PDF-Seite 2

OZURDEX is indicated for the treatment of adult patients with: • 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) (see section 5.1) • inflammation of the posterior segment of the eye presenting as non-infectious uveitis

HOS-095536 · has-interaction-information · PDF-Seite 6

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

HOS-095537 · has-pregnancy-information · PDF-Seite 6

Pregnancy Studies in animals have shown teratogenic effects following topical ophthalmic administration (see section 5.3). 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. Breast-feeding 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. Fertility There are no fertility data available.

HOS-095535 · has-warning-information · PDF-Seite 4

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 above mentioned events without delay, e.g. eye pain, blurred vision etc. (see section 4.8). 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 and/or corneal decompensation, which, if persistent, could progress to the need for corneal transplantation. Other than those patients contraindicated (see section 4.3) 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 (see section 4.8). 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 (see section 4.8). Only 1 patient out of 368 required cataract surgery during the first treatment and 4 3 patients out of 302 during the second treatment. In the non-infectious uveitis study, 1 patient out of the 62 phakic pati

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