Jetrea

JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections. The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT).

3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is required. 1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose. Each vial should only be used once and for the treatment of a single eye.

Treatment with JETREA in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye. 4). 4 for instructions on post-injection monitoring.

Special populations Renal impairment No formal studies have been conducted with JETREA in patients with renal impairment. 2). Hepatic impairment No formal studies have been conducted with JETREA in patients with hepatic impairment. 2).

Medicinal product no longer authorised 3 Elderly The elderly population has been studied in clinical studies. No dose adjustment is required. Paediatric population There is no relevant use of JETREA in children aged under 18 years for the indication of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

1. Method of administration Single use vial for intravitreal use only. Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist. Precautions to be taken before handling or administering the medicinal product The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).

The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice. 3 mL solution in the vial should be administered.

125 mg of JETREA in interventional clinical studies. All adverse reactions were ocular. In 3 clinical studies with follow-up from 6 months (TG-MV-006 and TG-MV-007) to 24 months (TG-MV-014), the most commonly reported adverse reactions were vitreous floaters, eye pain, photopsia and chromatopsia as well as conjunctival haemorrhage resulting from the injection procedure.

Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild to moderate in intensity and resolved within 2 to 3 weeks. Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions’ section.

The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression. Tabulated list of adverse reactions The following table summarises the adverse reactions reported in the treated eye in clinical studies and/or from post-marketing experience.

Visual symptoms perceived in the contralateral eye or bilaterally have also been reported. The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA system organ class and frequency 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) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Medicinal product no longer authorised 6 Eye disorders Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia* Common Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, retinal degeneration, macular oedema3), retinal oedema4), retinal pigment epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, lacrimation increased Uncommon Blindness transient, lens subluxation*, retinal tear*5), retinal detachment*5), night blindness, pupillary reflex impaired, diplopia, hyphaema, miosis, pupils unequal, corneal abrasion, anterior chamber inflammation, eye inflammation, conjunctival irritation Investigations Very common Retinogram abnormal*, colour vision test abnormal† Common Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions’ 1) including dim vision 2) including scotoma 3) including cystoid macular oedema 4) including subretinal fluid 5) events occurring pre-vitrectomy † using the Roth 28-hue colour vision test.

Post-injection monitoring JETREA is administered by intravitreal injection only. Intravitreal injections have been associated with intraocular inflammation/infection, intraocular haemorrhage and increased intraocular pressure (IOP).

Proper aseptic injection techniques must always be used. Following the intravitreal injection, patients should be monitored for any side effects such as (but not limited to) intraocular inflammation/infection and elevation in IOP. Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.

Monitoring for increases in IOP may consist of a check for perfusion of the optic nerve head immediately after the injection and tonometry within 30 minutes following the injection. Intraocular inflammation/infection may be assessed using biomicroscopy between 2 and 7 days following the injection.

Patients should be instructed to report symptoms suggestive of intraocular inflammation/infection or any other visual or ocular symptoms without delay. If any of the above events occur the patient should be treated according to standard medical practice.

Bilateral treatment The safety and efficacy of JETREA administered to both eyes concurrently has not been studied. Therefore administration to both eyes concurrently is not recommended. Repeated administration Repeated administration of JETREA in the same eye has not been adequately studied and is therefore not recommended.

Medicinal product no longer authorised 4 Population with no or limited data JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration (AMD) and vitreous haemorrhage.

1. Active or suspected ocular or periocular infections.