Important Safety Information
Indications: JETREA® is indicated in adults for
the treatment of vitreomacular traction (VMT), including when associated with macular
hole of diameter less than or equal to 400 microns.
Dosage: JETREA® must be prepared and administered
by a qualified ophthalmologist experienced in intravitreal injections. The recommended
dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection
to the affected eye once as a single dose.
Contraindications: JETREA® is contraindicated for
use with patients who are hypersensitive to ocriplasmin or to any of the excipients
in JETREA® (mannitol, citric acid, sodium hydroxide and water), or
with patients who have active or suspected ocular or periocular infections.
Warnings and Precautions: Post-Injection Monitoring: 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. Other Warnings and Precautions: Administration of JETREA®
to both eyes concurrently has not been studied, and is not recommended. Repeated
administration of JETREA® in the same eye has not been studied, and
is not recommended. There are no clinical data on the concomitant use of ocriplasmin
with VEGF-inhibitors. 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; treatment is not recommended in these patients. The potential for lens
subluxation or phacodonesis cannot be ruled out. There is limited experience in
patients with non-proliferative diabetic retinopathy or in patients with a history
of uveitis or significant eye trauma; caution should be exercised when treating
such patients. The effect of ocriplasmin (particularly in inducing resolution of
vitreomacular adhesion (VMA) or causing total posterior vitreous detachment (PVD)
is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA >1500 microns. Due to a potential increase in tractional forces, there is a risk
of occurrence of new or enlarged macular holes. There is a risk for a significant,
but transient loss of visual acuity during the first week after the injection; patients
should be monitored appropriately.
Interactions: No formal interaction studies have been conducted.
Undesirable Effects: In the JETREA® clinical studies,
all adverse reactions were ocular. Most of the adverse reactions occurred within
the first week after the injection. The majority of these reactions were non-serious,
mild in intensity and resolved within 2 to 3 weeks. The incidence of serious adverse
reactions that occurred in all clinical studies was 2.2% in JETREA®
treated patients and 2.4% in placebo-controlled patients. Very common (≥1/10) adverse
reactions are: vitreous floaters, eye pain, and conjunctival haemorrhage.
Common (≥1/100 to <1/10) adverse reactions are: visual acuity reduced, visual
impairment, vision blurred, retinal haemorrhage, vitreous haemorrhage, retinal tear,
retinal detachment, intraocular pressure increased,macular hole, macular degeneration,
retinal degeneration, macular oedema, retinal oedema, retinal pigment epitheliopathy,
metamorphopsia, vitreous adhesions, conjunctival oedema, eyelid oedema, vitritis,
anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia,
ocular hyperaemia, vitreous detachment, retinogram abnormal, eye irritation, dry
eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia,
and chromatopsia. Uncommon (≥1/1,000 to <1/100) are: transient blindness,
lens subluxation, scotoma, visual field defect, diplopia, hyphaema, miosis, pupils
unequal, corneal abrasion, anterior chamber inflammation, eye inflammation, and
to review the JETREA® Summary of Product Characteristics.