Safety profile
Warnings and precautions
Endophthalmitis1
Endophthalmitis may occur following any intraocular surgical procedure or injection. Use proper aseptic injection technique when administering LUXTURNA®. Following the injection, monitor patients to permit early treatment of any infection. Advise patients to report any signs or symptoms of infection or inflammation without delay.
Permanent decline in visual acuity1
Permanent decline in visual acuity may occur following subretinal injection of LUXTURNA. Monitor patients for visual disturbances.
Retinal abnormalities1
Retinal abnormalities may occur during or following the subretinal injection of LUXTURNA, including macular holes, foveal thinning, loss of foveal function, foveal dehiscence, chorioretinal atrophy, and retinal hemorrhage. Monitor and manage these retinal abnormalities appropriately. Do not administer LUXTURNA in the immediate vicinity of the fovea.
Retinal abnormalities may occur during or following vitrectomy including retinal tears, epiretinal membrane, or retinal detachment. Monitor patients during and following the injection to permit early treatment of these retinal abnormalities. Advise patients to report any signs or symptoms of retinal tears and/or detachment without delay.
Increased intraocular pressure1
Increased intraocular pressure may occur after subretinal injection of LUXTURNA. Monitor and manage intraocular pressure appropriately.
Expansion of intraocular air bubbles1
Instruct patients to avoid air travel, travel to high elevations, or scuba diving until the air bubble formed following administration of LUXTURNA has completely dissipated from the eye. It may take one week or more following injection for the air bubble to dissipate. A change in altitude while the air bubble is still present can result in irreversible vision loss. Verify the dissipation of the air bubble through ophthalmic examination.
Cataract1
Subretinal injection of LUXTURNA, especially vitrectomy surgery, is associated with an increased incidence of cataract development and/or progression.
Adverse reactions1
The most common adverse reactions (incidence ≥5%) were conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen (thinning of the corneal stroma), macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain, and maculopathy (wrinkling on the surface of the macula).
Ocular adverse reactions following treatment with LUXTURNA1
| ADVERSE REACTIONS | SUBJECTS (n=41) | TREATED EYES (n=81) |
|---|---|---|
| Any ocular adverse reaction | 27 (66%) | 46 (57%) |
| Conjunctival hyperemia | 9 (22%) | 9 (11%) |
| Cataract | 8 (20%) | 15 (19%) |
| Increased intraocular pressure | 6 (15%) | 8 (10%) |
| Retinal tear | 4 (10%) | 4 (5%) |
| Dellen (thinning of the corneal stroma) | 3 (7%) | 3 (4%) |
| Macular hole | 3 (7%) | 3 (4%) |
| Subretinal deposits* | 3 (7%) | 3 (4%) |
| Eye inflammation | 2 (5%) | 4 (5%) |
| Eye irritation | 2 (5%) | 2 (2%) |
| Eye pain | 2 (5%) | 2 (2%) |
| Maculopathy (wrinkling on the surface of the macula) | 2 (5%) | 3 (4%) |
| Foveal thinning and loss of foveal function | 1 (2%) | 2 (2%) |
| Endophthalmitis | 1 (2%) | 1 (1%) |
| Foveal dehiscence (separation of the retinal layers in the center of the macula) | 1 (2%) | 1 (1%) |
| Retinal hemorrhage | 1 (2%) | 1 (1%) |
*Transient appearance of asymptomatic subretinal precipitates inferior to the retinal injection site 1-6 days after injection.
The safety of LUXTURNA is monitored with an ongoing safety registry for treated patients2
