LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection(五)
DICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis
Endophthalmitis may occur following any intraocular surgical procedure or injection. Use proper asepticinjection technique when administering LUXTURNA. Following the injection, monitor patients to permit earlytreatment of any infection. Advise patients to report any signs or symptoms of infection or inflammationwithout delay.
5.2 Permanent decline in visual acuity
Permanent decline in visual acuity may occur following subretinal injection of LUXTURNA. Monitor patientsfor visual disturbances.
5.3 Retinal abnormalities
Retinal abnormalities may occur during or following the subretinal injection of LUXTURNA, includingmacular holes, foveal thinning, loss of foveal function, foveal dehiscence, and retinal hemorrhage. Monitor andmanage these retinal abnormalities appropriately. Do not administer LUXTURNA in the immediate vicinity ofthe fovea. [see Dosage and Administration (2.3)]
Retinal abnormalities may occur during or following vitrectomy including retinal tears, epiretinal membrane, orretinal detachment. Monitor patients during and following the injection to permit early treatment of these retinalabnormalities. Advise patients to report any signs or symptoms of retinal tears and/or detachment without delay.
5.4 Increased intraocular pressure
Increased intraocular pressure may occur after subretinal injection of LUXTURNA. Monitor and manage
intraocular pressure appropriately.
5.5 Expansion of intraocular air bubbles
Instruct patients to avoid air travel, travel to high elevations or scuba diving until the air bubble formedfollowing administration of LUXTURNA has completely dissipated from the eye. It may take one week ormore 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.
5.6 Cataract
Subretinal injection of LUXTURNA, especially vitrectomy surgery, is associated with an increased incidence ofcataract development and/or progression.
6 ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) were conjunctival hyperemia, cataract, increasedintraocular pressure, retinal tear, dellen (thinning of the corneal stroma), macular hole, subretinal deposits, eyeinflammation, eye irritation, eye pain, and maculopathy (wrinkling on the surface of the macula).
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of other products and may notreflect the rates observed in practice.
The safety data described in this section reflect exposure to LUXTURNA in two clinical trials consisting of 41subjects (81 eyes) with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Forty of the 41subjects received sequential subretinal injections of LUXTURNA to each eye. One subject received
LUXTURNA in only one eye. Seventy-two of the 81 eyes were exposed to the recommended dose of
LUXTURNA at 1.5 x 1011 vg; 9 eyes were exposed to lower doses of LUXTURNA. Study 1 (n=12) was anopen-label, dose-exploration safety study. Study 2 (n=29) was an open-label, randomized, controlled study forboth efficacy and safety [(see Clinical Studies (14)]. The average age of the 41 s |
