LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection(一)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LUXTURNA safely and effectively. See full prescribing information for
LUXTURNA.
LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
LUXTURNA is an adeno-associated virus vector-based gene therapyindicated for the treatment of patients with confirmed biallelic RPE65mutation-associated retinal dystrophy. Patients must have viable retinal cellsas determined by the treating physician(s). (1)
DOSAGE AND ADMINISTRATION
For subretinal injection only.
• The recommended dose of LUXTURNA for each eye is 1.5 x 1011vector genomes (vg), administered by subretinal injection in a totalvolume of 0.3 mL. (2.1)
• Perform subretinal administration of LUXTURNA to each eye onseparate days within a close interval, but no fewer than 6 days apart.(2.1)
• Recommend systemic oral corticosteroids equivalent to prednisone at 1mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3days before administration of LUXTURNA to each eye), and followedby a tapering dose during the next 10 days. (2.1)
DOSAGE FORMS AND STRENGTHS
LUXTURNA is a suspension for subretinal injection, supplied in a 0.5 mLextractable volume in a single-dose 2 mL vial for a single administration in oneeye. The supplied concentration (5x1012vg/mL) requires a 1:10 dilution prior toadministration. The Diluent is supplied in two single-use 2-mL vials. (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
• Endophthalmitis: Use proper aseptic injection technique and monitor forsigns and symptoms of infection. (5.1)
• Permanent decline in visual acuity: Monitor for visual disturbances.(5.2)
• Retinal abnormalities: Monitor for macular abnormalities, retinal tears orbreaks. Do not inject in the immediate vicinity of the fovea. (5.3)
• Increased intraocular pressure: Monitor and manage intraocular pressureelevations. (5.4)
• Expansion of intraocular air bubbles: Air travel and/or scuba diving isnot recommended until any intraocular air bubbles have been absorbed.(5.5)
• Cataract: Subretinal injection of LUXTURNA may result in cataractformation or increase in the rate of cataract progression. (5.6)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) in the clinical trialswere conjunctival hyperemia, cataract, increased intraocular pressure, retinaltear, dellen (thinning of the corneal stroma), macular hole, subretinal deposits,eye inflammation, eye irritation, eye pain, and maculopathy (wrinkling on thesurface of the macula). (6)
To report SUSPECTED ADVERSE REACTIONS, contact SparkTherapeutics, Inc. at 1-855-SPARKTX, or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric use: Use in infants under 12 months of age is not recommendedbecause of potential dilution or loss of LUXTURNA after administration dueto the active retinal cells proliferation occurring in this age group. (8.4)
See 17 for PATIENT COUNSELING INFORMATION
------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Preparation
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Endop |
