Luxturna

LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic

Patients must have viable retinal cells as determined by the treating physician(s).

• The recommended dose of LUXTURNA for each eye is 1.5 x 10¹¹ vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL.
  2.1 Dose

  • The recommended dose of LUXTURNA for each eye is 1.5 x 10¹¹vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL.
  • Perform subretinal administration of LUXTURNA to each eye on separate days within a close interval, but no fewer than 6 days apart.
  • Recommend systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of LUXTURNA to the first eye), and followed by tapering the dose during the following 10 days. The same corticosteroid dosing regimen applies for the administration of LUXTURNA to the second eye. If the corticosteroid taper following LUXTURNA administration to the first eye is not complete three days prior to the planned LUXTURNA administration to the second eye, then the corticosteroid regimen for the second eye replaces the taper for the first eye.
  )
• Perform subretinal administration of LUXTURNA to each eye on separate days within a close interval, but no fewer than 6 days apart. (
  2.1 Dose

  • The recommended dose of LUXTURNA for each eye is 1.5 x 10¹¹vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL.
  • Perform subretinal administration of LUXTURNA to each eye on separate days within a close interval, but no fewer than 6 days apart.
  • Recommend systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of LUXTURNA to the first eye), and followed by tapering the dose during the following 10 days. The same corticosteroid dosing regimen applies for the administration of LUXTURNA to the second eye. If the corticosteroid taper following LUXTURNA administration to the first eye is not complete three days prior to the planned LUXTURNA administration to the second eye, then the corticosteroid regimen for the second eye replaces the taper for the first eye.
  )
• Recommend systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of LUXTURNA to each eye), and followed by a tapering dose during the next 10 days. (
  2.1 Dose

  • The recommended dose of LUXTURNA for each eye is 1.5 x 10¹¹vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL.
  • Perform subretinal administration of LUXTURNA to each eye on separate days within a close interval, but no fewer than 6 days apart.
  • Recommend systemic oral corticosteroids equivalent to prednisone at 1 mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of LUXTURNA to the first eye), and followed by tapering the dose during the following 10 days. The same corticosteroid dosing regimen applies for the administration of LUXTURNA to the second eye. If the corticosteroid taper following LUXTURNA administration to the first eye is not complete three days prior to the planned LUXTURNA administration to the second eye, then the corticosteroid regimen for the second eye replaces the taper for the first eye.
  )

LUXTURNA is a suspension for subretinal injection, supplied in a 0.5-mL extractable volume in a 2-mL single-dose vial; the supplied concentration (5 x 10¹² vg/mL) requires a 1:10 dilution prior to administration. The Diluent is supplied in two single-use 2 mL vials.

Pediatric use: Use in infants under 12 months of age is not recommended because of potential dilution or loss of LUXTURNA after administration due to the active retinal cell proliferation occurring in this age group. (

• Endophthalmitis: Use proper aseptic injection technique and monitor for signs and symptoms of infection. (
  5.1 Endophthalmitis

  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 acuity: Monitor for visual disturbances. (
  5.2 Permanent Decline in Visual Acuity

  Permanent decline in visual acuity may occur following subretinal injection of LUXTURNA. Monitor patients for visual disturbances.
  )
• Retinal abnormalities: Monitor for macular abnormalities, retinal tears or breaks and chorioretinal atrophy. Do not inject in the immediate vicinity of the fovea. (
  5.3 Retinal Abnormalities

  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 [

  see Dosage and Administration

  ].

  
  
  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 pressure: Monitor and manage intraocular pressure elevations. (
  5.4 Increased Intraocular Pressure

  Increased intraocular pressure may occur after subretinal injection of LUXTURNA. Monitor and manage intraocular pressure appropriately.
  )
• Expansion of intraocular air bubbles: Air travel and/or scuba diving is not recommended until any intraocular air bubbles have been absorbed. (
  5.5 Expansion of Intraocular Air Bubbles

  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.
  )
• Cataract: Subretinal injection of LUXTURNA may result in cataract formation or increase in the rate of cataract progression. (
  5.6 Cataract

  Subretinal injection of LUXTURNA, especially vitrectomy surgery, is associated with an increased incidence of cataract development and/or progression.
  )