Luxturna (voretigene neparvovec-rzyl)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For subretinal injection only.

*Perform subretinal administration of voretigene neparvovec-rzyl to each eye on separate days within a close interval, but no fewer than 6 days apart.

*The manufacturer recommends administration of 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 voretigene neparvovec-rzyl to each eye), followed by a tapering dose during the next 10 days. The same corticosteroid dosing regimen applies for the administration of voretigene neparvovec-rzyl to the second eye. If the corticosteroid taper following voretigene neparvovec-rzyl administration to the first eye is not complete three days prior to the planned voretigene neparvovec-rzyl administration to the second eye, then the corticosteroid regimen for the second eye replaces the taper for the first eye.

*Dilute voretigene neparvovec-rzyl with the supplied Diluent prior to use. Prepare voretigene neparvovec-rzyl within 4 hours of administration using sterile technique under aseptic conditions in a Class II vertical laminar flow biological safety cabinet (BSC).

*Voretigene neparvovec-rzyl should be administered in the surgical suite under controlled aseptic conditions by a surgeon experienced in performing intraocular surgery.

* For additional details on preparation and administration, consult the Full Prescribing Information.

The recommended dose of voretigene neparvovec-rzyl for each eye is 1.5 x 1011 vg, administered by subretinal injection in a total volume of 0.3 mL. Use in pediatric patients younger than 12 months of age is not recommended because of potential dilution or loss of voretigene neparvovec-rzyl after administration due to the active retinal cell proliferation occurring in this age group.

The recommended dose of voretigene neparvovec-rzyl for each eye is 1.5 x 1011 vg, administered by subretinal injection in a total volume of 0.3 mL.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions (incidence >= 5%) in the clinical trials 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).

More Frequent

• Cataracts
• Corneal dystrophy
• Macular hole
• Ocular hypertension
• Retinal tear

Less Frequent

• Endophthalmitis

Rare or Very Rare

• Chorioretinal atrophy
• Retinal depigmentation
• Retinal hemorrhage

More Frequent

• Conjunctival hyperemia
• Maculopathy
• Ocular inflammation
• Ocular irritation
• Ocular pain

No enhanced messaging available.

Treatment with voretigene neparvovec-rzyl is not recommended for patients younger than 12 months of age, because the retinal cells are still undergoing cell proliferation, and voretigene neparvovec-rzyl would potentially be diluted or lost during cell proliferation.

The safety and efficacy of voretigene neparvovec-rzyl have been established in pediatric patients. Use of voretigene neparvovec-rzyl is supported by a phase 1 study and a phase 3 study that included a total of 25 pediatric patients with biallelic RPE65 mutation-associated retinal dystrophy in the following age groups: 21 children (4 years to less than 12 years of age) and 4 adolescents (12 years to less than 17 years of age). There were no significant differences in safety between the different age subgroups.

Adequate and well-controlled studies with voretigene neparvovec-rzyl have not been conducted in pregnant women. Animal reproductive studies have not been conducted with voretigene neparvovec-rzyl. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There is no information regarding the presence of voretigene neparvovec-rzyl in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voretigene neparvovec-rzyl and any potential adverse effects on the breastfed infant from voretigene neparvovec-rzyl.

The safety and effectiveness of voretigene neparvovec-rzyl have not been established in geriatric patients. Clinical studies of voretigene neparvovec-rzyl for this indication did not include patients 65 years of age and older.