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Luxturna

Last reviewed on RxList: 7/20/2020
Luxturna Side Effects Center

What Is Luxturna?

Luxturna (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65mutation-associated retinal dystrophy.

What Are Side Effects of Luxturna?

Common side effects include:

Dosage for Luxturna

The recommended dose of Luxturna for each eye is 1.5 x 10 vector 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.

What Drugs, Substances, or Supplements Interact with Luxturna?

Luxturna may interact with other drugs. Tell your doctor all medications and supplements you use.

Luxturna During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Luxturna; it is unknown if it would affect a fetus. It is unknown if Luxturna passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Luxturna (voretigene neparvovec-rzyl) Intraocular Suspension for Subretinal Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Luxturna Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Voretigene neparvovec can cause changes in your retina that could lead to vision loss, including:

  • new or worsening cataract (clouding of the lens inside of the eye);
  • thinning of the clear layer in front of your eye;
  • deposits under your retina;
  • separating layers or a developing hole in the center of your retina;
  • thinning of the retina or loss of function;
  • breaks or wrinkling on the surface of your retina;
  • retinal detachment;
  • bleeding in the retina; or
  • permanent decline in the sharpness of your vision.

Talk to your doctor about the risks and benefits of this medicine.

Call your doctor at once if you have:

  • new or worsening vision problems;
  • eye pain;
  • flashes of light or "floaters" in your vision, seeing halos around lights; or
  • signs of eye infection--eye pain or swelling, headache, increased sensitivity to light, crusting or drainage, vision loss.

Common side effects may include:

  • eye pain, swelling, or redness;
  • cataract (cloudy appearance in the eye);
  • swelling of the eyelids; or
  • increased pressure inside the eye.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Luxturna (Voretigene Neparvovec-rzyl Intraocular Suspension for Injection)

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Luxturna Professional Information

SIDE EFFECTS

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).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other products and may not reflect the rates observed in practice.

The safety data described in this section reflect exposure to LUXTURNA in two clinical trials consisting of 41 subjects (81 eyes) with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Forty of the 41 subjects 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 an open-label, dose-exploration safety study. Study 2 (n=29) was an open-label, randomized, controlled study for both efficacy and safety [see Clinical Studies]. The average age of the 41 subjects was 17 years ranging from 4 to 44 years. Of the 41 subjects, 25 (61%) were pediatric subjects under 18 years of age, and 23 (56%) were females.

Twenty-seven (27/41, 66%) subjects had ocular adverse reactions that involved 46 injected eyes (46/81, 57%). Adverse reactions among all subjects in Studies 1 and 2 are described in Table 1. Adverse reactions may have been related to voretigene neparvovec-rzyl, the subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products.

Table 1: Ocular Adverse Reactions Following Treatment with LUXTURNA (N=41)

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

Immunogenicity

At all doses of LUXTURNA evaluated in Studies 1 and 2, immune reactions and extra-ocular exposure were mild. In Study 1 (n=12), the interval between the subretinal injections into the two eyes ranged from 1.7 to 4.6 years. In Study 2, the interval between the subretinal injections into the two eyes ranged from 7 to 14 days. No subject had a clinically significant cytotoxic T-cell response to either AAV2 or RPE65.

Subjects received systemic corticosteroids before and after subretinal injection of LUXTURNA to each eye. The corticosteroids may have decreased the potential immune reaction to either vector capsid (adeno-associated virus serotype 2 [AAV2] vector) or transgene product (retinal pigment epithelial 65 kDa protein [RPE65]).

Read the entire FDA prescribing information for Luxturna (Voretigene Neparvovec-rzyl Intraocular Suspension for Injection)

Related Resources for Luxturna

© Luxturna Patient Information is supplied by Cerner Multum, Inc. and Luxturna Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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