LUXTURNA(voretigene neparvovec-rzyl)intraocular suspension forsubretinal injection(四)
tic bag with syringes containing diluted LUXTURNA into an appropriate secondarycontainer (e.g., hard plastic cooler) for delivery to the surgical suite at room temperature.
2.3 Administration
LUXTURNA should be administered in the surgical suite under controlled aseptic conditions by a surgeonexperienced in performing intraocular surgery. In addition to the syringe containing the diluted LUXTURNA,the following items are required for administration:
• Subretinal injection cannula with a polyamide micro tip with an inner diameter of 41gauge.
• Extension tube made of polyvinyl chloride no longer than 6” (15.2 cm) in length and with an innerdiameter no greater than 1.4mm.
Figure 3. Injection Apparatus AssemblyFollow the steps below for subretinal injection:
1. After confirming the availability of LUXTURNA, dilate the eye and give adequate anesthesia to thepatient.
2. Administer a topical broad spectrum microbiocide to the conjunctiva, cornea and eyelids prior tosurgery.
3. Inspect LUXTURNA prior to administration. If particulates, cloudiness, or discoloration are visible, donot use the product.
4. Connect the syringe containing the diluted LUXTURNA to the extension tube and subretinal injectioncannula. To avoid excess priming volume, the extension tube should not exceed 15.2 cm in length and1.4 mm in inner diameter. Inject the product slowly through the extension tube and the subretinalinjection cannula to eliminate any air bubbles.
5. Confirm the volume of product available in the syringe for injection, by aligning the plunger tip with theline that marks 0.3 mL. (Figure 4)
6Figure 4. Volume of LUXTURNA for Injection
6. After completing a vitrectomy, identify the intended site of administration. The subretinal injectioncannula can be introduced via pars plana. (Figure 5a)
7. Under direct visualization, place the tip of the subretinal injection cannula in contact with the retinalsurface. The recommended site of injection is located along the superior vascular arcade, at least 2 mmdistal to the center of the fovea (Figure 5b), avoiding direct contact with the retinal vasculature or with
areas of pathologic features, such as dense atrophy or intraretinal pigment migration. Inject a smallamount of the product slowly until an initial subretinal bleb is observed. Then inject the remainingvolume slowly until the total 0.3 mL is delivered.
Figure 5a. Subretinal injection cannulaintroduced via pars plana
Figure 5b. Tip of the subretinal injectioncannula placed within the
recommended site of injection(surgeon’s point of view)
8. After completing the injection, remove the subretinal injection cannula from the eye.
9. Following injection, discard all unused product. Dispose of the back-up syringe according to localbiosafety guidelines applicable for handling and disposal of the product.
10. Perform a fluid-air exchange, carefully avoiding fluid drainage near the retinotomy created for thesubretinal injection.
11. Initiate supine head positioning immediately in the post-operative period.
12. Upon discharge, advise patients to rest in a supine position as much as possible for 24 hours.
3 DOSAGE FORMS AND STRENGTHS
LUXTURNA is a suspension for subretinal injection, supplied in a 0.5-mL extractable volume in a 2-mLsingle-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.
4 CONTRAIN |
