Revakinagene taroretcel
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
| Surgical Steps | |
| 1. Preparing the Surgical Site (Figure 11) a. Create a 7x7 mm peritomy of the conjunctiva and Tenon’s capsule to expose the insertion site. b. Place a corneal-limbal traction suture in the quadrant where ENCELTO is located. c. Maintain hemostasis of the sclera and surrounding conjunctiva. | |
| 2. Establishing Infusion & Vitrectomy (Figure 12) a. Place an infusion cannula in the inferior quadrant (opposite ENCELTO). b. Confirm the infusion line is positioned within the vitreous cavity before opening the infusion. c. Insert two superior cannulas following normal pars plana vitrectomy protocol. d. Perform a thorough vitrectomy to remove vitreous surrounding ENCELTO without disrupting the hollow fiber membrane. | |
| 3. Reopening the Sclerotomy a. Locate the ENCELTO incision and remove the two nylon sutures while leaving the polypropylene suture intact (Figure 13). b. Using an MVR blade, carefully dissect open the original scleral incision down to the ENCELTO cap at the base of the fixation loop (Figure 14). c. Extend the incision along the entire 3.0 mm length to full thickness. d. Cut the polypropylene anchor suture on the anterior side of the knot. e. Turn off or lower infusion pressure. | |
| 4. Removing ENCELTO (Figure 15) a. Fully open the pars plana sclerotomy and confirm there is no spanning uveal tissue. b. Identify and grasp the fixation loop. c. Cut off the remaining polypropylene knot. d. Remove ENCELTO from the eye. e. Inspect the ENCELTO capsule for any damage or penetration. f. Do not discard or dispose of the ENCELTO implant. Call and report to 1-833-963-9275. The appropriate action will be taken to initiate the return of ENCELTO and possible replacement. | |
| 5. Closing the Incision a. Remove any prolapsed vitreous. b. Close the sclerotomy with interrupted 7-0 Vicryl sutures for a watertight closure. c. Remove the infusion line and additional cannulas. d. Close the conjunctiva with 6-0 plain gut sutures or equivalent. | |
| Post-Operative Wound CareThe patient is to use:A topical antibiotic solution at a frequency of 1 drop four times a day for 7 days.A steroid drop taper of prednisolone acetate 1% (or equivalent) starting the day after surgery with the following taper:1 drop four times a day for the first 7 days;1 drop three times a day for the next 7 days;1 drop two times a day for the next 7 days;1 drop once a day for the last 7 days. | |
Contraindications
4 CONTRAINDICATIONS ENCELTO is contraindicated in patients with: Active or suspected ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Ocular or periocular infections. ( 4 ) Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM). ( 4 )
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Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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