Revakinagene taroretcel

Class
Encapsulated cell-based gene therapy
Subclass
Ciliary neurotrophic factor-producing allogeneic retinal pigment epithelium cells
Substance name
Revakinagene taroretcel, revakinagene taroretcel-lwey
Brand names
Encelto®
Common formulations
Implant
Dosage and administration
Adults patients
Treatment of macular telangiectasia type 2
•
1 implant intravitreal × 1 (200,000-440,000 cells)
Indications for use
Labeled indications
Adults
•
Treatment of macular telangiectasia type 2
Safety risks
Contraindications
Hypersensitivity to endothelial serum-free media
Active or suspected ocular or periocular infection
Warnings and precautions
Cataract
•
Maintain a high level of suspicion, as cataract formation, including cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, and lenticular opacities, has been reported after revakinagene taroretcel implantation.
Delayed dark adaptation
•
Maintain a high level of suspicion, as delayed dark adaptation has occurred after revakinagene taroretcel implantation. Advise patients to take caution while driving and navigating in the dark.
Endophthalmitis
•
Maintain a high level of suspicion, as infectious endophthalmitis may occur after revakinagene taroretcel implantation. Remove the implant if infectious endophthalmitis occurs.
Implant extrusion
•
Maintain a high level of suspicion, as implant extrusion through the initial scleral wound has occurred after revakinagene taroretcel implantation. Evaluate patients after 6 months to confirm proper positioning of the implant and then annually.
Retinal tear, retinal detachment
•
Maintain a high level of suspicion, as retinal tears and retinal detachment may occur after revakinagene taroretcel implantation. Remove the implant if vitrectomy with a complete gas fill or silicone oil fill is required.
Suture-related complications
•
Maintain a high level of suspicion, as suture-related complications, including conjunctival erosions due to suture tips and suture knots, have occurred after revakinagene taroretcel implantation.
Vision loss
•
Maintain a high level of suspicion, as severe vision loss has been reported after revakinagene taroretcel implantation.
Vitreous hemorrhage
•
Maintain a high level of suspicion, as vitreous hemorrhage may occur after revakinagene taroretcel implantation, especially in patients receiving antithrombotic medications such as OACs, aspirin, or NSAIDs. Interrupt antithrombotic therapy before implantation.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence. Evidence of fetal harm in animals.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Conjunctival hyperemia, red eyes, miosis, delayed dark adaptation, eye pain, foreign body sensation in the eyes, subconjunctival hemorrhage, suture-related complications
Common 1-10%
•
Cataract, eye floaters, iridocyclitis, blurred vision, headache, dry eyes, eye discharge, anterior chamber inflammatory cells, eye irritation, itchy eyes, ocular discomfort, vision loss, vitreous hemorrhage
Unknown frequency
•
Endophthalmitis, retinal tear, retinal detachment, implant extrusion
Interactions
Drug(s)
Check Interactions
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