Revakinagene Taroretcel-lwey
Generic Name: revakinagene taroretcel-lwey
Brand Names:
Encelto
11 DESCRIPTION ENCELTO (revakinagene taroretcel-lwey) implant, is single-dose, sterile, nonpyrogenic and retrievable. ENCELTO is an allogeneic encapsulated cell-based gene therapy that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line) for surgical intravitreal placement.
Overview
11 DESCRIPTION ENCELTO (revakinagene taroretcel-lwey) implant, is single-dose, sterile, nonpyrogenic and retrievable. ENCELTO is an allogeneic encapsulated cell-based gene therapy that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line) for surgical intravitreal placement.
Uses
1 INDICATIONS AND USAGE ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
Dosage
2 DOSAGE AND ADMINISTRATION For intravitreal implantation only. ENCELTO is intended for surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist. ( 2.1 ) The recommended dose is one ENCELTO implant per affected eye containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF). ( 2.1 ) Carefully inspect ENCELTO prior to use and refer to the Instructions for Use when preparing for and performing surgical placement or removal of ENCELTO. ( 2.2 , 2.3 ) 2.1 Recommended Dose For intravitreal implantation only • ENCELTO is administered by a single surgical intravitreal procedure performed by a qualified ophthalmologist. • The recommended dose is one ENCELTO implant per affected eye.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, iridocyclitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurotech at 1- 833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
5 WARNINGS AND PRECAUTIONS ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, and delayed dark adaptation. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ) Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to ENCELTO insertion surgery to reduce the risk of implantation related vitreous hemorrhage. Vitreous hemorrhages occurring greater than one year from implantation could be a sign of ENCELTO extrusion. 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 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ENCELTO is supplied as a sterile, single-dose, implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF (NTC-201-6A cell line). ENCELTO is packaged in a protective inner container within an Endothelial Serum Free Media (Endo-SFM), which is maintained sterile by a sealed outer container.
Frequently Asked Questions
What is Revakinagene Taroretcel-lwey used for?▼
1 INDICATIONS AND USAGE ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
What are the side effects of Revakinagene Taroretcel-lwey?▼
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, iridocyclitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurotech at 1- 833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
What are the important warnings for Revakinagene Taroretcel-lwey?▼
5 WARNINGS AND PRECAUTIONS ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, and delayed dark adaptation. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ) Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to ENCELTO insertion surgery to reduce the risk of implantation related vitreous hemorrhage. Vitreous hemorrhages occurring greater than one year from implantation could be a sign of ENCELTO extrusion. 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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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.