Revakinagene taroretcel

Revakinagene taroretcel is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

• Revakinagene taroretcel is available under the following different brand names: Encelto, revakinagene taroretcel-lwey.

Common side effects of Revakinagene taroretcel include:

• delayed dark adaptation 
• foreign body sensation 
• eye pain 
• miosis
• conjunctival hyperemia 
• eye pruritus
• ocular discomfort
• vitreous hemorrhage  
• blurred vision 
• headache 
• dry eye
• eye irritation
• vitreous floaters
• eye discharge
• anterior chamber cell 
• iridocyclitis

Serious side effects of Revakinagene taroretcel include:

• severe vision loss
• cataract progression
• suture-related complications
• conjunctival hemorrhage 

Rare side effects of Revakinagene taroretcel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravitreal implant

• 200,000-440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotropic factor (rhCNTF)

Macular telangiectasia type 2

Adult dosage

• 1 implant per affected eye
• Surgical intravitreal implantation is performed under aseptic conditions by a qualified ophthalmologist

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Revakinagene taroretcel has no noted severe interactions with any other drugs
• Revakinagene taroretcel has no noted serious interactions with any other drugs
• Revakinagene taroretcel has no noted moderate interactions with any other drugs
• Revakinagene taroretcel has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Ocular or periocular infections
• Known hypersensitivity to endothelial serum-free media (Endo-SFM)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Revakinagene taroretcel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Revakinagene taroretcel?”

Cautions

Severe vision loss

• Severe vision loss is defined as 3 lines or more of visual acuity loss (15 or more early treatment diabetic retinopathy study [ETDRS] letters) reported following implantation
• Monitor patients for signs and symptoms of vision loss and manage as clinically indicated

Infectious endophthalmitis

• Infectious endophthalmitis may occur
• Signs and symptoms include progressively worsening eye pain, vision loss, or scleral and conjunctival injection
• Mitigate risk by using a proper aseptic surgical technique
• Monitor for signs or symptoms of infectious endophthalmitis
• Remove implant if infectious endophthalmitis occurs and manage symptoms according to clinical practice

Retinal tear and detachment

• Retinal tears and detachment may occur
• Signs and symptoms of retinal tears include acute onset of flashing lights, floaters, and/or loss of visual acuity
• Signs and symptoms of retinal detachment may include progressive visual field loss and/or loss of visual acuity
• Use standard vitreoretinal surgical techniques during implantation to minimize risk
• Monitor for any signs or symptoms; treat rhegmatogenous retinal detachment and retinal tears promptly
• Remove the implant if vitrectomy with complete gas fill or silicone oil fill is required

Vitreous hemorrhage

• Vitreous hemorrhage, which may result in temporary vision loss, has occurred
• Interrupt antithrombotic medication (e.g., oral anticoagulants, aspirin, NSAIDs) before Revakinagene taroretcel insertion surgery to reduce the risk of implantation-related vitreous hemorrhage
• Vitrectomy surgery may be necessary to clear severe, recurrent, or non-clearing vitreous hemorrhage
• Vitreous hemorrhages occurring after 1 year from implantation may signal implant extrusion; examine the surgical site closely and surgically reposition the implant if indicated

Implant extrusion

• Implant extrusion through the initial scleral wound has occurred
• Signs and symptoms include recurrent uveitis, vitreous hemorrhage, eye pain lasting more than 1 year after implantation, or visibility of the titanium fixation loop under the conjunctiva
• Reduce the risk of implant extrusion, carefully follow specific surgical steps for implantation
• Evaluate patients after 6 months to confirm proper positioning and then annually
• If the implant begins to extrude, surgically reposition it to the proper scleral wound depth either in the same site or in the opposing inferior quadrant of the vitreous cavity

Cataract formation

• Cataract formation (e.g., cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, lenticular opacities) reported
• Reduce the risk of formation or progression by carefully following specific surgical steps for implantation

Suture related complications

• Suture-related complications (e.g., conjunctival erosions owing to suture tips and suture knots) can occur following implantation
• Mitigate risk by carefully following specific surgical steps and managing suture-related complications as clinically indicated

Delayed dark adaptation

• Delayed ability to adjust vision from bright lighting conditions to dim lighting was reported; this remained unchanged for the duration of the study follow-up
• Advise patients to take caution while driving and navigating in dark conditions
• Advise caution when moving from bright to dark areas, such as entering a dark room or stepping outside at dusk; consider using flashlights, nightlights, or motion-activated lighting at home
• Consider wearing sunglasses or tinted lenses in bright environments to reduce the impact of transitioning from light to dark

Pregnancy and Lactation

• There is no data regarding the drug’s use during pregnancy
• Endogenous CNTF is naturally found in maternal plasma, placental cells, and umbilical cord blood; unknown if use increases CNTF above naturally occurring levels in these tissues

Lactation

• Data are unavailable regarding the presence of  revakinagene taroretcel in human milk, its effects on breastfed infants, or its impact on milk production