Encelto (revakinagene taroretcel-lwey)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For intravitreal implantation only.

*Revakinagene taroretcel-lwey is intended for surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist.

*The recommended dose is one revakinagene taroretcel-lwey implant per affected eye containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF).

*Carefully inspect revakinagene taroretcel-lwey prior to use and refer to the Instructions for Use when preparing for and performing surgical placement or removal of revakinagene taroretcel-lwey.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Patients with active or suspected ocular or periocular infections.

*Patients with known hypersensitivity to Endothelial Serum Free Media (Endo-SFM).

• Ocular infection

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

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.

There are no severe adverse reactions for this drug.

More Frequent

• Blurred vision
• Cataracts
• Conjunctival hemorrhage
• Conjunctival hyperemia
• Dry eye
• Foreign body sensation of eye
• Headache disorder
• Iridocyclitis
• Miosis
• Ocular discharge
• Ocular discomfort
• Ocular irritation
• Ocular pain
• Vitreous floater
• Vitreous hemorrhage

No enhanced messaging available.

The safety and effectiveness of revakinagene taroretcel-lwey have not been established in pediatric patients.

There are no data on the use of revakinagene taroretcel-lwey in pregnant women. Endogenous ciliary neurotrophic factor is naturally found in maternal plasma, placental cells, and umbilical cord blood. It is not known if the use of revakinagene taroretcel-lwey increases CNTF above naturally occurring levels in these tissues.

In animal reproduction studies, subcutaneous administration of rhCNTF to pregnant rats and rabbits demonstrated no evidence of teratogenic effects on the fetus. However, when administered to rabbits at a dose level of 10ug/kg/day, a decrease in implantations and live fetuses was observed. When administered to rats at a dose level of 100 ug/kg/day a decrease in corpora lutea was observed.

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

There is no data on the presence of revakinagene taroretcel-lwey in human milk, its effects on the breastfed infant, or its impact on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for revakinagene taroretcel-lwey and any potential adverse effects on the breastfed infant from rhCNTF or from the underlying maternal condition.

There were 38 patients (32%) 65 years of age and older and two patients (1%) 75 years of age and older in Study 1 and Study 2 who received revakinagene taroretcel-lwey. Clinical studies of revakinagene taroretcel-lwey did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger patients.