ENCELTO (revakinagene taroretcel-lwey)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Ocular infection

There are 0 severe contraindications.

There are 0 moderate contraindications.

There are 0 severe adverse reactions.

There are 15 less severe adverse reactions.

More Frequent	Less 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	None.

Rare/Very Rare
None.

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.