Netalo

Dosage Form & Strength

The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended.

Indications

Netalo is indicated for the treatment of Open-angle glaucoma, Ocular hypertension, Normal Tension glaucoma & Steroid-induced glaucoma

Adverse Effects

The most common adverse reaction is conjunctival hyperemia (53%). Other common adverse reactions, approximately 20% include: corneal verticillata, instillation site pain, and conjunctival hemorrhage

Mechanism of Action

Netarsudil is a rho kinase inhibitor, which is believed to reduce IOP by increasing the outflow of aqueous humor through the trabecular meshwork route.

Pharmacokinetics

No quantifiable plasma concentrations of Netarsudil post dose on Day 1 and Day 8 is seen, so the half life of Netarsudil in Netalo is negligible

Absorption, Distribution, Metabolism & Excretion

Absorption There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only one plasma concentration at 0.11 ng/mL for the active metabolite was observed for one subject on Day 8 at 8 hours post-dose. Metabolism After topical ocular dosing, netarsudil is metabolized by esterases in the eye.

Drug Use in Pregnancy

Pregnancy: Risk Summary: There are no available data on Netalo use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low. Lactation: There are no data on the presence of Netalo in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to netarsudil following topical ocular administration is low, and it is not known whether measurable levels of netarsudil would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Netalo and any potential adverse effects on the breast-fed child from Netalo.