Cenegermin eye prep

Indications

Cenegermin eye prep is used for: Neurotrophic Keratitis

Adult Dose

Neurotrophic Keratitis Indicated for the treatment of neurotrophic keratitis Instill 1 drop in affected eye(s), 6 times a day at 2-hr intervals for 8 weeks

Child Dose

Neurotrophic Keratitis Indicated for the treatment of neurotrophic keratitis Note: Safety and effectiveness have been established in the pediatric population; use in children is supported by evidence from adequate and well-controlled trials in adults with additional safety data in children aged >2 years >2 years: Instill 1 drop in affected eye(s), 6 times a day at 2-hr intervals for 8 weeks

Renal Dose

Administration

Remove single vial from refrigerator in the morning of administration If treatment is started immediately after receiving weekly carton, wait until vial is thawed (may take up to 30 minutes at room temperature up to 77°F [25°C]); do not shake vial Connect vial adapter to vial; attach pipette Draw eye drop solution into pipette; make sure plunger has reached the stop point Air bubbles may cause blockage and prevent pipette from filling properly (especially the first time you withdraw the eye drop solution) Ophthalmic Administration Remove contact lenses before applying; may reinsert 15 minutes after administration If solution missed the eye during administration and there is no solution left in pipette, try again, using a new pipette, wipe, and repeat process Repeat q2hr 6 times a day, using a new sterile disinfectant wipe and a new pipette each time If using drops in both eyes, repeat for other eye using a new pipette; 2 vials will be needed each day

Contra Indications

Precautions

Remove contact lenses before application; the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion Mild-to-moderate eye discomfort (eg, eye pain during treatment); advise patients to contact their doctor if a more serious eye reaction occurs

Pregnancy-Lactation

There are no data from the use in pregnant women to inform any drug-associated risks Animal data Administration of cenegermin to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses In a prenatal and postnatal development study, administration of cenegermin to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Cenegermin eye prep : >10% Eye pain following installation (~16%) 1-10% Corneal deposits Foreign body sensation Ocular hyperemia Ocular inflammation and tearing

Mechanism of Action

Recombinant form of human nerve growth factor produced in Escherichia coli Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (ie, TrkA) and low-affinity (ie, p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity