Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.002% (20 mcg/mL)
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
Also see Administration
Dosing Considerations
Remove contact lenses before applying; may be reinserted 15 minutes after administration
Dosage Forms & Strengths
ophthalmic solution
- 0.002% (20 mcg/mL)
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
Also see Administration
Dosing Considerations
Remove contact lenses before applying; may be reinserted 15 minutes after administration
Adverse Effects
>10%
Eye pain following installation (~16%)
1-10%
Corneal deposits
Foreign body sensation
Ocular hyperemia
Ocular inflammation and tearing
Postmarketing Reports
Eye disorders: Eye irritation, blepharitis (including eyelid margin crusting and eyelid edema) and corneal neovascularization
Warnings
Contraindications
None
Cautions
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
Pregnancy
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
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
Pharmacokinetics
No pharmacokinetic studies have been conducted in humans
Extent of systemic exposure to cenegermin following topical ophthalmic administration is not known
Administration
Ophthalmic Preparation
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)
Also see Storage
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
Discard used vial at the end of each day, even if there is still some remaining solution left
Record time of administration on the weekly dose-recording card provided with delivery system
If more than 1 topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart
Missed dose
- If a dose is missed, continue treatment as normal, at next scheduled administration
Storage
Prior to dispensing from the pharmacy
- Store weekly carton in the freezer at or below -4°F (-20°C); dispense in insulated pack in delivery system kit
Following dispensing from the pharmacy
- Within 5 hr of leaving the pharmacy, refrigerate carton between 36-46°F (2-8°C) for up to 14 days
Opened vials
- Refrigerate between 36-46°F (2-8°C) or at room temperature up to 77°F (25°C), for up to 12 hr
- Do not refreeze; do not shake vial
- Discard any unused portion after 12 hr
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
