Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic [preservative free]:
Oxervate: cenegermin-bkbj 0.002% (1 mL)
Pharmacology
Mechanism of Action
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.
Use: Labeled Indications
Neurotrophic keratitis: Treatment of neurotrophic keratitis
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Neurotrophic keratitis: Instill 1 drop into affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.
Missed dose: If a dose is missed, continue treatment at the next scheduled administration.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Neurotrophic keratitis: Children ≥2 years and Adolescents: Instill 1 drop into the affected eye(s) every 2 hours for 6 doses daily for 8 weeks
Reconstitution
If treatment is initiated immediately after receiving the weekly carton, thaw the first vial (may take up to 30 minutes at room temperature). Attach vial adapter to vial. Clean surface of valve on the connector part of the vial adapter; wait ~1 minute and screw pipette (clockwise) into the connector part of the vial adapter. Invert the vial and gently pull pipette plunger until it stops (to draw the eye drop solution into the pipette). After the pipette has been correctly filled, unscrew pipette (counter-clockwise) from the connector part of the vial adapter.
Administration
Ophthalmic: If more than one topical ophthalmic drug is being used, administer the drugs at least 15 minutes apart; administer cenegermin 15 minutes prior to any eye ointment, gel, or other viscous eye drops. Remove contact lenses prior to administration and wait 15 minutes before reinserting. Pull down lower eyelid and administer into the conjunctival fornix (space between inner eyelid and eyeball). Keep head tilted back and blink a few times so the surface of the eye is covered. Discard pipette immediately after use and use a new pipette for each eye and administration. See manufacturer's labeling for detailed administration.
Storage
Store at -20°C (-4°F). Dispense weekly carton in the insulated pack in the Delivery System Kit. Within 5 hours of leaving the pharmacy, store the weekly carton at 2°C to 8°C (36°F to 46°F) for up to 14 days. Opened vials, including those with the vial adapter connected, may be stored in the original weekly carton in the refrigerator between 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F) for up to 12 hours. Do not refreeze; do not shake vial. Discard any unused portion.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%: Ophthalmic: Eye pain (16%)
1% to 10%:
Central nervous system: Foreign body sensation
Ophthalmic: Corneal deposits, lacrimation, ocular hyperemia, ophthalmic inflammation
Warnings/Precautions
Concerns related to adverse effects:
- Ocular effects: May cause mild to moderate eye discomfort (eg, eye pain); notify health care professional if more serious eye reactions occur.
Special populations:
- Contact lens wearers: Remove contact lenses prior to administration and wait 15 minutes before reinserting.
Pregnancy
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience foreign body sensation in eye, eye redness, or increased tears. Have patient report immediately to prescriber severe eye pain, eye or eyelid swelling, or severe eye irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
