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Cenegermin-bkbj (EENT) (Monograph)

Brand name: Oxervate
Drug class: Anti-inflammatory Agents

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Recombinant form of human nerve growth factor.

Uses for Cenegermin-bkbj (EENT)

Neurotrophic Keratitis

Topical treatment of neurotrophic keratitis (designated an orphan drug by FDA for this use ).

Neurotrophic keratitis is a rare degenerative corneal disease caused by trigeminal nerve damage resulting in partial or total loss of corneal sensation. Loss of corneal sensory innervation reduces protective (e.g., lacrimation) reflexes and alters levels of trophic neuromodulators that support corneal epithelial cell homeostasis, leading to impaired corneal wound healing and progressive ocular surface changes (ranging up to stromal melting and corneal perforation).

Cenegermin-bkbj (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.002% ophthalmic solution topically to the affected eye(s).

For topical ophthalmic use only.

Remove contact lenses prior to administration; wait ≥15 minutes after administration before reinserting contact lenses.

Instill ophthalmic solution 15 minutes before any other ophthalmic ointment, gel, or other viscous drops. If more than one topical ophthalmic drug used, administer the drugs at least 15 minutes apart to avoid diluting the preparations.

Blink several times after administering each dose to ensure that the drug covers the surface of the eye.

If a dose is missed, resume usual administration schedule with the next scheduled dose. Do not administer an extra dose to make up for a missed dose.

Assembly and Use of Kit Components

Available in a kit containing a carton of seven 1-mL multiple-dose vials of the drug in an insulated package, 8 vial adapters, 45 pipettes and sterile disinfectant wipes, and a card for recording administration. (See Storage under Stability.)

Do not shake the vials.

Prepare only the number of vials required for use during a single day (1 vial for treatment of one eye, 2 vials for treatment of both eyes).

When initiating treatment immediately after receiving the drug from a pharmacy, allow first vial to thaw at room temperature up to 25°C (may take up to 30 minutes) prior to preparation for use.

Pierce vial stopper with an adapter from the kit. Do not remove vial adapter following connection to the vial.

Prior to removing a dose from the vial, clean the adapter with a disinfectant wipe and then screw a pipette into the adapter.

Once pipette is properly filled, disconnect it from the adapter and administer the dose directly from the pipette into the conjunctival fornix.

Withdraw each dose just prior to administration with a new pipette for each application in each eye. If the drop misses the eye during administration and no ophthalmic solution remains in the pipette, use a new pipette to withdraw and administer dose.

Consult manufacturer's instructions for detailed information regarding preparation and ocular administration.

Dosage

Pediatric Patients

Neurotrophic Keratitis
Ophthalmic

Children ≥2 years of age: Instill 1 drop in the affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.

Adults

Neurotrophic Keratitis
Ophthalmic

Instill 1 drop in the affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.

Special Populations

No special population dosage recommendations at this time.

Cautions for Cenegermin-bkbj (EENT)

Contraindications

Warnings/Precautions

Warnings and Precautions

Use with Contact Lenses

Remove contact lenses prior to administration; may be reinserted 15 minutes following administration.

Presence of contact lens could limit distribution of the drug onto the area of the corneal lesion.

Eye Discomfort

May cause mild to moderate eye discomfort (e.g., eye pain).

Specific Populations

Pregnancy

Data not available regarding use in pregnant women.

In animal studies, no adverse effects on the fetus or offspring were observed.

Lactation

Not known whether cenegermin distributes into milk following topical application to the eye, affects breast-fed infants, or affects milk production.

Consider benefits of breast-feeding along with importance of the drug to the woman and any potential adverse effects of the drug on the breast-fed infant.

Pediatric Use

Safety and efficacy in pediatric patients supported by adequate and well-controlled studies in adults and additional safety data in pediatric patients ≥2 years of age.

Geriatric Use

In clinical trials of cenegermin-bkbj, 43.5% of patients were ≥65 years of age. No overall differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Eye pain, corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, increased lacrimation.

Drug Interactions

No formal drug interaction studies to date.

Cenegermin-bkbj (EENT) Pharmacokinetics

Absorption

Bioavailability

Extent of systemic exposure following ocular administration is unknown.

Distribution

Extent

Not known if the drug is distributed into milk following topical administration to the eye.

Stability

Storage

Ophthalmic

Solution

Unopened vials in pharmacy: Temperature not exceeding -20°C. Dispense carton containing 7 cenegermin-bkbj vials in the manufacturer-provided insulated package.

Unopened vials following dispensing from pharmacy: 2–8°C for ≤14 days; remove carton containing vials of drug from insulated package and refrigerate within 5 hours after leaving pharmacy. Do not refreeze.

Vials with inserted vial adapter: 2–25°C for 12 hours. Discard 12 hours after connecting adapter to vial.

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Cenegermin-bkbj (recombinant)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.002%

Oxervate (available in a kit containing seven 1-mL multiple-dose vials of the drug in an insulated package, 8 vial adapters, 45 pipettes and sterile disinfectant wipes, and a dose card)

Dompé

AHFS DI Essentials™. © Copyright 2024, Selected Revisions June 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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