Oxervate (cenegermin-bkbj)

For the treatment of neurotrophic keratitis in adults and pediatric patients 2 years of age and older, 1 drop of cenegermin-bkbj 0.002% ophthalmic solution should be instilled into the conjunctival fornix of the affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.

Cenegermin-bkbj is applied topically to the affected eye(s) as a 0.002% ophthalmic solution. Cenegermin-bkbj ophthalmic solution is for topical ophthalmic use only.

Contact lenses should be removed prior to administration of each dose; lenses may be reinserted 15 minutes following administration.

If more than one topical ophthalmic drug is used in a patient receiving cenegermin-bkbj, the drugs should be administered at least 15 minutes apart to avoid diluting the preparations. Cenegermin-bkbj ophthalmic solution should be instilled 15 minutes before any ophthalmic ointment, gel, or other viscous drops. The patient should be instructed to blink several times after administration of each dose so that the drug covers the surface of the eye.

If a dose is missed, the usual administration schedule should be resumed with the next scheduled dose. An extra dose should not be administered to make up for a missed dose.

Cenegermin-bkbj 0.002% ophthalmic solution is 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. Prior to dispensing from a pharmacy, the drug should be stored in a freezer at a temperature not exceeding -20degreesC. Within 5 hours after the patient receives the drug from the pharmacy, the carton containing the 7 vials of drug should be removed from the insulated package and refrigerated at 2-8degreesC for up to 14 days. If the patient initiates treatment immediately after receiving the carton, the first vial should be allowed to thaw at room temperature up to 25degreesC (this may take up to 30 minutes) prior to preparation for use.

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) should be removed from the refrigerator and prepared for use by piercing the vial stopper with an adapter provided by the manufacturer. Once the vial adapter has been connected to the vial, it should not be removed. The vial should not be shaken. Prior to removing a dose from the vial, the adapter should be cleaned with a disinfectant wipe, and then a pipette should be screwed into the adapter to withdraw the dose. Once properly filled, the pipette should be disconnected from the adapter and the dose should be administered directly from the pipette into the conjunctival fornix. Each dose should be withdrawn from the vial 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, cenegermin ophthalmic solution should be administered again with a new pipette. After each use, the vial with connected adapter may be refrigerated or stored at room temperature up to 25degreesC; any unused amount remaining in the vial 12 hours after the adapter was connected should be discarded.

The manufacturer's instructions for use should be consulted for detailed information regarding preparation and ocular administration of cenegermin-bkbj ophthalmic solution.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no known contraindications to the use of cenegermin.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects occurring in 1% or more of patients receiving cenegermin 0.002% ophthalmic solution and reported more frequently with the drug than with the vehicle include eye pain, corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, and increased lacrimation.

Rare or Very Rare

• Corneal neovascularization

More Frequent

• Eye tearing
• Ocular inflammation
• Ocular pain
• Ocular redness

Less Frequent

• Corneal deposits
• Foreign body sensation of eye
• Headache disorder
• Photophobia

Rare or Very Rare

• Blepharitis

No enhanced messaging available.

Safety and efficacy of cenegermin-bkbj 0.002% ophthalmic solution in pediatric patients are supported by adequate and well-controlled studies in adults and additional safety data in pediatric patients 2 years of age and older.

Data are not available regarding use of cenegermin ophthalmic solution in pregnant women.

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

It is not known whether cenegermin is distributed into milk following topical application to the eye. Data also are not available regarding any effects of the drug on the breast-fed infant or on milk production. The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects of the drug on the breast-fed infant.

When the total number of patients studied in clinical trials of cenegermin-bkbj is considered, 43.5% were 65 years of age or older. No overall differences in safety and efficacy of cenegermin ophthalmic solution were observed between geriatric patients and younger adults.