Cenegermin-bkbj

Class: EENT Drugs, Miscellaneous
Chemical Name: Human beta-nerve growth factor (β-NGF)-(1-118)-peptide (noncovalent dimer) produced in Escherichia coli
Molecular Formula: C₅₈₃H₉₀₈N₁₆₆O₁₇₃S₈
CAS Number: 1772578-74-1
Brands: Oxervate

Medically reviewed by Drugs.com on Oct 25, 2021. Written by ASHP.

Introduction

Recombinant form of human nerve growth factor.

Uses for Cenegermin-bkbj

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 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 remai...