Cenegermin-bkbj

Cenegermin-bkbj Uses, Dosage, Side Effects, Food Interaction and all others data.

Cenegermin-bkbj is a human beta-nerve growth factor (beta-ngf)-(1-118)- peptide (non-covalent dimer) produced in escherichia coli. It received European Union Approval in July, 2017 for the treatment of moderate to severe neurotrophic keratitis. Cenegermin-bkbj received approval from the US FDA a year later in August of 2018 .

Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation . The loss of corneal sensation impairs corneal health causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases . The prevalence of neurotrophic keratitis has been estimated to be less than five in 10,000 individuals .

While the prevalence of neurotrophic keratitis is low, the impact of this serious condition and its associated sequelae on an individual patient can be debilitating. Many currently available therapeutic options for treating the condition involve surgical interventions - surgeries that are typically only palliative . The approval of cenegermin consequently provides a novel topical treatment that has the potential capacity to offer total corneal healing for many patients who may use the agent .

Cenegermin-bkbj
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Cenegermin-bkbj
Generic	Cenegermin
Cenegermin Other Names	Cenegermin, cenegermin-bkbj, rhNGF
Type	Ophthalmic
Protein binding	In general, the systemic absorption of cenegermin is negligible .
Groups	Approved, Investigational
Therapeutic Class
Manufacturer
Available Country	United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Cenegermin-bkbj is a recombinant human nerve growth factor used to treat neurotrophic keratitis.

Cenegermin-bkbj is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults .

Cenegermin-bkbj is also used to associated treatment for these conditions: Neurotrophic Keratitis

How Cenegermin-bkbj works

Cenegermin-bkbj is a recombinant form of human nerve growth factor .

Nerve growth factor is subsequently an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors . Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues . The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity .

Toxicity

There are no data from the use of cenegermin in pregnant women . Systemic exposure to cenegermin is negligible or does not occur . As a precautionary measure, it is preferable to avoid the use of OXERVATE during pregnancy .

It is not known whether cenegermin is excreted in human milk . A risk to the suckling child cannot be excluded . A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman .

The safety and effectiveness of cenegermin have been established in the pediatric population . Use of cenegermin in this population is supported by evidence from adequate and well controlled trials of cenegermin in adults with additional safety data in pediatric patients from 2 years of age and older .

Of the total number of subjects in clinical studies of cenegermin, 43.5 % were 65 years old and over . No overall differences in safety or effectiveness were observed between elderly and younger adult patients .

There are no data on the effects of cenegermin on human fertility .

Food Interaction

No interactions found.

Volume of Distribution

After eye drop administration, cenegermin is distributed particularly in the anterior portion of the eye, although a study with radiolabelled cenegermin in rats has shown that it also reaches the retina and other posterior parts of the eye at doses significantly higher than those administered by eye drops in humans to treat neurotrophic keratitis . At the ocular doses, cenegermin is not distributed throughout body tissues as there is no systemic absorption above the natural baseline levels .

Elimination Route

Cenegermin-bkbj is mostly removed from the eye with the tear production and through the naso-lacrimal duct; the minor portion that is absorbed occurs mostly in the conjunctiva and peri-orbital tissue and to a minor extent through the cornea following ocular administration . Pharmacokinetic profiling of patients included in studies found no accumulation effect of cenegermin . In general, the systemic absorption of cenegermin is negligible .

Half Life

Half life data specific to human administration is not readily accessible or available .

Clearance

ALthough the systemic absorption of cenegermin is negligible in general , clearance data specific to human administration is not readily accessible or available .