Cenegermin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: October 25, 2024🚩 Report this page

Cenegermin

Other Ophthalmologicals

Sold as Oxervate

EU EMA

Drug class: Other Ophthalmologicals
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Cenegermin is an active pharmaceutical ingredient in the Other Ophthalmologicals group (S01XA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	October 25, 2024

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised October 25, 2024[1]

Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/004209 · revised October 25, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised October 25, 2024[1]

6 %). e. population included in clinical trials also on indications other than neurotrophic keratitis). Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies in patients suffering from neurotrophic keratitis, treated with OXERVATE 20 mcg/ml.
Adverse drug reactions are presented below according to MedDRA system organ classification (SOC and Preferred Term Level). They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
System organ class Frequency Adverse reaction Infections and infestations Uncommon Corneal abscess Nervous system disorders Common Headache Eye disorders Very common Eye pain Common Eye inflammation, eyelid pain, foreign body sensation in the eye, lacrimation increased, blepharitis, conjunctival hyperaemia, photophobia, eye irritation, corneal deposits.
Uncommon Corneal neovascularization Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised October 25, 2024[1]

4. 6. 1. 4 Special warnings and precautions for use Risk of corneal melting or impending perforation It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before starting therapy with OXERVATE as cenegermin should not be used in patients requiring immediate surgery.
Eye reactions OXERVATE may cause mild to moderate eye discomfort, such as eye pain, to the patient. The patient should be advised to contact the doctor in case of concern or a more severe eye reaction. 5). Eye infections An eye infection should be treated before use of OXERVATE.
2). 4 Ocular cancer Cenegermin may theoretically affect ocular cancer, as it is a growth factor. OXERVATE should be used with caution in patients with ocular cancer. It is recommended that these patients continue to be monitored for cancer progression during and after treatment with this medicinal product.
Contact lenses Patients should be instructed to remove contact lenses before applying OXERVATE and to wait 15 minutes after instillation of the dose before reinsertion, because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations