Important Safety Information Prescribing Information
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OXERVATE® (cenegermin-bkbj)
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Important Safety Information Prescribing Information Dompé Site Patient Site
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RESOURCES

A Library of Resources Is Available to Help
You, Your Patients, and Your Office at
Every Stage of the OXERVATE® Journey

For eye care professionals and office staff

Prescription resources

Patient Enrollment Form

OXERVATE prescription and patient enrollment form

Download

Patient Authorization Form (English and Spanish)

Patient consent form to be used when E-prescribing

View (English) View (Spanish)

Access resources

Access Overview Brochure

An overview of the access process and financial assistance support programs

Download

Dompé CONNECT to Care Access and Fulfillment Guide

A comprehensive guide to OXERVATE prescription and treatment through Dompé CONNECT to Care, focused on the needs of the office staff

Download

Accredo Specialty Pharmacy Access and Fulfillment Guide

A comprehensive guide to OXERVATE prescription and treatment through Accredo, focused on the needs of the office staff

Download

Appeal resources

Letter of Medical Necessity

Sample document to provide guidance on communicating clinical rationale and the need for treatment access

Download

Appeal Letter Guide

Sample appeal letter used to provide guidance on the OXERVATE appeal process

Download

Prior Authorization (PA) Checklist

Reference guide detailing the most common health plan requirements for PA to help ensure complete and accurate submissions

Download

For patients

Getting your patients started on OXERVATE

Dompé CONNECT to Care Patient Access Guide

A resource to help patients understand what to expect during the approval process for OXERVATE, with a dedicated Dompé CONNECT to Care team available to answer questions and provide support

Download

Accredo Specialty Pharmacy Patient Access Guide

A guide to help patients learn about Accredo and how your office uses it to get them started on OXERVATE faster

Download

Patient education

Patient Brochure

Patient-friendly overview of neurotrophic keratitis (NK), OXERVATE, and the access process

Download

OXERVATE Administration Video (English and Spanish)

Important instructions for dosing and administering OXERVATE

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For US healthcare professionals only.

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Indication and Important Safety Information

WARNINGS AND PRECAUTIONS

Use with Contact Lens
Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

Eye Discomfort
OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

ADVERSE REACTIONS
In clinical trials, the most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Eye pain may arise as corneal healing occurs. Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.

USE IN SPECIFIC POPULATIONS

Pregnancy
There are no data from the use of OXERVATE in pregnant women to inform any drug associated risks.

Lactation
The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for OXERVATE, and any potential adverse effects on the breastfed infant from OXERVATE.

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

INDICATION
OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.

DOSAGE AND ADMINISTRATION
Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.

To report ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1‌-‌8‌3‌3‌-‌3‌6‌6‌-‌7‌3‌8‌7 or FDA at 1‌-‌8‌0‌0‌-‌F‌D‌A‌-‌1‌0‌8‌8 or www.fda.gov/medwatch.

Please see full Prescribing Information for OXERVATE.

Indication and Important Safety Information

OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.

WARNINGS AND PRECAUTIONS

Use with Contact Lens
Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

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