For the treatment of all stages of neurotrophic keratitis (NK)

Prescribing Information

 

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General questions

Since approval in 2018, more than 2000 total ophthalmologists and optometrists have prescribed OXERVATE®1

Patient Enrollment

How to enroll a patient

Submit a Patient Enrollment Form

A completed enrollment form serves as the OXERVATE® prescription and enrolls the patient into Dompé CONNECT to Care.

1

Fax completed enrollment form
on the patient’s behalf.

OR
2

Use the iAssist digital portal
to complete enrollment.

Remember: Patient Authorization section of enrollment form must be completed.

Questions? Contact Dompé CONNECT to Care

Fax 1-855-263-1775

With Dompé copay support, a majority of patients with commercial insurance who were prescribed OXERVATE paid no more than $100 out-of-pocket for an 8-week course of therapy1

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For US healthcare professionals only.

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.

Reference: 1. Data on File. Dompé U.S. Inc., 2022.