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

Prescribing Information
OXERVATE® (cenegermin-bkbj ophthalmic solution) 0.002% (20 mcg/mL) Resolutionary Care logo
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Dosing & Administration

Emphasize to your patients the importance of treatment adherence—completion of the full 8-week course is critical for effective treatment.1

Dosing

A full 8-week course of OXERVATE® can resolve NK for most patients*1

Drop icon indicating 6 drops per day

Instill 1 drop
in the affected eye(s),
6 times daily

Clock face icon indicating 2 hours apart

Every
2 hours

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Calendar icon indicating continue for 8 weeks

Continue for
8 weeks

Adherence to the full 8-week course is critical for effective treatment2:

Every 2 hours, 6 times a day, for 8 weeks

*

Resolution was evaluated in clinical trials as complete corneal healing, defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment and as <0.5-mm lesion staining at 48-week follow-up.1-3

Administration

FDA-approved for all stages of NK in patients 2 years of age and older1

General Dosing Information

Contact lenses should be removed before applying OXERVATE® and may be reinserted 15 minutes after administration.

If a dose is missed, treatment should be continued as normal at the next scheduled administration.

If more than 1 topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer OXERVATE 15 minutes prior to using any eye ointment, gel, or other viscous eye drops.

Watch a demo on how to administer OXERVATE

The OXERVATE Kit

OXERVATE is supplied in a weekly carton in a cooler containing 7 multi-dose vials1

A separate weekly Delivery System Kit contains the supplies needed to administer treatment

Vial adaptor illustration

7 vial adapters for the week
+ 1 extra adapter

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42 pipettes for the week
+ 3 extra pipettes

Sterile disinfectant wipe illustration

42 sterile disinfectant wipes for the week + 3 extra wipes

Dose Recording Card illustration

Dose Recording Card

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Storage

The OXERVATE carton should be stored in the refrigerator1

Patients should refrigerate OXERVATE as soon as possible after receiving it

OXERVATE is shipped directly to patients in an insulated pack with dry ice.

Refrigerator with snowflake illustration

Storage of weekly cartons:

  • Refrigerate between 36°F to 46°F (2°C to 8°C) within 5 hours of delivery
  • Keep for up to 14 days
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Storage of opened vials:

  • Store in the original weekly carton
  • Keep refrigerated between 36°F to 46°F (2°C to 8°C) for up to 12 hours
  • May also be stored at room temperature, up to 77°F (25°C), for up to 12 hours
Clock face illustration with 12 hrs written inside
  • Do not refreeze OXERVATE
  • Do not shake the vial
  • Discard any unused portion after 12 hours
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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. Other adverse reactions occurring in 1% to 10% of OXERVATE patients and more frequently than in the vehicle-treated patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation and tearing.

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.

References: 1 . OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. Boston, MA; Dompé U.S. Inc.; 2019. 2. Bonini S, Lambiase A, Rama P, et al. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332-1343. 3. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26.