Rx Item-OXERVATE- cenegermin-bkbj othalmic sol 0.002% (20 mcg/mL) 7 MDV by Domp

Neurotrophic Keratitis

Oxervate (cenegermin) is a recombinant human nerve growth factor (rhNGF) ophthalmic solution indicated for the treatment of neurotrophic keratitis. These highlights do not include all the information needed to use OXERVATE safely and effectively. See full prescribing information for OXERVATE.

OXERVATETM (cenegermin-bkbj) ophthalmic solution, for topical ophthalmic use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. (1)
DOSAGE AND ADMINISTRATION

One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks. (2.1)
DOSAGE FORMS AND STRENGTHS

Ophthalmic solution: cenegermin-bkbj 0.002% (20 mcg/mL) in a multiple-dose vial. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. (5.1)

ADVERSE REACTIONS

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Domp� U.S. Inc. at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2019 OXERVATE (cenegermin-bkbj) ophthalmic solution, 0.002% (20 mcg/mL), is a sterile, preservative free clear, colorless solution in a multiple-dose vial, closed with a rubber stopper (not made with natural rubber latex), and an aluminum overseal with a polypropylene flip-off cap.

OXERVATE is supplied in weekly cartons containing 7 multiple-dose vials (NDC 71981-020-07) in an insulated pack with the Delivery System Kit (NDC 71981-001-01). The Delivery System Kit contains 8 vial adapters, 45 pipettes, 45 sterile disinfectant wipes, and 1 Dose Recording Card.

Pharmacy Storage
Store the weekly cartons in the freezer at or below -4�F (-20�C). Supply the weekly cartons in an insulated pack in combination with the Delivery System Kit.

Patient Storage
Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36�F to 46�F (2�C to 8�C) for up to 14 days. A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36�F to 46�F (2�C to 8�C) or at room temperature up to 77�F (25�C), for up to 12 hours [see Dosage and Administration (2.1)]. Do not refreeze the vials. Do not shake the vials. Discard the opened vial after 12 hours even if there is still some solution left inside.

Rx Item-OXERVATE- cenegermin-bkbj othalm
https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxervate-carton.jpg&setid=89e4bfec-d710-40ed-8885-5d13ba46b1cd&type=img

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