Rx Item-Dexycu- Dexamethasone Injection Suspension By Eyepoint Pharna

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DEXYCU� safely and effectively. See full prescribing information for DEXYCU.

DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration
Initial U.S. Approval: 1958
INDICATIONS AND USAGE
DEXYCU is a corticosteroid indicated for the treatment of postoperative inflammation (1).

DOSAGE AND ADMINISTRATION
For intraocular administration (2).
Administer 0.005 mL of DEXYCU into the posterior chamber inferiorly behind the iris at the end of ocular surgery (2).
DOSAGE FORMS AND STRENGTHS
Intraocular suspension: 9% equivalent to dexamethasone 103.4 mg/mL in a single-dose vial provided in a kit (3).

CONTRAINDICATIONS
None (4).

WARNINGS AND PRECAUTIONS
Increase in intraocular pressure (IOP): Monitor for increases in IOP (5.1).
Delayed Healing: Monitor for delayed healing (5.2).
Infection Exacerbation: Monitor and treat for any exacerbations of bacterial, viral or fungal infections (5.3).
Cataract Progression: Cataracts may develop or progress in phakic patients (5.4).
ADVERSE REACTIONS
In controlled studies, the most common adverse reactions reported by 5-15% of patients were intraocular pressure increased, corneal edema and iritis (6.1).


To report SUSPECTED ADVERSE REACTIONS, contact EyePoint Pharmaceuticals US at 1-833-EYEPOINT (1-833-393-7646) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Revised: 12/2018

DEXYCU- dexamethasone inj
NDC Code(s): 71879-001-01 Packager: EyePoint Pharmaceuticals US, Inc Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: New Drug Application

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DEXYCU- dexamethasone inj
NDC Code(s): 71879-001-01 Packager: EyePoint Pharmaceuticals US, Inc Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: New Drug Application