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SIZE0.7-mg implant

PRODUCT INFORMATIONDESCRIPTIONNDCOZURDEX®

0023-3348-07(dexamethasone intravitreal implant)
preloaded in a single-use applicator

For additional information about OZURDEX®, visit Ozurdex.com
INDICATIONS AND USAGE
Diabetic Macular EdemaOZURDEX® (dexamethasone intravitreal implant) is acorticosteroid indicated for the treatment of diabetic
macular edema.
IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® iscontraindicated in patients with active or suspected ocularor periocular infections including most viral diseases of thecornea and conjunctiva, including active epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, varicella,
mycobacterial infections, and fungal diseases.
Please see additional Indications and Important Safety
Information on the following pages.

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REIMBURSEMENT INFORMATION
AND ASSISTANCE:

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You can also access reimbursement assistanceat AllerganEyeCue.com

ALLERGAN MEDICALINFORMATION DEPARTMENT:

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For all other questions
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INDICATIONS AND USAGE (continued)
Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of macular edema
following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.
IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)
Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greaterthan 0.8.

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IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)
Torn or Ruptured Posterior Lens Capsule: OZURDEX® (dexamethasone intravitreal implant) is
contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk ofmigration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not acontraindication for OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any
components of this product.
Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections, including those with OZURDEX®, havebeen associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinaldetachments. Patients should be monitored regularly following the injection.
Steroid-related Effects: Use of corticosteroids including OZURDEX® may produce posterior
subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishmentof secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex
because of the potential for reactivation of the viral infection.
Adverse Reactions
Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined
3-year clinical trials following injection of OZURDEX® for diabetic macular edema include: cataract(68%), conjunctival hemorrhage (23%), visual acuity reduced (9%), conjunctivitis (6%), vitreous floaters(5%), conjunctival edema (5%), dry eye (5%), vitreous detachment (4%), vitreous opacities (3%), retinalaneurysm (3%), foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior chamber
inflammation (2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular adverse reactions reported bygreater than or equal to 5% of patients include: hypertension (13%) and bronchitis (5%).
Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline atany visit was seen in 28% of OZURDEX® patients versus 4% of sham patients. 42% of the patients who
received OZURDEX® were subsequently treated with IOP-lowering medications during the study versus
10% of sham patients.
The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned tobaseline between treatment cycles (at the end of the 6-month period).
Please see additional Important Safety Information on the back page.

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Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under controlled
aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressureand for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
IMPORTANT SAFETY INFORMATION (continued)
Adverse Reactions (continued)
Diabetic Macular Edema (continued)
Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye washigher in the OZURDEX® (dexamethasone intravitreal implant) group (68%) compared with Sham (21%). The mediantime of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12
months in the Sham group. Among these patients, 61% of OZURDEX® subjects versus 8% of sham-controlled subjects
underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20for Sham) of the studies.
Retinal Vein Occlusion and Posterior Segment Uveitis
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal
vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage(22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%),
and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of thepatients who received OZURDEX® required surgical procedures for management of elevated IOP.
Please see accompanying full Prescribing Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf© 2023 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.
US-OZU-230015 March 2023 021102
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