HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OZURDEX ® safely and effectively. See full prescribing information for OZURDEX ®.
OZURDEX(dexamethasone intravitreal implant)For Intravitreal Injection
Initial U.S. Approval: 1958
RECENT MAJOR CHANGES
Indications and Usage (1.3)
Contraindications (4.2, 4.3, 4.4)
Warnings and Precautions (5.2)
9/2014
9/2014
9/2014
INDICATIONS AND USAGE
OZURDEX® is a corticosteroid indicated for:
The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) (1.1)
The treatment of non-infectious uveitis affecting the posterior segment of the eye (1.2)
The treatment of diabetic macular edema (1.3)
DOSAGE AND ADMINISTRATION
For ophthalmic intravitreal injection. (2.1)
The intravitreal injection procedure should be carried out under controlled aseptic conditions. (2.2)
Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. (2.2)
DOSAGE FORMS AND STRENGTHS
Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system. (3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Glaucoma (4.2)
Torn or ruptured posterior lens capsule (4.3)
Hypersensitivity (4.4)
WARNINGS AND PRECAUTIONS
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. (5.1)
Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. (5.2)
ADVERSE REACTIONS
In controlled studies, the most common adverse reactions reported by 20–70% of patients were cataract, increased intraocular pressure and conjunctival hemorrhage. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Retinal Vein Occlusion
1.2 Posterior Segment Uveitis
1.3 Diabetic Macular Edema
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Glaucoma
4.3 Torn or Ruptured Posterior Lens Capsule
4.4 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Intravitreal Injection-related Effects
5.2 Steroid-related Effects
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
1.1 Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitr |
