Dextenza (dexamethasone): FDA label

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Indications

DEXTENZA ® is a corticosteroid indicated for: The treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients. ( 1.1 ). The treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older. The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure.

( 1.2 ).

1.1Ocular Inflammation and Pain Following Ophthalmic Surgery

DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery ( 1.1 ).

1.2Itching Associated with Allergic Conjunctivitis

DEXTENZA is indicated for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older ( 1.2 ). Limitations of Use The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure [see Use in Specific Populations ( 8.4 )] .

Warnings and precautions

Intraocular Pressure Increase : Monitor intraocular pressure ( 5.1 ). Bacterial Infections : Steroids may mask signs of infections and enhance existing infections ( 5.2 ). Viral Infections : Ocular steroids may prolong the course and exacerbate the severity of ocular viral infections ( 5.3 ). Fungal Infections : Consider fungal invasion in any persistent corneal ulceration ( 5.4 ). Delayed Healing : Ocular steroids may slow the rate of ocular healing.

Adverse reactions

The following serious adverse reactions are described elsewhere in the labeling: Intraocular Pressure Increase [see Warnings and Precautions ( 5.1 )] Bacterial Infection [see Warnings and Precautions ( 5.2 )] Viral Infection [see Warnings and Precautions ( 5.3 )] Fungal Infection [see Warnings and Precautions ( 5.4 )] Delayed Healing [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure.

These occurred in approximately 6-10% of patients ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ocular Therapeutix at 1-800-DEXTENZA (339-8369) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions ( 5 )] .

6.2Ocular Inflammation and Pain Following Ophthalmic Surgery

DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n = 567). The mean age of the population was 68 years (range 35 to 87 years), 59% were female, and 83% were white. Forty-seven percent had brown iris color and 30% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%).

The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).

6.3Itching Associated with Allergic Conjunctivitis

DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n= 154). The mean age of the population was 41 years (range 19 to 69 years), 55 % were female and 61 % were white. Fifty seven percent had brown iris color and 20% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (1%).

The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).

Dextenza

Indications

1.1Ocular Inflammation and Pain Following Ophthalmic Surgery

1.2Itching Associated with Allergic Conjunctivitis

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Intraocular Pressure Increase

5.2Bacterial Infection

5.3Viral Infections Use

5.4Fungal Infections

5.5Delayed Healing

5.6Other Potential Corticosteroid Complications

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Ocular Inflammation and Pain Following Ophthalmic Surgery

6.3Itching Associated with Allergic Conjunctivitis

Composition

Official product information

At a glance

Guidelines