Dextenza Drug Information
Generic name: DEXAMETHASONE
Corticosteroid [EPC]
Uses of Dextenza
Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.
Itching 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. 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.
Dosage & Administration of Dextenza
General Dosing Information DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus. A single DEXTENZA insert releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is resorbable and does not require removal.
Saline irrigation or manual expression can be performed to remove the insert if necessary. DEXTENZA is intended for single-use only.
Administration
Do not use if pouch has been damaged or opened. Do not re-sterilize. Carefully remove foam carrier and transfer to a clean and dry area.
If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus during dilation or insertion of DEXTENZA. If perforation occurs, do not insert DEXTENZA.
After drying the punctal area, using blunt (non-toothed) forceps, grasp DEXTENZA and insert into the lower lacrimal canaliculus by pulling the lid temporally and inserting nasally. Ensure DEXTENZA is placed just below the punctal opening. Excessive squeezing of DEXTENZA with forceps may cause deformation.
To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into the punctum. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA.
DEXTENZA can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellow filter.
Side Effects of Dextenza
Clinical 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.
Ocular Inflammation and Pain Following Ophthalmic Surgery
DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n = 567). Forty-seven percent had brown iris color and 30% had blue iris color. The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).
Itching Associated with Allergic Conjunctivitis
Fifty seven percent had brown iris color and 20% had blue iris color.
Warnings & Cautions for Dextenza
Intraocular Pressure Increase
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment.
Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.
Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal Infections
Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
Delayed Healing
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Other Potential Corticosteroid Complications
The initial prescription and renewal of the medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Pregnancy Safety for Dextenza
Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations (see Data ). A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis.
Pediatric Use of Dextenza
Pediatric Use The safety and effectiveness of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery have been established in pediatric patients. The safety and effectiveness of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis have been established in 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.
Use of DEXTENZA for these indications is supported by evidence from adequate and well-controlled studies in adults with additional safety data from a single active-controlled study in pediatric patients aged birth to 5 years old. A similar safety profile was observed between pediatric and adult patients.
Contraindications for Dextenza
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. Active ocular infections.
Clinical Studies of Dextenza
Ocular Inflammation and Pain Following Ophthalmic Surgery
In three randomized, multicenter, double-masked, parallel group, vehicle-controlled efficacy trials, patients received Dextenza or its vehicle immediately upon completion of cataract surgery (NCT02034019, NCT02089113, NCT02736175). In all three trials, Dextenza had a higher proportion of patients than the vehicle group who were pain free on post-operative Day 8. On post-operative Day 14, in two of the three studies, Dextenza had a higher proportion of patients than the vehicle group who had an absence of anterior chamber cells that was statistically significant.
Results are shown in Table 1 and Table 2. Table 1: Percentage of Patients with Absence of Anterior Chamber Cells Table 2: Percentage of Patients with Absence of Pain
Itching associated with Allergic Conjunctivitis
In three randomized, multicenter, double-masked, parallel group, vehicle-controlled efficacy trials, patients received Dextenza or its vehicle utilizing a repeat conjunctival allergen challenge model (NCT02445326, NCT02988882, NCT04050865). In all three trials, Dextenza resulted in lower mean ocular itching scores compared with the vehicle group at all time points throughout the one-month duration of the study. In two of the three studies, a higher proportion of patients had statistically significant reductions in ocular itching on Day 8, at 3 minutes, 5 minutes and 7 minutes post-challenge in the Dextenza group than in the vehicle group.
Results are shown in Table 3. Table 3: Reduction in Ocular Itching
| Study 1 | Study 2 | Study 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| dextenza (N=164) | Vehicle (N=83) | Difference (95% CI) | dextenza (N=161) | Vehicle (N=80) | Difference (95% CI) | Dextenza (N=216) | Vehicle (N=222) | Difference (95% CI) | |||
| Visit | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |||||
| Day 14 | 54 (33%) | 12 (14%) | 18% (8%, 29%) | 63 (39%) | 25 (31%) | 8% (-5%, 21%) | 113 (52%) | 69 (31%) | 21 % (12%, 30%) | ||
| Study 1 | Study 2 | Study 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Dextenza (N=164) | Vehicle (N=83) | Difference (95% CI) | Dextenza (N=161) | Vehicle (N=80) | Difference (95% CI) | Dextenza (N=216) | Vehicle (N=222) | Difference (95% CI) | |||
| Visit | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |||||
| Day 8 | 131 (80%) | 36 (43%) | 37% (24%, 49%) | 124 (77%) | 47 (59%) | 18% (6%, 31%) | 172 (80%) | 136 (61%) | 18% (10%, 27%) | ||
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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