dexamethasone ophthalmic insert (Rx)

Brand and Other Names:Dextenza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic intracanalicular insert

  • 0.4mg

Ocular Pain

Bioresorbable hydrogel-based drug-eluting intracanalicular depot indicated for ocular pain following ophthalmic surgery

Insert in lower lacrimal punctum into the canaliculus; a single insert releases 0.4 mg for up to 30 days following insertion

Insert is resorbable and does not require removal; perform saline irrigation or manual expression to remove the insert if necessary

Safety and efficacy not established

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Adverse Effects

1-10%

Anterior chamber inflammation including iritis and iridocyclitis (9%)

Increased intraocular pressure (IOP) (5%)

Visual acuity reduced (2%)

Eye pain (1%)

Cystoid macular edema (1%)

Corneal edema (1%)

Conjunctival hyperemia (1%)

Headache (1%)

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Warnings

Contraindications

Active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye; dacryocystitis

Cautions

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity, and defects in fields of vision; caution if used in the presence of glaucoma; monitor IOP

Corticosteroids may suppress immune response and increase risk for secondary ocular infections; may also mask infection and enhance existing infection

Ocular corticosteroids may prolong viral eye infections and exacerbate severity

Consider fungal invasion with any persistent corneal ulceration while using ocular corticosteroids

Use after cataract surgery may delay healing and increase bleb formation incidence

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Pregnancy

Pregnancy

Data are not available regarding use in pregnant women

Animal data

  • Topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate, and multiple visceral malformations
  • In mice, topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10-13 produced embryofetal lethality and a high incidence of cleft palate; 0.75 mg/kg/day in mice is ~5x the entire dose of dexamethasone in the Dextenza product (based on body surface)
  • In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg/day, on gestational day 6, then 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis, and hypoplastic kidneys; 0.24 mg/day is ~6x the entire dose of dexamethasone in the Dextenza product (based on body surface)

Lactation

Unknown if distributed in human breast milk

Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however, systemic concentration of dexamethasone following administration of Dextenza is low

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Corticosteroid; decreases postoperative ocular pain by suppressing inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Low plasma concentrations were detectable (>50 pg/mL, lower limit of quantification) in 11% of samples (21 of 189), and ranged from 0.05-0.81 ng/mL

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Administration

Intracanalicular Administration

For single intracanalicular use only

Do not use if pouch damaged or opened; do not resterilize

Instructions

  • Carefully remove foam carrier and transfer to a clean and dry area
  • If necessary, dilate punctum with an ophthalmic dilator; do not perforate the canaliculus during dilation or insertion of dexamethasone; if perforation occurs, do not insert dexamethasone
  • After drying punctal area, use blunt (nontoothed) forceps to grasp dexamethasone and insert into the lower lacrimal canaliculus; it should be placed just below the punctal opening; excessively squeezing the insert may cause deformation
  • To aid hydration, instill 1-2 drops of balanced salt solution into punctum; insert hydrates quickly upon contact with moisture
  • If dexamethasone begins to hydrate before fully inserted, discard product and use a new dexamethasone
  • Inserts can be visualized when illuminated by a blue light source (eg, slit lamp or hand held blue light) with yellow filter

Storage

Store refrigerated, between 2-8°C (36-46°F)

Do not freeze

Protect from light; keep in package until use

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.