HANDLING AND INSERTION OF DEXTENZA

Handling the insert1

Carefully remove the foam carrier from the foil pouch and transfer to a clean and dry area.

Dry insert dimensions2:

~0.55 mm in diameter
and 3 mm in length.

Inserting into the canaliculus1

DILATE the punctum, if necessary, with an ophthalmic dilator. Avoid perforating the canaliculus. If perforation occurs, do not insert.

DRY the punctal area. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA.

INSERT into the lower lacrimal canaliculus just below the punctal opening using blunt (non-toothed) forceps. Excessive squeezing of DEXTENZA may cause deformation.

Insertion of DEXTENZA
is minimally invasive3-5

Once inserted1

  • To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into the punctum
  • DEXTENZA can be visualized by a blue light source (e.g.,slit lamp or handheld blue light) with a yellow filter

STORAGE AND HANDLING

How DEXTENZA is supplied1

DEXTENZA is supplied sterile in a foam carrier within a foil laminate pouch:

  • NDC 70382-204-10 Carton containing 10 pouches (10 inserts)
  • NDC 70382-204-01 Carton containing 1 pouch (1 insert)

Proper storage and handling1

  • Store refrigerated, between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light, keep in package until use.
  • Do not use if pouch has been damaged or broken.
  • DEXTENZA is intended for single dose only.

References: 1. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2019. 2. Data on file 00575. Ocular Therapeutix, Inc. 3. Walters T, et al. J Clin Exp Ophthalmol. 2016;7(4):1-11. 4. Minimally invasive [definition]. https://www.dictionary.com/browse/minimally-invasive. Accessed January 8, 2019. 5. Misra A, Shahiwala A, eds. Applications of Polymers in Drug Delivery. Shawbury, Shrewsbury, Shropshire, UK: Smithers Rapra; 2014.

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Full Prescribing Information
INDICATION

DEXTENZA is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

IMPORTANT SAFETY INFORMATION

Contraindications
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.

Warnings and Precautions
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 treatment.

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.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

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.

Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Adverse Reactions
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%).

Please see Full Prescribing Information.