Two views of Retisert and its delivery system

In patients with chronic noninfectious posterior uveitis

Designed to Deliver Inflammation Control





Description





RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3 to 0.4 μg/day over approximately 30 months.

How Supplied

The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive.

Inactive Ingredients

Microcrystalline cellulose, polyvinyl alcohol, and magnesium stearate.



What's Included Inside the Package





Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap. Each packaged implant is provided in a carton that includes the package insert. Please note the external surface of the foil pouch is not sterile. However, the contents of the foil pouch are sterile.

Shipping:

Every unit of RETISERT® ships with a suture pack containing one 8-0 Prolene suture and one 9-0 Prolene suture.

NDC#

24208-0416-01

Storage conditions:

Store in the original container at 15ºC to 25ºC (59ºF–77ºF). Protect from freezing.



Ordering Information





RETISERT® ordering:

Call 800-321-4576, then press 4
Mon-Fri / 8AM - 5PM EST

RETISERT® reimbursement assistance:

FOCUS ON ACCESS™ (866) 272-8838
Mon-Fri / 8AM - 5PM EST




Indication and Usage





RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is used to treat an inflammation in the back of the eye that is not caused by an infection, called chronic non-infectious uveitis.

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Important Safety Information





  • Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg should not be used if you have an infection of the eye from viruses, bacteria, fungi or fungal diseases.

  • After receiving the Retisert® implant, you should periodically see an eye doctor for follow-up examinations of both eyes.

  • As with any surgical procedure, there is risk involved. Complications can include injury to the eye; infection; mechanical complication, movement or ejection of the implant; and wound complications following the surgery.

  • After receiving the Retisert® implant, nearly all patients will experience an immediate and temporary decrease in vision in the implanted eye that lasts for approximately 1 to 4 weeks following the surgery.

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, approximately 77% of patients require medications to lower pressure in the eye, and approximately 37% of patients will require a surgical procedure to control pressure in the eye.

  • Long-term use of corticosteroids may result in an increased risk of glaucoma (high pressure in the eye).

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, nearly all patients who have not already had cataracts will develop them and require surgery.

  • The most common side effects, occurring in 50-90% of patients, were cataract, increased pressure in the eye, surgery complications and eye pain. Headache was also reported in greater than 33% of patients



Please see full Prescribing Information for Retisert®

You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.