"The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter "...
RETISERT is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
DOSAGE AND ADMINISTRATION
RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is implanted into the posterior segment of the affected eye through a pars plana incision.
The implant contains one tablet of 0.59 mg of fluocinolone acetonide. RETISERT is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months. Following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis, RETISERT may be replaced.
Handling of Implant
Caution should be exercised in handling RETISERT in order to avoid damage to the implant, which may result in an increased rate of drug release from the implant. Thus, RETISERT should be handled only by the suture tab. Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
RETISERT should not be resterilized by any method.
Dosage Forms And Strengths
0.59 mg fluocinolone acetonide intravitreal implant.
Storage And Handling
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. Each RETISERT is approximately 3 mm x 2 mm x 5 mm.
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 which includes the package insert.
Storage: Store in the original container at 15° - 25°C (59° - 77°F). Protect from freezing.
Revised May 2011. Marketed by: Bausch & Lomb Incorporated Rochester, NY 14609. Manufactured by: Bausch & Lomb Incorporated., Waterford, Ireland
Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Retisert Information
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