Label: RETISERT- fluocinolone acetonide implant

  • NDC Code(s): 24208-416-01
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 14, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use RETISERT safely and effectively. See full prescribing information for RETISERT. RETISERT (fluocinolone acetonide intravitreal ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    RETISERT - ®is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing Information - RETISERT 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    0.59 mg fluocinolone acetonide intravitreal implant.
  • 4 CONTRAINDICATIONS
    4.1 Viral, Bacterial, Mycobacterial and Fungal Infections of Ocular Structures - Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cataract Formation - Use of corticosteroids may result in posterior subcapsular cataract formation. Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Ocular Events - The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Adequate and well-controlled studies with RETISERT have not been conducted in pregnant women to inform drug-associated risk. Animal reproduction studies have not ...
  • 11 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to determine the carcinogenic potential or the effect on fertility of ...
  • 14 CLINICAL STUDIES
    In two randomized, double-masked, multicenter controlled clinical trials, 224 patients with chronic (a one year or greater history) non-infectious uveitis affecting the posterior segment of one or ...
  • 16 HOW SUPPLIED/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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT. As with any surgical procedure, there is risk ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    NDC24208-416-01 - Rx only - Retisert - ® (fluocinolone acetonide - intravitreal implant) 0.59 mg - STERILE - FOR INTRAVITREAL IMPLANTATION ONLY - Contents:One sterile Retisert ...
  • INGREDIENTS AND APPEARANCE
    Product Information