Fluocinolone Intraocular

1 implant, containing 1 tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye through a pars plana incision

Comments:
-Following depletion of this drug as evidenced by recurrence of uveitis, the implant may be replaced.
-Caution should be used in handling the implant to avoid damage, which may result in an increased rate of drug release from the implant.
-Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
-The implant should not be resterilized by any method.

Use: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

Data not available

Data not available

0.19 mg intravitreal implant: Safety and efficacy have not been established in patients younger than 18 years.

0.59 mg intravitreal implant: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-The manufacturer product information should be consulted.

Storage requirements:
-Do not refrigerate or freeze.
-Do not open the sealed tray until just before application

Animal reproduction studies have not been conducted. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use should be avoided. US FDA pregnancy category: C