Iluvien

Indications and Usage, Chronic Non-Infectious Uveitis Affecting the Posterior Segment

ILUVIEN is a corticosteroid indicated for:

• the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
  1.1 Diabetic Macular Edema

  ILUVIEN^®is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
• the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
  1.2 Chronic Non-Infectious Uveitis Affecting the Posterior Segment

  ILUVIEN^®is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

• For ophthalmic intravitreal injection.
  2.1 General Dosing Information

  For ophthalmic intravitreal injection.

  The initial prescription and renewal of the medication order of ILUVIEN should be made by a physician only after examination of
  the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining.
• The intravitreal injection procedure should be carried out under aseptic conditions.
  2.2 Administration

  The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

  The injection procedure for ILUVIEN is as follows:
  
  
  
  

  • The exterior of the tray should
    not
    be considered sterile. An assistant (non-sterile) should remove the tray from the carton and examine the tray and lid for damage. If damaged, do not use unit.
    
    If acceptable, the assistant should peel the lid from the tray
    without touching the interior surface.
  • Visually check through the viewing window of the preloaded applicator to ensure that there is a drug implant inside.
  • Remove the applicator from the tray with sterile gloved hands
    touching only the sterile interior tray surface and applicator.
    
    
    Prior to injection, the applicator tip must be kept above the horizontal plane to ensure that the implant is properly positioned within the applicator.
  • To reduce the amount of air administered with the implant, the administration procedure requires two steps. Before inserting the needle into the eye, remove the protective cap then gently push the applicator button down and slide it to the first stop (at the curved black marks alongside the button track). At the first stop, release the button and it should move to the UP position. If the button does not rise to the UP position, do not proceed with this unit.
  • Optimal placement of the implant is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of calipers for point of entry into the sclera.
  • Inspect the tip of the needle to ensure it is not bent.
  • Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes. Insert the needle through the conjunctiva and sclera. To release the implant, while the button is in the UP position, advance the button by sliding it forward to the end of the button track and remove the needle. Note: Ensure that the button reaches the end of the track before removing the needle.
  • Remove the lid speculum and perform indirect ophthalmoscopy to verify placement of the implant, adequate central retinal artery perfusion and absence of any other complications.

  Following the injection, patients should be monitored for change in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report without delay any symptoms suggestive of endophthalmitis.
• Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis.
  2.2 Administration

  The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

  The injection procedure for ILUVIEN is as follows:
  
  
  
  

  • The exterior of the tray should
    not
    be considered sterile. An assistant (non-sterile) should remove the tray from the carton and examine the tray and lid for damage. If damaged, do not use unit.
    
    If acceptable, the assistant should peel the lid from the tray
    without touching the interior surface.
  • Visually check through the viewing window of the preloaded applicator to ensure that there is a drug implant inside.
  • Remove the applicator from the tray with sterile gloved hands
    touching only the sterile interior tray surface and applicator.
    
    
    Prior to injection, the applicator tip must be kept above the horizontal plane to ensure that the implant is properly positioned within the applicator.
  • To reduce the amount of air administered with the implant, the administration procedure requires two steps. Before inserting the needle into the eye, remove the protective cap then gently push the applicator button down and slide it to the first stop (at the curved black marks alongside the button track). At the first stop, release the button and it should move to the UP position. If the button does not rise to the UP position, do not proceed with this unit.
  • Optimal placement of the implant is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of calipers for point of entry into the sclera.
  • Inspect the tip of the needle to ensure it is not bent.
  • Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes. Insert the needle through the conjunctiva and sclera. To release the implant, while the button is in the UP position, advance the button by sliding it forward to the end of the button track and remove the needle. Note: Ensure that the button reaches the end of the track before removing the needle.
  • Remove the lid speculum and perform indirect ophthalmoscopy to verify placement of the implant, adequate central retinal artery perfusion and absence of any other complications.

  Following the injection, patients should be monitored for change in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report without delay any symptoms suggestive of endophthalmitis.

ILUVIEN is a non-bioerodable intravitreal implant in a drug delivery system containing 0.19 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day and lasting 36 months.

There are no adequate and well-controlled studies of ILUVIEN use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with fluocinolone acetonide. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. It is not known whether ILUVIEN can cause fetal harm when administered to a pregnant women or affect reproduction capacity. ILUVIEN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.