Generic Name
Fluocinolone Acetonide
Brand Names
YUTIQ, Synalar, Flac, Dermotic, Derma-Smoothe, Neo-Synalar, Iluvien, Retisert
FDA approval date: June 11, 1963
Classification: Corticosteroid
Form: Ointment, Cream, Oil, Implant, Solution
What is YUTIQ (Fluocinolone Acetonide)?
Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Approved To Treat
Top Global Experts
There are no experts for this drug
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
There is no clinical trials being done for this treatment
Related Latest Advances
There is no latest advances for this treatment
Brand Information
YUTIQ (fluocinolone acetonide)
1INDICATIONS AND USAGE
YUTIQ
2DOSAGE FORMS AND STRENGTHS
YUTIQ is a non-bioerodible intravitreal implant in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day, and lasting 36 months.
3DESCRIPTION
YUTIQ is a sterile non-bioerodible intravitreal implant containing 0.18 mg fluocinolone acetonide in a 36-month sustained-release drug delivery system. YUTIQ is designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day. YUTIQ is preloaded into a single-dose applicator to facilitate injection of the implant directly into the vitreous. The drug substance is a synthetic corticosteroid, fluocinolone acetonide.
The chemical name for fluocinolone acetonide is (6α,11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-pregna-1,4-diene-3,20-dione. Its chemical structure is:
MW 452.50; molecular formula C
Fluocinolone acetonide is a white or almost white, microcrystalline powder, practically insoluble in water, soluble in methanol, ethanol, chloroform and acetone, and sparingly soluble in ether.
Each YUTIQ consists of a light brown 3.5mm x 0.37mm implant containing 0.18 mg of the active ingredient fluocinolone acetonide and the following inactive ingredients: polyimide tube, polyvinyl alcohol, silicone adhesive and water for injection.
4CLINICAL STUDIES
The efficacy of YUTIQ was assessed in two randomized (2:1, YUTIQ: sham-injection), multi-centre, double-masked, parallel-groups studies (NCT #01694186 and #02746991) that enrolled patients with non-infectious uveitis affecting the posterior segment of the eye. The primary efficacy endpoint in both trials was the proportion of patients who experienced a recurrence of uveitis in the study eye within 6 months of follow-up; recurrence was also assessed at 12 months. Recurrence of uveitis was defined as either deterioration in visual acuity, vitreous haze attributable to non-infectious uveitis or the need for rescue medications.
Figure 2: Time to First Recurrence of Uveitis (ITT: All Randomized Patients)
5HOW SUPPLIED/STORAGE AND HANDLING
YUTIQ
NDC 71879-136-01
6PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 71879-136-01
0.18 mg
Contains:
Each implant contains:
Dispose of the applicator
Rx Only. Store at 15° C to
