Medical Editor: John P. Cunha, DO, FACOEP
What Is Yutiq?
Yutiq (fluocinolone acetonide intravitreal implant) contains a corticosteroid and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
What Are Side Effects of Yutiq?
Yutiq may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- blurred vision,
- tunnel vision,
- problems with peripheral (side) vision,
- eye redness,
- eye pain or swelling,
- seeing halos around lights,
- bleeding, oozing, or crusting of your eyes,
- flashes of light or “floaters” in your vision, and
- cloudiness in your pupil or iris (colored part of your eyes)
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Yutiq include:
- cataract development and increased intraocular pressure,
- decreased visual sharpness,
- eye swelling,
- uveitis,
- bleeding in the eye,
- eye pain,
- decreased intraocular pressure, and
- dry eye
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Yutiq
Yutiq is a non-bioerodible intravitreal implant in a drug delivery system containing a dose of 0.18 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day, and lasting 36 months.
What Drugs, Substances, or Supplements Interact with Yutiq?
Yutiq may interact with other drugs. Tell your doctor all medications and supplements you use.
Yutiq During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Yutiq; it is unknown how it would affect a fetus. Consult your doctor before breastfeeding.
Additional Information
Our Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg, for Intravitreal Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
What causes dry eyes? See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- blurred vision, tunnel vision, problems with peripheral (side) vision;
- eye redness, eye pain or swelling, seeing halos around lights;
- bleeding, oozing, or crusting of your eyes;
- flashes of light or "floaters" in your vision; or
- cloudiness in your pupil or iris (colored part of your eyes).
Common side effects may include:
- mild eye redness or pain;
- feeling like something is in your eye;
- headache; or
- your eyes may be more sensitive to light.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Pink Eye (Conjunctivitis) Symptoms, Causes, Treatments See SlideshowSIDE EFFECTS
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions associated with ophthalmic steroids including YUTIQ include cataract formation and subsequent cataract surgery, elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Studies 1 and 2 were multicenter, randomized, sham injection-controlled, masked trials in which patients with non-infectious uveitis affecting the posterior segment of the eye were treated once with either YUTIQ or sham injection, and then received standard care for the duration of the study. Study 3 was a multicenter, randomized, masked trial in which patients with non-infectious uveitis affecting the posterior segment of the eye were all treated once with YUTIQ, administered by one of two different applicators, and then received standard care for the duration of the study.
Table 1 summarizes data available from studies 1, 2 and 3 through 12 months for study eyes treated with YUTIQ (n=226) or sham injection (n=94). The most common ocular (study eye) and non-ocular adverse reactions are shown in Table 1 and Table 2.
Table 1: Ocular Adverse Reactions Reported in ≥ 1% of Subject Eyes and Non-Ocular Adverse Reactions Reported in ≥ 2% of Patients
| Ocular | ||
| ADVERSE REACTIONS | YUTIQ (N=226 Eyes) n (%) |
Sham Injection (N=94 Eyes) n (%) |
| Cataract1 | 63/113 (56%) | 13/56 (23%) |
| Visual Acuity Reduced | 33 ( 15%) | 11 (12%) |
| Macular Edema | 25 ( 11%) | 33 (35%) |
| Uveitis | 22 ( 10%) | 33 (35%) |
| Conjunctival Hemorrhage | 17 ( 8%) | 5 ( 5%) |
| Eye Pain | 17 ( 8%) | 12 (13%) |
| Hypotony Of Eye | 16 ( 7%) | 1 ( 1%) |
| Anterior Chamber Inflammation | 12 ( 5%) | 6 ( 6%) |
| Dry Eye | 10 ( 4%) | 3 ( 3%) |
| Vitreous Opacities | 9 ( 4%) | 8 ( 9%) |
| Conjunctivitis | 9 ( 4%) | 5 ( 5%) |
| Posterior Capsule Opacification | 8 ( 4%) | 3 ( 3%) |
| Ocular Hyperemia | 8 ( 4%) | 7 ( 7%) |
| Vitreous Haze | 7 ( 3%) | 4 ( 4%) |
| Foreign Body Sensation In Eyes | 7 ( 3%) | 2 ( 2%) |
| Vitritis | 6 ( 3%) | 8 ( 9%) |
| Vitreous Floaters | 6 ( 3%) | 5 ( 5%) |
| Eye Pruritus | 6 ( 3%) | 5 ( 5%) |
| Conjunctival Hyperemia | 5 ( 2%) | 2 ( 2%) |
| Ocular Discomfort | 5 ( 2%) | 1 ( 1%) |
| Macular Fibrosis | 5 ( 2%) | 2 ( 2%) |
| Glaucoma | 4 ( 2%) | 1 ( 1%) |
| Photopsia | 4 ( 2%) | 2 ( 2%) |
| Vitreous Hemorrhage | 4 ( 2%) | 0 |
| Iridocyclitis | 3 ( 1%) | 7 ( 7%) |
| Eye Inflammation | 3 ( 1%) | 2 ( 2%) |
| Choroiditis | 3 ( 1%) | 1 ( 1%) |
| Eye Irritation | 3 ( 1%) | 1 ( 1%) |
| Visual Field Defect | 3 ( 1%) | 0 |
| Lacrimation Increased | 3 ( 1%) | 0 |
| Non-ocular | ||
| ADVERSE REACTIONS | YUTIQ (N=214 Patients) n (%) | Sham Injection (N=94 Patients) n (%) |
| Nasopharyngitis | 10 ( 5%) | 5 ( 5%) |
| Hypertension | 6 ( 3%) | 1 ( 1%) |
| Arthralgia | 5 ( 2%) | 1 ( 1%) |
| 1. Includes cataract, cataract subcapsular and lenticular opacities in study eyes that were phakic at baseline. 113 of the 226 YUTIQ study eyes were phakic at baseline; 56 of 94 sham-controlled study eyes were phakic at baseline. | ||
Table 2: Summary of Elevated IOP Related Adverse Reactions
| ADVERSE REACTIONS | YUTIQ (N=226 Eyes) n (%) |
Sham (N=94 Eyes) n (%) |
| IOP elevation ≥ 10 mmHg from Baseline | 50 (22%) | 11 (12%) |
| IOP elevation > 30 mmHg | 28 (12%) | 3 (3%) |
| Any IOP-lowering medication | 98 (43%) | 39 (41%) |
| Any surgical intervention for elevated IOP | 5 (2%) | 2 (2%) |
Figure 1: Mean IOP During the Studies
 |
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Yutiq (Fluocinolone Acetonide Intravitreal Implant)
© Yutiq Patient Information is supplied by Cerner Multum, Inc. and Yutiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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