YUTIQ .18 mg/1

FLUOCINOLONE ACETONIDE · IMPLANT · ANI Pharmaceuticals, Inc.

No Recall History

Plain English

YUTIQ is a implant containing fluocinolone acetonide at .18 mg/1, taken intravitreal. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name: YUTIQ
Generic Name: FLUOCINOLONE ACETONIDE
NDC Code (Product): 68611-180
Manufacturer: ANI Pharmaceuticals, Inc.
Strength: .18 mg/1
Dosage Form: IMPLANT
Route: INTRAVITREAL
Marketing Status
Application #: NDA210331
Drug Class: Corticosteroid [EPC]
Marketing Start: 05/17/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use505 reports

product dose omission issue195 reports

drug ineffective170 reports

pruritus147 reports

rash131 reports

no adverse event129 reports

diarrhoea113 reports

psoriasis90 reports

fatigue86 reports

headache85 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ contains a corticosteroid and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. ( 1 )

Dosage & Administration

2. DOSAGE AND ADMINISTRATION For ophthalmic intravitreal injection. ( 2.1 ) The intravitreal injection procedure should be carried out under aseptic conditions. ( 2.2 ) Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. ( 2.2 ) 2.1. General Dosing Information For ophthalmic intravitreal injection. 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 YUTIQ is as follows: Just prior to injection, administer topical and/or subconjunctival anesthesia at the injection site (inferotemporal quadrant recommended). Administer 2-3 drops of a broad-spectrum microbicide into the lower fornix. The lids may be scrubbed with cotton-tipped applicators soaked with a broad-spectrum microbicide. Place a sterile lid speculum. Have the patient look up and apply additional microbicide solution to the injection site. Allow 30-60 seconds fo…

Contraindications

4. CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1. Ocular or Periocular Infections YUTIQ is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. 4.2. Hypersensitivity YUTIQ is contraindicated in patients with known hypersensitivity to any components of this product.

Adverse Reactions

6. ADVERSE REACTIONS In controlled studies, the most common adverse reactions reported were cataract development and increases in intraocular pressure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alimera Sciences, Inc. at 1-844-445-8843 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1. 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 …

Frequently Asked Questions

What is YUTIQ used for?

YUTIQ contains FLUOCINOLONE ACETONIDE. It is a implant taken intravitreal. Consult your doctor for specific uses.

Is YUTIQ a controlled substance?

YUTIQ is not classified as a controlled substance by the DEA.

What is the generic name for YUTIQ?

The generic name for YUTIQ is FLUOCINOLONE ACETONIDE. There are 11 other brand versions of FLUOCINOLONE ACETONIDE.

What is the NDC code for YUTIQ .18 mg/1?

The NDC (National Drug Code) for YUTIQ .18 mg/1 is 68611-180, listed by ANI Pharmaceuticals, Inc..

Product NDC

68611-180

Package NDC

68611-180-01

Other Fluocinolone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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