ILUVIEN- fluocinolone acetonide implant

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Disponível em:

Alimera Sciences, Inc.

DCI (Denominação Comum Internacional):

FLUOCINOLONE ACETONIDE

Composição:

FLUOCINOLONE ACETONIDE 0.19 mg

Via de administração:

INTRAVITREAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg 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. ILUVIEN 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. ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product. Pregnancy Category C There are no adequate and well-controlled studies of ILUVIEN in pregnant women. Animal reproduction studies have not been conducted with fluocinolone acetonide. Corticosteroids have been shown to be teratogenic in labor

Resumo do produto:

ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is supplied in a sterile single use preloaded applicator with a 25-gauge needle, packaged in a tray sealed with a lid inside a carton. NDC 68611-190-02 Storage: Store at 15° - 30° C (59° - 86° F).

Status de autorização:

New Drug Application

Características técnicas

ILUVIEN- FLUOCINOLONE ACETONIDE IMPLANT
ALIMERA SCIENCES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ILUVIEN® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ILUVIEN.
ILUVIEN® (FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT)
0.19 MG
FOR INTRAVITREAL INJECTION
INITIAL U.S. APPROVAL: 1963
INDICATIONS AND USAGE
ILUVIEN contains a corticosteroid and 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. (1)
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)
DOSAGE FORMS AND STRENGTHS
Non-bioerodable intravitreal implant containing 0.19 mg fluocinolone
acetonide in a drug delivery system.
(3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Glaucoma (4.2)
Hypersensitivity (4.3)
WARNINGS AND PRECAUTIONS
Intravitreal injections have been associated with endophthalmitis, eye
inflammation, increased
intraocular pressure, and retinal detachments. Patients should be
monitored following the injection.
(5.1)
Use of corticosteroids may produce posterior subcapsular cataracts,
increased intraocular pressure,
glaucoma, and may enhance the establishment of secondary ocular
infections due to bacteria, fungi, or
viruses. (5.2)
The implant may migrate into the anterior chamber if the posterior
lens capsule is not intact. (5.3)
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.
SEE 17 FOR PATIENT COUNSEL