RETISERT- fluocinolone acetonide implant

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Bausch & Lomb Incorporated

Designación común internacional (DCI):

FLUOCINOLONE ACETONIDE

Composición:

FLUOCINOLONE ACETONIDE 0.59 mg

Vía de administración:

INTRAVITREAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

RETISERT ® is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye. No adequate animal reproduction studies have been conducted with fluocinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Fluocinolone acetonide when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000 times the daily clinical dose of RETISERT), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the third and at the beginning of the fourth gestational week. When administered subcutaneously to rats and rabbits during gestation at a maternal toxic dose of 50 mcg/kg/day (approximately 4,000 times the clinical dose of RETISERT), fluocinolone acetonide caused abortions and malformations in a few surviving fetuses. There are no adequate and well-controlled studies in pregnant women. RETISERT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when RETISERT is implanted in a nursing woman. Safety and effectiveness in pediatric patients below the age of 12 years have not been established. No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Resumen del producto:

The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive. Each RETISERT ® is approximately 3 mm x 2 mm x 5 mm. Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap. Each packaged implant is provided in a carton which includes the prescribing information. NDC 24208-416-01           0.59 mg            1 count Storage: Store in the original container at 15°C to 25°C (59°F to 77°F). Protect from freezing.

Estado de Autorización:

New Drug Application

Ficha técnica

RETISERT- FLUOCINOLONE ACETONIDE IMPLANT
BAUSCH & LOMB INCORPORATED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RETISERT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RETISERT.
RETISERT
(FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT) 0.59 MG, FOR
INTRAVITREAL USE
INITIAL U.S. APPROVAL: 1963
INDICATIONS AND USAGE
RETISERT is a corticosteroid indicated for the treatment of chronic
non-infectious uveitis affecting the
posterior segment of the eye. (1)
DOSAGE AND ADMINISTRATION
RETISERT is surgically implanted into the posterior segment of the
affected eye through a pars plana
incision. (2.1)
RETISERT is designed to release fluocinolone acetonide at a nominal
initial rate of 0.6 mcg/day,
decreasing over the first month to a steady state between 0.3-0.4
mcg/day over approximately 30
months. (2.1)
Aseptic technique should be maintained at all times prior to and
during the surgical implantation
procedure. (2.2)
DOSAGE FORMS AND STRENGTHS
0.59 mg fluocinolone acetonide intravitreal implant. ( 3)
CONTRAINDICATIONS
Surgical placement of RETISERT is contraindicated in active viral,
bacterial, mycobacterial and fungal
infections of ocular structures. (4.1)
WARNINGS AND PRECAUTIONS
Cataract formation: Nearly all phakic patients are expected to develop
cataracts and require cataract
surgery. (5.1)
Endophthalmitis: Late onset endophthalmitis has been observed. (5.2)
Increase in intraocular pressure: Use of corticosteroids may result in
elevated IOP and/or glaucoma.
(5.3)IOP lowering medications were required in > 75% of patients;
filtering surgeries were required in >
35% of patients. (6.1)
Separation of implant components: Physicians should periodically
monitor the integrity of the implant
by visual inspection. (5.4)
ADVERSE REACTIONS
Ocular adverse events included procedural complications, and eye pain
(> 50%). Thirty-five to forty
percent of patients reported ocular/conjunctival hyperemia, reduced
visual acuity, and conjunctival
hemorrhage. (