OZURDEX- dexamethasone implant

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Disponibil de la:

Allergan, Inc.

INN (nume internaţional):

dexamethasone

Compoziție:

dexamethasone 0.7 mg

Calea de administrare:

INTRAVITREAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

OZURDEX ®   (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). OZURDEX ®   is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. OZURDEX ®   is indicated for the treatment of diabetic macular edema.   OZURDEX ®   (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.  OZURDEX ® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. OZURDEX ® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX ® use. OZURDEX ® is contraindicated in patients with known hypersensitivity to any components of this product [see Adverse Reactions ( 6 )] . Risk Summary There are no adequate and well-controlled studies with OZURDEX ® in pregnant women. Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of the abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than the recommended human ophthalmic dose (RHOD) of OZURDEX ® (0.7 milligrams dexamethasone), respectively. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. A dose of 0.75 mg/kg/day in the mouse is approximately 5 times an OZURDEX ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.20 mg/kg/day, on gestational day 6 followed by 0.13 mg/kg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an OZURDEX ® injection in humans (0.7 mg dexamethasone) on a mg/m2 basis. A no-observed-adverse-effect-level (NOAEL) was not identified in the mouse or rabbits studies. Risk Summary Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production or cause other unwanted effects. There is no information regarding the presence of dexamethasone in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of OZURDEX ® to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with  the mother’s clinical need for OZURDEX ® and any potential adverse effects on the breastfed child from OZURDEX ® . Safety and effectiveness of OZURDEX ® in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Rezumat produs:

OZURDEX ®   (dexamethasone intravitreal implant) 0.7 mg is supplied in a foil pouch with 1 single-use plastic applicator, NDC 0023-3348-07. Storage: Store at 15o C to 30o C (59o F to 86o F).

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

OZURDEX- DEXAMETHASONE IMPLANT
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OZURDEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OZURDEX .
OZURDEX (DEXAMETHASONE INTRAVITREAL IMPLANT),
FOR INTRAVITREAL INJECTION
INITIAL U.S. APPROVAL: 1958
INDICATIONS AND USAGE
OZURDEX is a corticosteroid indicated for:
The treatment of macular edema following branch retinal vein occlusion
(BRVO) or central retinal vein
occlusion (CRVO) (1.1)
The treatment of non-infectious uveitis affecting the posterior
segment of the eye (1.2)
The treatment of diabetic macular edema (1.3)
DOSAGE AND ADMINISTRATION
For ophthalmic intravitreal injection. (2.1)
The intravitreal injection procedure should be carried out under
controlled 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
Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR
solid polymer drug delivery
system. (3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Glaucoma (4.2)
Torn or ruptured posterior lens capsule (4.3)
Hypersensitivity (4.4)
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)
ADVERSE REACTIONS
In controlled studies, the most common adverse reactions reported by
20–70% of patients were cataract,
increased intraocular pressure and conjunctival hemorrhage. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ABBVIE AT
1-800-678-1605 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.