DURYSTA- bimatoprost implant

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BIMATOPROST (UNII: QXS94885MZ) (BIMATOPROST - UNII:QXS94885MZ)

Disponível em:

Allergan, Inc.

Via de administração:

INTRACAMERAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

DURYSTA®  (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections. DURYSTA is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy) [see Warnings and Precautions ( 5.1 ) ]. DURYSTA is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants [e.g., Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK)]. DURYSTA is contraindicated in patients whose posterior lens capsule is absent or ruptured, due to the risk of implant migration into the posterior segment. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for DURYSTA use if the intraocular lens fully covers the opening in the posterior capsule. DURYSTA is contraindicated in patients with hypersensitivity to bimatoprost or to any other components of the product [see Adverse Reactions ( 6.1 ) ]. Risk Summary There are no adequate and well-controlled studies of DURYSTA (bimatoprost intracameral implant) administration in pregnant women to inform a drug associated risk. Oral administration of bimatoprost to pregnant rats and mice throughout organogenesis did not produce adverse maternal or fetal effects at clinically relevant exposures. Oral administration of bimatoprost to rats from the start of organogenesis to the end of lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant exposures [see Animal Data] .  Data Animal Data In an embryofetal development rat study, oral administration of bimatoprost to pregnant rats during organogenesis produced abortion at 0.6 mg/kg/day (1770-times the human systemic exposure to bimatoprost from DURYSTA, based on Cmax and a blood-to plasma partition ratio of 0.858). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 470-times the human systemic exposure to bimatoprost from DURYSTA, based on Cmax ). No fetal abnormalities were observed at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, oral administration of bimatoprost to pregnant mice during organogenesis produced abortion and early delivery at 0.3 mg/kg/day (2240-times the human systemic exposure to bimatoprost from DURYSTA, based on plasma Cmax level; blood-to plasma partition ratio of 0.858). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (400-times the human systemic exposure to bimatoprost from DURYSTA, based on Cmax ). No fetal abnormalities were observed at doses up to 0.6 mg/kg/day (5200-times the human systemic exposure to bimatoprost from DURYSTA, based on Cmax ). In a pre/postnatal development study, oral administration of bimatoprost to pregnant rats from gestation day 7 through lactation resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at 0.3 mg/kg/day (estimated 470-times the human systemic exposure to bimatoprost from DURYSTA, based plasma Cmax and a blood-to plasma partition ratio of 0.858). No adverse effects were observed in rat offspring at 0.1 mg/kg/day (estimated 350-times the human systemic exposure to bimatoprost from DURYSTA, based on plasma Cmax ). Risk Summary There is no information regarding the presence of bimatoprost in human milk, the effects on the breastfed infants, or the effects on milk production. In animal studies, topical bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when DURYSTA is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for DURYSTA and any potential adverse effects on the breastfed child from DURYSTA. Safety and effectiveness of DURYSTA in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Resumo do produto:

DURYSTA contains a 10 mcg bimatoprost intracameral implant in a single-use applicator that is packaged in a sealed foil pouch containing desiccant, NDC 0023-9652-01. Storage Store refrigerated at 2°C to 8°C (36°F to 46°F).

Status de autorização:

New Drug Application

Características técnicas

DURYSTA- BIMATOPROST IMPLANT
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DURYSTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DURYSTA.
DURYSTA (BIMATOPROST INTRACAMERAL IMPLANT), FOR INTRACAMERAL
ADMINISTRATION
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
DURYSTA is a prostaglandin analog indicated for the reduction of
intraocular pressure (IOP) in patients with
open angle glaucoma (OAG) or ocular hypertension (OHT). (1)
DOSAGE AND ADMINISTRATION
For ophthalmic intracameral administration. (2.1)
The intracameral administration should be carried out under standard
aseptic conditions. (2.2)
DOSAGE FORMS AND STRENGTHS
Intracameral implant containing bimatoprost 10 mcg, in a drug delivery
system. (3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Corneal endothelial cell dystrophy (4.2)
Prior corneal transplantation (4.3)
Absent or ruptured posterior lens capsule (4.4)
Hypersensitivity (4.5)
WARNINGS AND PRECAUTIONS
Endothelial cell loss: Due to possible corneal endothelial cell loss,
administration of DURYSTA should be
limited to a single implant per eye without retreatment. (5.1)
Corneal Adverse Reactions: DURYSTA has been associated with corneal
adverse reactions and risks are
increased with multiple implants. Use caution in patients with limited
corneal endothelial cell reserve.
(5.1)
Iridocorneal Angle: DURYSTA should be used with caution in patients
with narrow angles or anatomical
angle obstruction. (5.2)
ADVERSE REACTIONS
In controlled studies, the most common ocular adverse reaction
reported by 27% of patients was
conjunctival hyperemia. Other common adverse reactions reported in
5-10% of patients were foreign body
sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye,
eye irritation, intraocular pressure
increased, corneal endothelial cell loss, vision blurred, iritis, and
headache. (6.1)
_ _
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ABBVIE AT
1-800-678-1605 OR FDA AT 1-
800-