Label: DURYSTA- bimatoprost implant
- NDC Code(s): 0023-9652-01, 0023-9652-03
- Packager: Allergan, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 16, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DURYSTA safely and effectively. See full prescribing information for DURYSTA. DURYSTA® (bimatoprost intracameral implant) ...
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Table of ContentsTable of Contents
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1
INDICATIONS AND USAGE
DURYSTA® (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
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2
DOSAGE AND ADMINISTRATION
2.1 - General Information - DURYSTA is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. DURYSTA should not be readministered to an ...
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3
DOSAGE FORMS AND STRENGTHS
Intracameral implant containing 10 mcg of bimatoprost in a drug delivery system.
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4
CONTRAINDICATIONS
4.1 - Ocular or Periocular Infections - DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections. 4.2 - Corneal Endothelial Cell ...
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5
WARNINGS AND PRECAUTIONS
5.1 - Corneal Adverse Reactions - The presence of DURYSTA implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration ...
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6
ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling: Implant migration [see Contraindications (4.4)] Hypersensitivity [see Contraindications ...
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USE IN SPECIFIC POPULATIONS
8.1 - Pregnancy - Risk Summary - There are no adequate and well-controlled studies of DURYSTA (bimatoprost intracameral implant) administration in pregnant women to inform a drug ...
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DESCRIPTION
DURYSTA is a sterile intracameral implant containing 10 mcg of bimatoprost, a prostaglandin analog, in a solid polymer sustained-release drug delivery system (DDS). The drug delivery system ...
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CLINICAL PHARMACOLOGY
12.1 - Mechanism of Action - Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. Bimatoprost is believed to lower IOP ...
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NONCLINICAL TOXICOLOGY
13.1 - Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses up to ...
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14
CLINICAL STUDIES
Efficacy was evaluated in two multicenter, randomized, parallel-group, controlled 20-month (including 8-month extended follow-up) studies of DURYSTA compared to twice daily topical timolol 0.5 ...
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HOW SUPPLIED/STORAGE AND HANDLING
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 ...
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PATIENT COUNSELING INFORMATION
Treatment-related Effects - Advise patients about the potential risk for complications including, but not limited to, the development of corneal adverse events, intraocular inflammation or ...
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PRINCIPAL DISPLAY PANEL
NDC 0023-9652-01 - DURYSTA® (bimatoprost intracameral implant) 10 mcg - One Sterile, Single-Dose Applicator - For Intracameral administration - Rx only
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INGREDIENTS AND APPEARANCEProduct Information