DURYSTA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DURYSTA (DURYSTA).
Prostaglandin analog; selective FP receptor agonist that increases uveoscleral outflow of aqueous humor.
| Metabolism | Hydrolyzed in the cornea by esterases; further metabolism via beta-oxidation and conjugation in the liver; CYP not majorly involved. |
| Excretion | Minimal systemic absorption; no data on specific routes of elimination; expected to be primarily excreted via renal and biliary routes in small amounts. |
| Half-life | Not applicable due to local ocular administration with minimal systemic exposure; bimatoprost systemic half-life is approximately 45 minutes after intravenous administration. |
| Protein binding | Approximately 88% bound to human plasma proteins (primarily albumin) for bimatoprost. |
| Volume of Distribution | 0.7 L/kg for bimatoprost after systemic administration, indicating distribution into total body water; however, DURYSTA is administered locally, so systemic Vd is not clinically relevant. |
| Bioavailability | Systemic bioavailability is negligible after intracameral administration due to low dose and local metabolism. |
| Onset of Action | Reduction in intraocular pressure (IOP) begins within 1-2 hours after intracameral administration, with peak IOP reduction at 12-18 hours. |
| Duration of Action | Sustained IOP reduction for up to 3-4 months following a single intracameral injection; duration may vary by patient and IOP target. |
One intracameral implant (10 mcg) administered in the study eye by a qualified ophthalmologist. A second administration may be performed if necessary, at least 3 months after the initial implant.
| Dosage form | IMPLANT |
| Renal impairment | No dosage adjustment required based on renal impairment. |
| Liver impairment | No dosage adjustment required based on hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients. Use not recommended. |
| Geriatric use | No specific dosage adjustment recommended in elderly patients. Clinical studies included patients aged 65 years and older with no overall differences in safety or efficacy observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DURYSTA (DURYSTA).
| Breastfeeding | No data on presence in human milk, effects on breastfed infant, or milk production. Other bimatoprost formulations are present in breast milk; caution advised. |
| Teratogenic Risk | No human data; in animal studies, intravitreal bimatoprim implant (DURYSTA) showed no teratogenicity but did produce embryofetal toxicity at maternally toxic doses. Risk cannot be excluded; use only if benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to bimatoprost or any component of the formulation","Active herpes simplex keratitis","Contraindicated in patients with previous history of herpetic keratitis (relative)"]
| Precautions | ["Pigmentation of the iris, periorbital tissue, and eyelashes","Eyelash changes (length, thickness, number)","Cystoid macular edema in aphakic/pseudophakic patients with torn posterior lens capsule","Bacterial keratitis from contaminated single-dose containers","Concomitant use with other prostaglandin analogs may increase IOP","Use with caution in patients with history of intraocular inflammation (iritis/uveitis)"] |
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| Monitor intraocular pressure and ocular adverse events. No specific fetal monitoring required unless maternal condition warrants. |
| Fertility Effects | No human data. In animal studies, no effects on fertility were observed. |