JETREA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JETREA (JETREA).
Ocriplasmin is a recombinant truncated form of human plasmin that cleaves fibronectin, laminin, and collagen, thereby dissolving the vitreoretinal adhesion responsible for vitreomacular traction.
| Metabolism | Ocriplasmin is a proteolytic enzyme that undergoes autolysis and degradation into smaller peptides and amino acids; specific CYP involvement not established. |
| Excretion | Primarily via proteolytic catabolism; renal excretion of intact drug negligible due to size; no significant biliary or fecal elimination reported. |
| Half-life | Approximately 3.9 hours (range 2.8–5.2 h) from vitreous; systemic half-life not measured but negligible due to low systemic exposure. |
| Protein binding | Not determined; expected to be low due to small molecular weight and high hydrophilicity. |
| Volume of Distribution | Restricted primarily to vitreous humor; systemic distribution minimal; Vd not applicable for systemic circulation; estimated vitreal volume ~4 mL. |
| Bioavailability | Intravitreal injection: 100% bioavailability locally; systemic exposure negligible (< 0.1% of injected dose). |
| Onset of Action | Intravitreal injection: Clot dissolution begins within 24–48 hours; peak effect on vitreomacular adhesion release observed by day 7. |
| Duration of Action | Single intravitreal dose: Pharmacodynamic effect persists for at least 28 days; vitreomacular adhesion release typically sustained; retreatment may be considered after 4 weeks if needed. |
Intravitreal injection of 0.5 mg (0.1 mL of 5 mg/mL solution) once, with potential repeat administration at least 4 weeks after initial injection.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment; pharmacokinetics not altered in renal dysfunction. |
| Liver impairment | No dose adjustment required for hepatic impairment; safety and efficacy not studied in severe hepatic disease. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no specific weight-based dosing guidelines available. |
| Geriatric use | No specific dose adjustment needed; elderly patients may have increased risk of intraocular inflammation, but dosing same as adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JETREA (JETREA).
| Breastfeeding | No data on presence in human milk or effects on breastfed infant. Due to negligible systemic absorption, transfer into breast milk is unlikely. M/P ratio not available. Caution recommended. |
| Teratogenic Risk | JETREA (ocriplasmin) is a recombinant protease; systemic exposure following intravitreal injection is negligible. No human pregnancy data exist. Animal studies show no teratogenicity at doses >1000x clinical exposure. Risk in all trimesters is considered minimal due to lack of systemic absorption. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to ocriplasmin or any excipients","Active ocular infection (suspected or confirmed)","Prior vitrectomy in the study eye","Retinal detachment in study eye"]
| Precautions | ["Intraocular injection associated adverse events including endophthalmitis, retinal detachment, and intraocular hemorrhage","Decreased vision and development of vitreous floaters","Risk of lens subluxation or dislocation","Emergent increased intraocular pressure","Posterior capsule opacification"] |
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| No specific fetal monitoring required. Post-injection monitoring for maternal intraocular pressure, retinal tears, or vitreous hemorrhage. Standard prenatal care. |
| Fertility Effects | No studies on fertility. Systemic exposure negligible; unlikely to affect fertility. |