Dosing and uses of Jetrea (ocriplasmin intravitreal)
Adult dosage forms and strengths
intravitreal solution
- 0.5mg/0.2mL (undiluted solution)
Vitreomacular Adhesion
Proteolytic enzyme indicated for treatment of symptomatic vitreomacular adhesion
0.125 mg (0.1 mL of diluted solution) by intravitreal injection to affected eye once as a single injection (see Administration)
Administration
Must dilute before use
For single use ophthalmic intravitreal injection only
Each vial should only be used to provide a single injection for the treatment of a single eye; if contralateral eye requires treatment, a new vial should be used and the sterile filed, syringe, gloves, drapes, eyelid speculum, injection needles should be changed
Repeated injection in the same eye not recommended
Intravitreal injection preparation
- Remove vial (2.5 mg/mL corresponding to 0.5 mg ocriplasmin) from the freezer and allow to thaw to room temperature (within a few minutes)
- Once completely thawed, remove the protective flip-off cap from vial and disinfect vial top with alcohol wipe
- Using aseptic technique, add 0.2 mL of 0.9% NaCl (sterile, preservative-free injection) to vial and gently swirl until solutions are mixed
- Visually inspect vial for particulate matter; use only if clear, colorless solution without visible particles
- Withdraw all diluted solution using 19-gauge needle and discard needle after vial contents withdrawn (do not use needle used to withdraw drug for intravitreal injection)
- Replace need with 30-gauge needle, carefully expel air bubbles and excess drug from the syringe and adjust the dose to the 0.1 mL mark on the syringe (ie, 0.125 mg ocriplasmin)
- Use solution immediately (contains no preservatives)
- Discard vial and any unused portion of the diluted solution after single use
Pediatric dosage forms and strengths
Safety and efficacy not established; use in children not recommended
Vitrectomy clinical trial results described within the prescribing information found no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints or adverse events (24 eyes of 22 pediatric patients)
Jetrea (ocriplasmin intravitreal) adverse (side) effects
>10%
Conjunctival hemorrhage (17.4%)
Vitreous floaters (16.6%)
Eye pain (12.3%)
1-10%
Photopsia (9%)
Increased IOP (8.8%)
Macular hole (7.6%)
Intraocular inflammation (7.1%)
Blurred vision (6.7%)
Macular edema (4.3%)
Decreased vision acuity (5.7%)
Retinal edema (4.3%)
Photophobia (3.4%)
Intraocular hemorrhage (2.4%)
Dyschromatopsia (2%)
Vitreous detachment (1.9%)
Retinal tear (without detachment) (1.1%)
Electroretinographic changes (1%)
<1%
Lens subluxation
Retinal detachment
Postmarketing Reports
Night blindness
Warnings
Contraindications
None
Cautions
Decrease of ≥3 line BCVA; these decreases in vision were due to progression of the condition and many required surgical intervention
Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased IOp
Potential for lens subluxation
Retinal breaks (eg, detachment, tear) reported
Dyschromatopsia (yellowish vision) and electroretinographic changes (a- and b-wave amplitude decreases) reported
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk; caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Jetrea (ocriplasmin intravitreal)
Mechanism of action
Elicits proteolytic activity against protein components within the vitreous body and vitreoretinal interface (eg, laminin, fibronectin, collagen), thereby dissolving the protein matrix responsible for vitreomacular adhesion
Absorption
0.125 mg dose corresponds to 29 mcg/mL vitreous volume
Detectable systemic levels not expected
Vitreous levels: 12 mcg/mL (within 30 min post injection); 0.5 mcg/mL (24 hr post injection)
Metabolism
Enters endogenous protein catabolism pathway and is rapidly inactivated via interactions with protease inhibitor alpha2-antiplasmin or alpha2-macroglobulin
