JETREA

Other Ophthalmologicals, Topical

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution is clear and colorless. Discard vial if solution is discolored or if particulate matter is present.

Intravitreal Administration
Ocriplasmin should only be administered by a qualified physician.
Each vial should only be used to provide a single injection for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needles should be changed before administration to the other eye. However, treatment with ocriplasmin in the other eye is not recommended within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye.
Instruct patients to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurred or decreased vision) without delay.
Repeated administration of ocriplasmin in the same eye is not recommended.
Reconstitution (2.5 mg/mL vial corresponding to 0.5 mg):
Remove the vial from the freezer and allow to thaw at room temperature (within a few minutes). Once completely thawed, remove the cap from the vial and disinfect with an alcohol wipe.
Using aseptic technique, add 0.2 mL of 0.9% w/v Sodium Chloride Injection, USP (sterile, preservative-free) into the ocriplasmin vial and gently swirl the vial until the solutions are mixed.
 
Intravitreal injection:
Using aseptic technique, withdraw all of the solution using a sterile 19-gauge needle and discard the needle after withdrawal of the vial contents. Do not use this needle for the intravitreal injection.
Replace the needle with a sterile 30-gauge needle, expel air bubbles and excess drug from the syringe, and adjust the dose to the 0.1 mL (0.125 mg ocriplasmin) mark on the syringe.
Use the solution immediately as it contains no preservatives.
Under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad spectrum microbicide should be administered according to standard medical practice.
Insert the injection needle 3.5 to 4 mm posterior to the limbus aiming towards the center of the vitreous cavity, avoiding the horizontal meridian. The injection volume of 0.1 mL is then delivered into the mid-vitreous.
Monitor patients immediately after the injection for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. A sterile paracentesis needle should be available if required.
Discard any unused portion after injection.

retinal edema / Delayed / 5.0-20.0
visual impairment / Early / 5.6-5.6
macular edema / Delayed / 0-5.0
ocular hypertension / Delayed / 4.1-4.1
ocular hemorrhage / Delayed / 2.4-2.4
retinal detachment / Delayed / 0.9-0.9
night blindness / Delayed / Incidence not known
lens subluxation / Delayed / Incidence not known

photopsia / Delayed / 5.0-20.0
blurred vision / Early / 5.0-20.0
ocular inflammation / Early / 7.1-7.1
cataracts / Delayed / 0-5.0
iritis / Delayed / 0-5.0
conjunctival hyperemia / Early / 0-5.0
photophobia / Early / 0-5.0
dyschromatopsia / Delayed / 2.0-2.0
ocular infection / Delayed / Incidence not known

ocular pain / Early / 5.0-20.0
ocular irritation / Rapid / 0-5.0
xerophthalmia / Early / 0-5.0

JETREA

Rx

Intravitreal proteolytic enzyme
Approved for symptomatic vitreomacular adhesions
Adverse effects are related to drug administration or visual changes (changes in color or acuity)

0.125 mg (0.1 mL of the solution) by intravitreal injection to the affected eye once as a single dose. Repeated administration in the same eye is not recommended. Treatment of the contralateral eye is not recommended within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye. In 2 clinical studies, a significantly higher proportion of patients treated with ocriplasmin achieved resolution of vitreomacular adhesion (VMA) at day 28 compared with vehicle through month 6. In addition, the percentage of patients achieving total posterior vitreous detachment (PVD) was statistically significantly higher at day 28 in the ocriplasmin group compared to vehicle in both studies (16% vs. 6%; p = 0.014 and 11% vs. 0%; p < 0.01). The number of patients with at least 3 lines increase in visual acuity was numerically higher in the ocriplasmin group compared to vehicle in both trials; however, the number of patients with at least 3 lines decrease in visual acuity was also higher in the ocriplasmin group in 1 of the studies.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Ocriplasmin products.

JETREA/Ocriplasmin Intravitreal Inj Sol: 1mL, 1.25mg, 2.5mg

0.125 mg single dose monocular.

0.125 mg single dose monocular.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Ocriplasmin is a proteolytic enzyme with activity against protein components of the vitreous body and the vitreoretinal interface (e.g.,  laminin, fibronectin and collagen). Ocriplasmin dissolves the protein matrix responsible for vitreomacular adhesions.

Ocriplasmin is administered via intravitreous injection. Such administration allows only minimal systemic exposure. Detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.

Intravitreous Route
Mean ocriplasmin activity levels in vitreous samples are 12 +/- 7.6 mcg/ml 5—30 minutes after a 0.125 mg intravitreous injection. At 24 hours post-injection, levels in the vitreous were below 3% of the theoretical concentration reached immediately after injection. Ocriplasmin is rapidly inactivated via interactions with protease inhibitor alpha 2-antiplasmin or alpha 2-macroglobulin in the endogenous protein catabolism pathway.

Ocriplasmin is classified in FDA pregnancy category C. It is not known whether ocriplasmin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with ocriplasmin. There are no adequate and well-controlled studies of ocriplasmin in pregnant women. However, the systemic exposure to ocriplasmin is expected to be low after intravitreal injection of a single 0.125 mg dose. Assuming 100% systemic absorption (and a plasma volume of 2700 mL), the estimated plasma concentration is 46 ng/mL. According to the manufacturer, ocriplasmin should be given to a pregnant woman only if clearly needed.

According to the manufacturer, caution should be exercised when ocriplasmin is administered to a breast-feeding mother. It is not known whether ocriplasmin is excreted in human milk.