JETREA® is a proteolytic enzyme indicated for the
treatment of symptomatic vitreomacular adhesion.
DOSAGE AND ADMINISTRATION
General Dosing Information
For single-use ophthalmic intravitreal injection only.
JETREA must only be administered by a qualified physician.
This formulation of JETREA does not require dilution.
The recommended dose is 0.125 mg (0.1 mL of the solution)
administered by intravitreal injection to the affected eye once as a single
Preparation For Administration
To prepare JETREA for intravitreal injection, adhere to
the following instructions:
1. Remove the vial (1.25 mg/mL corresponding to 0.375 mg
ocriplasmin) from the freezer and allow to thaw at room temperature (within a
few minutes). Use JETREA immediately after thawing. Unopened vials in the
original carton protected from light can be stored up to 8 hours when stored
below 77°F (25°C). Do not refreeze a vial once it has been thawed.
2. Once completely thawed, remove the protective
polypropylene blue flip-off cap from the vial (see Figure 1).
3. The top of the vial should be disinfected with an
alcohol wipe (see Figure 2).
4. Visually inspect the vial for particulate matter. Only
a clear, colorless solution without visible particles should be used.
5. Using aseptic technique, withdraw all of the solution
using a sterile #19 gauge needle (slightly tilt the vial to ease withdrawal)
and discard the needle after withdrawal of the vial contents (see Figure 3). Do
not use this needle for the intravitreal injection.
6. Replace the needle with a sterile #30 gauge needle,
carefully expel the air bubbles and excess drug from the syringe and adjust the
dose to the 0.1 mL mark on the syringe (corresponding to 0.125 mg ocriplasmin) (see
7. THE SOLUTION SHOULD BE USED IMMEDIATELY AS IT CONTAINS
8. Discard the vial and any unused portion of the
solution after single use.
Administration And Monitoring
The intravitreal injection procedure should be carried
out under controlled aseptic conditions, which include the use of sterile
gloves, a sterile drape and a sterile eyelid speculum (or 5 equivalent).
Adequate anesthesia and a broad spectrum microbiocide should be administered
according to standard medical practice.
The injection needle should be inserted 3.5 - 4.0 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.
Immediately following the intravitreal injection,
patients should be monitored for elevation in intraocular pressure. Appropriate
monitoring may consist of a check for perfusion of the optic nerve head or
tonometry. If required, a sterile paracentesis needle should be available.
Following intravitreal injection, patients should be
instructed 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 [see PATIENT INFORMATION].
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 JETREA
is administered to the other eye, however, treatment with JETREA 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.
Repeated administration of JETREA in the same eye is not
recommended [see Nonclinical Toxicology].
After injection, any unused product must be discarded.
No special dosage modification is required for any of the
populations that have been studied (e.g. gender, elderly).
Dosage Forms And Strengths
Injection: Single-use glass vial containing JETREA 0.375
mg in 0.3 mL solution for intravitreal injection (1.25 mg/mL).
Storage And Handling
Each vial of JETREA contains 0.375 mg ocriplasmin in 0.3
mL preservative-free, citric-buffered solution (1.25 mg/mL). JETREA is supplied
in a 2 mL glass vial with a blue polypropylene flip-off cap. The vial stopper
is not made with natural rubber latex. Vials are for single use only.
Store frozen at or below -4°F (-20°C). Protect
the vials from light by storing in the original package until time of use. 13
Manufactured by: ThromboGenics, Inc., 101 Wood Avenue
South, Suite 610, Iselin, NJ 08830. Revised : Feb 2017