Jetrea - Consumer Medicine Information
|Class:||Miscellaneous ophthalmic agents|
|Form:||Liquid solution, Eye drops (ophthalmic)|
|Ingredients:||ocriplasmin, citric acid, mannitol, sodium hydroxide and water|
About this Medication
What the medication is used for
JETREA is a concentrate for solution for injection. After dilution, it is injected into the eye.
JETREA is used to treat adults with an eye condition called symptomatic vitreomacular adhesion (VMA).
VMA is caused by persistent vitreous (jelly like material in the back of the eye) attachment to the macula (centre of the light sensitive layer in the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMA can cause symptoms such as distorted or decreased vision. When the condition progresses the adhesion may cause traction, which may eventually result in the formation of a hole in the macula (called macular hole).
What it does
JETREA works by separating the vitreous humour from the macula.
When it should not be used
JETREA should not be used if you are allergic to ocriplasmin or any of the other ingredients of this medicine or if you have or are suspected of having an infection in or around your eye.
What the medicinal ingredient is
The medicinal ingredient in JETREA is ocriplasmin.
What the important nonmedicinal ingredients are
The nonmedicinal ingredients are: citric acid, mannitol, sodium hydroxide and water.
What dosage forms it comes in
JETREA is a solution for intravitreal injection after dilution. JETREA is supplied in a glass vial with a latex-free rubber stopper. Each vial contains 0.5 mg of ocriplasmin in 0.2 mL of solution. After dilution with 0.2 mL of 0.9% w/v sodium chloride, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Warnings and Precautions
BEFORE you use JETREA talk to your doctor or pharmacist if:
- you have or have had any eye conditions or eye treatments.
- you have any allergies to this drug or its ingredients or components of the container.
JETREA is administered as an injection into the eye. Your doctor/ophthalmologist will monitor you in case you develop an infection or any complications after the injection. You should contact your doctor/ophthalmologist immediately if you develop any of the eye symptoms described in section 4 ‘Possible side effects’, after an injection of JETREA.
Driving and using machines
JETREA can cause side effects that may impair your vision. Do not drive or use machines until your vision is clear.
Interactions with this Medication
Tell your doctor/ophthalmologist if you are taking, have recently taken or might take any other medicines. Inform your doctor/ ophthalmologist if you have had an injection of a medicine into the eye recently. This information will be taken into account to evaluate if and when JETREA can be injected into the same eye.
Proper Use of this Medication
You will not be administered JETREA into both eyes at the same time.
You will not be administered JETREA more than once into the same eye.
If an overdose occurs, your doctor/ophthalmologist will monitor you.
Side Effects and what to do about them
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms after an injection with JETREA. Your doctor/ophthalmologist will monitor you and take corrective measures if needed.
- A severe decrease in vision
- This has been reported in up to 1 in 10 patients within one week after JETREA treatment. This is generally reversible and will usually disappear within two weeks.
- Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, increased sensitivity to light or increased number of dark floating spots in the field of vision (floaters) are also seen in up to 1 in 10 patients.
- These may be the signs of an infection, bleeding, separation or tear of the retina or an increase in the pressure inside the treated eye.
- Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
This is not a complete list of side effects. For any unexpected effects while taking JETREA, contact your doctor or pharmacist.
How to Store it
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month.
Store in a freezer at -20°C±5°C. If the product is exposed to higher temperatures during storage, the vial should be discarded.
The solution should be used immediately after dilution. The vial and any unused portion of the diluted solution should be discarded after single use.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.alcon.ca or by contacting the sponsor, ALCON Canada Inc. at: 1-800-613-2245.