READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE
PATIENT MEDICATION INFORMATION
Latanoprostene bunod ophthalmic solution
Read this carefully before you start taking VYZULTA® and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about VYZULTA®.
What is VYZULTA® used for?
VYZULTA® is used to reduce the high pressure in the eye in patients with the following conditions:
- open-angle glaucoma or ocular hypertension.
How does VYZULTA® work?
VYZULTA® lowers the pressure in the eye by increasing the outflow of fluid from inside the eye.
What are the ingredients in VYZULTA®?
Medicinal ingredient: Latanoprostene Bunod
Non-medicinal ingredients: Benzalkonium Chloride (as preservative), Citric Acid, EDTA, Glycerin, Polysorbate 80, Sodium Citrate and Water.
VYZULTA® comes in the following dosage form:
As an ophthalmic solution (eye drops) containing 0.24% w/v of latanoprostene bunod (0.24 mg/mL). Available in 7.5 mL bottle with a 5 mL fill volume.
Do not use VYZULTA® if you:
- are allergic to latanoprostene bunod
- are allergic to any of the other ingredients in VYZULTA® or to a component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VYZULTA®. Talk about any health conditions or problems you may have, including if you:
- have or have had eye inflammation including the conditions iritis or uveitis.
- have or have had a torn posterior lens capsule.
- have or have had eye swelling including a condition called macular edema.
- have or have had a viral infection of the eye called herpes keratitis.
- have severe asthma or asthma that is not controlled.
- are using any other eye drops.
- notice any changes in your eyelashes or color of your eyes.
- wear contact lenses.
- are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Driving and using machines
Wait until you can see clearly before driving or operating machines after applying VYZULTA®.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take VYZULTA®:
- Apply one drop of VYZULTA® into each affected eye
- Be careful not to touch your eye, eyelids, surrounding areas, fingers or any other surface with the dropper tip of the bottle. If you do, you may contaminate the medicine and this can cause you to have an eye infection. Avoid touching the tip of the bottle.
- If you wear contact lenses, remove them before applying VYZULTA®. You may reinsert them 15 minutes after you have applied VYZULTA®.
- If your doctor has prescribed other eye drops to be taken along with VYZULTA®, apply each medicine at least 5 minutes apart.
- Use VYZULTA® exactly as your doctor has told you to. Do not apply VYZULTA® more than once a day.
The recommended dose of VYZULTA® is one drop into the affected eye(s) once daily in the evening.
If you think you have taken too much VYZULTA®, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
If you forget to use VYZULTA®, continue your treatment with the next dose the following day.
What are possible side effects from using VYZULTA®?
These are not all the possible side effects you may feel when taking VYZULTA®. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- eye irritation
- eye redness
- eye pain
- pain in your eye at the application site
- runny or stuffed nose, sore throat
- altered sense of taste
- feeling of grittiness or having something in the eye
- VYZULTA® may change colour of your eye or eyelid. The eye colour change may not be noticeable for many months to years. The eye colour and eyelid changes may be permanent. Tell your doctor if your eye colour has changed. They may examine your eyes more often.
- VYZULTA® may also cause your eyelashes to appear thicker and longer than they usually do and increase in number. Eyelash changes are reversible after treatment when VYZULTA® is stopped.
|Serious side effects and what to do about them|
|Symptom/effect||Talk to your healthcare professional||Stop taking drug and get immediate medical help|
|Only if severe||In all cases|
|RARE Bacterial keratitis (infection of the eye): eye pain or redness, decreased vision, discharge from the eye, sensitivity of the eye to light, swelling of the eye or eyelid, watery eyes or production of tears.||
|Macular edema: swelling and buildup of fluid in the center of the retina): blurry vision, blurry or wavy vision near or in the center of your field of vision, colors may appear washed out or faded.||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Before VYZULTA® is first opened, keep it in a fridge (between 2°C and 8°C). Once the bottle has been opened, VYZULTA® may be kept at room temperature up to 25°C. Discard the bottle and/or unused contents after 8 weeks. VYZULTA® should not be used after the expiry date on the bottle. Protect from light. Protect from freezing.
Keep out of reach and sight of children.