Consumer Information for: VYZULTA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

VYZULTATM is used to reduce the high pressure in the eye in patients with the following conditions:

  • open-angle glaucoma or ocular hypertension
What it does

VYZULTATM lowers the pressure in the eye by increasing the outflow of fluid from inside the eye.

When it should not be used

Do not use VYZULTA™ if you:

  • are allergic to latanoprostene bunod
  • are allergic to any of the other ingredients in VYZULTATM or to a component of the container.
What the medicinal ingredient is

Latanoprostene Bunod

What the non-medicinal ingredients are

Benzalkonium Chloride (as preservative), Citric Acid, EDTA, Glycerin, Polysorbate 80, Sodium Citrate and Water.

What dosage form it comes in

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.

Warnings and precautions

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.
  • tare pregnant or planning to become pregnant
  • are breast feeding 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 VYZULTATM .

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Proper use of this medication

How to take VYZULTA™:

  • Apply one drop of VYZULTATM 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 VYZULTATM. You may reinsert them 15 minutes after you have applied VYZULTATM .
  • If your doctor has prescribed other eye drops to be taken along with VYZULTATM , apply each medicine at least 5 minutes apart.
  • Use VYZULTATM exactly as your doctor has told you to. Do not apply VYZULTATM more than once a day.

Usual Dose

The recommended dose of VYZULTATM is one drop into the affected eye(s) once daily in the evening.

Overdose

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

Missed Dose

If you forget to use VYZULTATM, continue your treatment with the next dose the following day.

Side effects and what to do about them

These are not all the possible side affects you may feel when taking VYZULTA™. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:
Common:

  • eye irritation
  • eye redness
  • eye pain
  • pain in your eye at the application site
  • runny or stuffed nose, sore throat
Rare:
  • altered sense of taste
  • feeling of grittiness or having something in the eye
VYZULTATM may change colour of your eye or eyelid. The eye color change may not be noticeable for many months to years. The eye color and eyelid changes may be permanent. Tell your doctor if your eye color has changed. They may examine your eyes more often.

VYZULTATM may also cause your eye lashes to appear thicker and longer than they usually do and increase in number. Eyelash changes are reversible after treatment with VYZULTATM is stopped.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Common
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 build-up 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.

How to store

Before VYZULTATM is first opened, keep it in a fridge (between 2°C and 8°C). Once the bottle has been opened, VYZULTATM may be kept at room temperature up to 25°C. Discard the bottle and/or unused contents after 8 weeks. VYZULTATM 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.

Reporting 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 three 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
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.

More information

If you want more information about VYZULTA™:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php) or by calling 1-800-361-4261.

This leaflet was prepared by Bausch & Lomb Incorporated.
VYZULTA™ is a trademark of Bausch & Lomb Incorporated or its affiliates.

Last Revised: December 27, 2018

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