Consumer Information for: OXERVATE

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

OXERVATE is used to treat adults with moderate or severe ‘neurotrophic keratitis’. This disease affects the cornea (the transparent layer in the front part of the eye) and causes defects. These defects will not heal on their own. They may get worse and turn into corneal ulcers. OXERVATE helps the cornea heal.

What it does

OXERVATE contains a protein that helps your eye(s) heal and repair damage to the eye’s surface.

When it should not be used
  • you are allergic to this drug or any of the ingredients.
  • you are below 18 years of age
  • you are taking any eye drops containing corticosteroids (e.g. to treat ocular inflammation) or preservatives (e.g. benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide). Eye drops containing these substances could slow down or interfere with the healing of your eye and should therefore be avoided during treatment with this medicine.
  • you have an eye infection. The infection should be treated first. If you get an eye infection while using OXERVATE, you should stop your treatment and see your doctor right away.
What the medicinal ingredient is

Medicinal ingredients: cenegermin.

What the non-medicinal ingredients are

Non-medicinal ingredients: disodium hydrogen phosphate anhydrous, hydrochloric acid, mannitol, nitrogen, polyethylene glycol 6000, L-methionine, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, sodium hydroxide, trehalose dehydrate, and water for injections.

What dosage form it comes in

Ophthalmic solution (eye drops), 0.002% (20 mcg/mL)

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OXERVATE. Talk about any health conditions or problems you may have, including if you:

  • need surgery on your eye(s). You should not use this medicine if you need surgery or there are other problems with your eye(s).
  • experience a severe eye reaction. Treatment with OXERVATE may cause you mild to moderate discomfort such as eye pain.
  • have contact lenses. Contact lenses could interfere with the correct use of this medicine. Remove them before using this medicine. Wait 15 minutes after using this medicine and then reinsert them.

Other warnings you should know about:

Tell your doctor:

  • if you are pregnant or plan to become pregnant. It is not known if OXERVATE will harm your unborn baby.
  • if you are breast-feeding. It is not known if this medicine passes into breast milk.
Interactions with this medication

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

You should wait at least 15 minutes before or after using OXERVATE if you use any other eye drops. This will help to avoid one eye drop diluting the other eye drop. If you also use an eye ointment or gel or an eye drop with a thick consistency, you should use OXERVATE first, and then wait at least 15 minutes before using the other medicine.

Proper use of this medication

How to take OXERVATE:

You will receive an insulated container containing a weekly carton of OXERVATE. A separate delivery system carton will be provided. This will have medical devices for applying the medicine to your eye.

The weekly carton contains 7 vials of OXERVATE, 1 vial per day of the week. Each vial contains enough medication to administer six doses. The separate delivery system carton contains 7 vial adapters, 42 pipettes, 42 disinfectant wipes and a card to record the dose. The carton includes spare adapter (1), pipettes (3), and wipes (3).

Remove the weekly carton of OXERVATE from the insulated container. Store OXERVATE in a fridge as soon as you can and no later than 5 hours from when you receive the medicine from your pharmacist. This medicine is stored in a freezer at the pharmacy. You will have to wait up to 30 minutes for the first vial to thaw before you start using it.

Follow Steps 1 to 19 each day you use OXERVATE:

Take one vial of this medicine from the fridge in the morning. Take at the same time each morning and prepare it in the following way:

Step 1. Wash your hands.

Step 2. If you wear contact lenses, take them out before using the drops.

Step 3. Remove the plastic flip-off cap from the vial.

Step 4. Peel-off the back of the vial adapter blister pack.

Step 5. Without removing the vial adapter from its blister pack, connect it to the vial by firmly pushing it down until it snaps into place over the neck of the vial. The spike of the vial adapter should pierce through the vial’s rubber stopper. Once the vial adapter has been connected correctly, it should not be removed from the vial.

Step 6. Remove and discard the packaging of the vial adapter.

The multi-dose vial of OXERVATE is now ready for use (1 drop in the affected eye every 2 hours six times a day). The vial should be stored in the fridge between doses. If needed, the vial can be stored at room temperature below 25 oC. Do not remove the vial adapter between doses.

To withdraw and administer each dose of this medicine, follow the steps below:

Step 7. Take a single disinfectant wipe and gently clean the surface of the valve on the connector part of the vial adapter. After cleaning, wait for approximately 1 minute to allow the valve to dry.

Step 8. Take a pipette (dropper), by removing it from its protective packaging.

Step 9. Screw the pipette (clockwise) into the connector part of the vial adapter.

Step 10. Ensure that the pipette plunger is pushed all the way down.

Step 11. Turn the vial upside-down (with the pipette still connected) and gently pull the plunger until it stops, to draw the solution into the pipette. Ensure the plunger has reached the stop point.

Step 12. Check the pipette to ensure it contains the eye drops solution. Air bubbles may cause blockage and prevent the pipette from filling properly (especially at first withdrawal). If the pipette is empty, keep the vial with the connected pipette upside-down, push the plunger all the way in and pull it out again.

Step 13. Once it has been correctly filled, unscrew the pipette from the connector part of the vial adapter.

Step 14

  • Holding the pipette, pointing down, between your middle finger and thumb, tilt your head back and position the pipette above your affected eye.
  • Pull down your lower eyelid, folding between the inner eyelid and the eyeball.
  • Gently push the plunger in until a single drop is dropped into the folding tissue. Make sure you do not touch your eye with the tip of the pipette. With your head still tilted back, blink a few times so that the medicine covers the surface of your eye.

Step 15. Immediately discard the used pipette after use, even if there is still some liquid left in it. If a drop misses your eye, try again, using a new pipette and wipe.

Step 16. After each use throughout the day, place the vial back in the fridge (or keep it below 25 °C) for the rest of the day, with the vial adapter still connected.

Step 17. Repeat from Step 7 to Step 16 every 2 hours six times a day, using a new disinfectant wipe and a new pipette each time. Be sure to always wash your hands before you handle the vial or pipettes.

If you use drops in both eyes, repeat the above instructions for your other eye using a new pipette (in this case, you will need to use 2 vials per day).

Step 18. Discard the used vial at the end of each day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.

Step 19. Track each time you use an eye drop of this medicine on the weekly dose recording card provided with the delivery system. This will allow you to control that six doses have been taken at the end of each treatment day. On this card you should also write down the date of the first use of the weekly supply and the time of the vial opening (i.e. when you connect the vial adapter to the vial) over the week.

To ensure accurate dosing every 2 hours, you could set an alarm as a reminder for dosing.

Usual Dose:

The recommended dose is 1 drop in the affected eye 6 times a day at 2-hourly intervals, starting in the morning (i.e. 6 drops per day within 12 hours). You should continue your treatment for 8 weeks.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your vision may be temporarily blurred immediately after using this medicine. If this happens, wait until your vision clears before you drive or use machines. Do not take other eye medicines without talking to your doctor.

Overdose:

If you use more than you should, flush the affected eye with lukewarm water. Do not put in any more drops until it is time for your next regular dose. Continue with your next dose as scheduled.

If you think you have taken too much OXERVATE, 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 OXERVATE, continue with your next dose as scheduled. Do not use a double dose to make up for the forgotten dose. You can give the missed dose 2 hours after your last scheduled dose of the day, provided this is still within 12 hours from first opening the daily vial. Do not use more than 6 drops each day in the affected eye(s).

Speak to your doctor first if you intend to stop using OXERVATE.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side effects and what to do about them

What are possible side effects from using OXERVATE? These are not all the possible side effects you may feel when taking OXERVATE. If you experience any side effects not listed here, contact your healthcare professional.

The most common side effect of OXERVATE is eye pain. Other common side effects may include pain in the eyelid, feeling that there is something in the eye, increase of tears (this could include symptoms such as discharge in the eye), infection of the cornea with pus and swelling, and inflammation of the eye.

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.

Store the weekly carton containing 7 vials of OXERVATE in the fridge 2-8°C

After the vial adapter is connected to the vial, OXERVATE can be stored in the fridge or below 25°C. Discard the used vial at the end of the day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.

Do not use this medicine after the expiry date which is stated on the OXERVATE outer carton and vial label.

The pipettes included in the delivery system are single-use only. Each pipette should be discarded immediately after using, even if there is still some liquid left in it.

Keep out of reach and sight of children.

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; https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html 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.

If you want more information about OXERVATE:

  • 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 (https://www.canada.ca/en/health-canada.html) or by calling 1-800-.

This leaflet was prepared by Dompé farmaceutici S.p.A.

OXERVATE is imported/distributed by C.R.I., Dundas, Ontario L9H 7P3

Last Revised FEB-5-2019

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