(cenegermin-bkbj) ophthalmic solution, for topical ophthalmic use
Read this Instructions for Use before you start using
OXERVATE™ and each time you get a refill. There may be new information. This
leaflet does not take the place of talking to your doctor about your medical
condition, or your treatment. Only you and your doctor can decide if OXERVATE
is right for you. Share the important information in this leaflet with members
of your household.
- OXERVATE is for use in the eye.
- Do not shake the OXERVATE vial.
- Use OXERVATE with the vial adapters, sterile disinfectant
wipes, and pipettes that come with your Delivery System Kit.
OXERVATE is supplied in an insulated pack, in weekly
cartons containing 7 multiple-dose vials.
OXERVATE is supplied with an accompanying Delivery System
Kit. The Delivery System Kit will have medical devices for withdrawing and
You will receive both the OXERVATE weekly carton(s) and
the Delivery System Kit from the pharmacy.
The OXERVATE carton contains:
- 7 multiple-dose vials of OXERVATE (1 vial per day of the
The Delivery System Kit contains the following:
- 7 vial adapters
- 42 pipettes
- 42 sterile disinfectant wipes and
- Dose Recording Card (1)
- Extra adapter (1) pipettes (3) and wipes (3) are included
How should I store OXERVATE?
- Remove the weekly carton(s) of OXERVATE from the
insulated pack and store it for up to 14 days in a refrigerator in the original
carton as soon as you can.
- Store the weekly carton(s) at 36°F to 46°F (2°C to 8°C) no
later than 5 hours from when you receive the medicine from your pharmacy. Do
- OXERVATE is stored in a freezer at the pharmacy. If you
start treatment right away after receiving the weekly carton, you will have to
wait until the first vial is thawed. Thaw the vial at room temperature up to
77°F (25°C). Thawing the vial could take up to 30 minutes when kept at room
- Keep all medicines out of the reach of children.
Follow Steps 1 to 19 each day you use OXERVATE.
Gather your supplies:
- Remove 1 vial of OXERVATE from the refrigerator in the
morning (always at the same time each morning) to use during the day. If
OXERVATE is to be used in both eyes, remove 2 vials from the refrigerator
- 1 vial adapter
- 1 pipette (if both eyes 2 pipettes)
- 1 sterile disinfectant wipe (if both eyes 2 sterile
- Dose Recording Card
Step 1. Wash your hands.
Step 2. If you wear contact lenses, take them out
before using OXERVATE.
Step 3. Remove the plastic flip-off cap from the
Step 4. Peel-off the back of the vial adapter
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 vialÃ¢â¬™s rubber stopper. After the vial adapter has been
connected correctly, do not remove it from the vial.
Note: After the vial adapter is connected to the
vial, OXERVATE can be stored in the refrigerator between 36°F to 46°F (2°C to
8°C) for up to 12 hours.
If needed, the OXERVATE with the connected vial adapter
may be stored at room temperature up to 77°F (25°C).
Step 6. Remove and throw away the packaging of the
The multiple-dose vial of OXERVATE is now ready for use
(1 drop in the affected eye every 2 hours 6 times a day).
To withdraw and give each dose of OXERVATE, follow Steps
7 to 19:
Step 7. Take a single sterile disinfectant wipe
and gently clean the surface of the valve on the connector part of the vial
After cleaning, wait for about 1 minute to allow the
valve to dry.
Step 8. Remove a pipette from its protective
Step 9. Screw the pipette (clockwise) into the
connector part of the vial adapter.
Step 10. Make sure that the pipette plunger is
pushed all the way down.
Step 11. Turn the vial upside-down with the
pipette still connected. Gently pull the plunger until it stops, to draw the
eye drop solution into the pipette. Make sure the plunger has reached the stop
Step 12. Check the pipette to make sure it
contains the eye drop solution. Air bubbles may cause blockage and prevent the
pipette from filling properly (especially the first time you withdraw the eye
drop solution). 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. After the pipette has been correctly
filled, unscrew the pipette from the connector part of the vial adapter
(counter-clockwise). Pull the pipette straight up to remove it.
- Sit or lie down to steady yourself when you instill
- Holding the pipette, pointing down, between your middle
finger and thumb, tilt your head back and position the pipette above your
- With your other hand, pull down your lower eyelid,
increasing the space between the inner eyelid and the eyeball (the conjunctival
- Gently push the plunger down until at least a drop is
released into the conjunctival fornix.
- Make sure you do not touch your eye with the tip of the
- With your head still tilted back, blink a few times so
that the medicine covers the surface of your eye.
Step 15. Throw away the used pipette right away
after use, even if there is still some eye drop solution left in it.
Only use 1 pipette for each eye and each dose.
If you miss your eye and there is no longer any eye drop
solution in the pipette, try again, using a new pipette and wipe (See Steps 7
Step 16. After each use throughout the day, place
the vial back in the refrigerator or keep it below 77°F (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 6 times a day, using a new sterile disinfectant wipe and a new pipette
If you use drops in both eyes, repeat the above
instructions for your other eye using a new pipette. You will need to use 2
vials each day.
Store the vial at or below 77°F (25°C) throughout the
day. You can also store the vial in the refrigerator but do not freeze the
Step 18. Throw away the used vial at the end of
each day even if there is still some eye drop solution left in it. Throw away
the vial no later than 12 hours from the time you connected the vial adapter to
it even if there is eye solution still left in the vial.
Step 19. Track each time you instill an eye drop
of OXERVATE on the weekly Dose Recording Card provided with the delivery
This will allow you to track your 6 doses each treatment
day, the date of the first use of the weekly supply and the time of the vial
opening which is when you connect the vial adapter to the vial during the week.
To make sure accurate dosing every 2 hours, you may want
to set an alarm as a reminder for dosing.
(ox'-er-vayt) (cenegermin-bkbj) ophthalmic solution, for topical ophthalmic use
What is OXERVATE?
OXERVATE is a prescription eye drop solution used to
treat a condition called neurotrophic keratitis. OXERVATE is safe and effective
in children two years of age and older.
Before you use OXERVATE, tell your doctor about all of
your medical conditions, including if you:
- have an infection in your eye. If you get an eye
infection while using OXERVATE, talk your doctor right away.
- are using any other eye drops.
- wear contact lenses.
- are pregnant or plan to become pregnant. It is not known
if OXERVATE will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if OXERVATE passes into your breast milk. Talk to your doctor about the best
way to feed your baby if you use OXERVATE.
Tell your doctor about all the medicines you take,
including prescription and over-the counter medicines, vitamins, and herbal
How should I use OXERVATE?
- See the complete Instructions for Use at the end of this
Patient Information leaflet for detailed instructions about the right way to
- Use OXERVATE exactly as your doctor tells you.
- Use 1 drop of OXERVATE in the affected eye or both eyes
if needed, 6 times each day, about 2 hours apart starting in the morning.
Continue your treatment for 8 weeks.
- If you use any other eye drops, wait at least 15
minutes before or after using OXERVATE. 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
that is thick, use OXERVATE first, and then wait at least 15 minutes
before using the other eye ointment, gel, or drops.
- If you wear contact lenses in your affected eye or both
eyes remove them before using OXERVATE and wait 15 minutes after using
OXERVATE before reinserting them.
- If you miss a dose of OXERVATE, take your next dose at
your scheduled time. Do not take an extra dose to make up for a missed dose.
- Do not use other eye medicines without talking to
- Talk to your doctor first before you stop using OXERVATE.
- If you have any questions about how to use OXERVATE, ask
your doctor or pharmacist.
What should I avoid while using OXERVATE?
Your vision may be blurred for a short time after using
OXERVATE. If this happens, wait until your vision clears before you drive or
What are the possible side effects of OXERVATE?
The most common side effect of OXERVATE is eye pain,
enlarged blood vessels in the white of the eyes (ocular hyperemia), swelling
(inflammation) of the eye, and increase of tears (increased lacrimation).
Tell your doctor if you have any side effects that bother
you. These are not all the possible side effects of OXERVATE. Call your doctor
for medical advice about side effects. You may report side effects to FDA at
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use OXERVATE for a
condition for which it was not prescribed. Do not give OXERVATE to other
people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or doctor for information
about OXERVATE that is written for health professional.
What are the ingredients in OXERVATE?
Active ingredient: cenegermin-bkbj
Inactive ingredients: disodium hydrogen phosphate
anhydrous, hydroxypropylmethyl cellulose, L-methionine, mannitol, polyethylene
glycol 6000, sodium dihydrogen phosphate dihydrate, trehalose dihydrate, Water
for Injection, USP, and hydrochloric acid and/or sodium hydroxide to adjust pH.
This Patient Information has been approved by the U.S.
Food and Drug Administration.