Oxervate

Oxervate is a prescription medication used to treat neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

Oxervate is a recombinant human nerve growth factor (rhNGF) and is the first drug approved in this category. Nerve growth factor (NGF) is a protein that helps maintain neurons and works in the eye to stimulate corneal epithelial cell growth and survival. NGF also promotes tear production and has been shown to support corneal nerve cell growth and survival, which is lost in neurotropic keratitis.

This medication comes as an eye drop and is typically used 6 times a day for eight weeks.

Common side effects include eye pain, ocular hyperemia (enlarged blood vessels in the white of the eyes), eye inflammation and increased lacrimation (watery eyes).

Oxervate is a prescription medication used to treat a rare disease of the cornea called neurotrophic keratitis. This condition is caused by damage to a nerve that helps your cornea sense things. Your cornea loses sensation, and corneal wounds that are hard to heal may form.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Common side effects of Oxervate include:

• Eye pain following installation
• Swelling of the eye
• Increase in tears
• Corneal deposits
• Foreign body sensation
• Ocular hyperemia (enlarged blood vessels in the white of the eyes)

This is not a complete list of Oxervate side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report these side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Contact lenses should be removed before applying Oxervate. Lenses may be reinserted 15 minutes after administration.

Oxervate may cause mild to moderate eye discomfort such as eye pain during treatment. Talk to your doctor if a more serious eye reaction occurs.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Oxervate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Oxervate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Oxervate or to any of its ingredients
• Have an infection in your eye. If you have an infection while using Oxervate, talk to 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 non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. There are no well-done studies that have been done in humans with Oxervate. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Oxervate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Oxervate.

Administer Oxervate eye drops exactly as prescribed.

If more than one topical eye drop product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer Oxervate 15 minutes prior to using any eye ointment, gel or other viscous eye drops.

If you wear contact lenses, remove them before administering Oxervate. You can put your contacts back in after 15 minutes.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Oxervate at the same time.

Preparation and Administration: Remove the weekly carton of Oxervate from the insulated container and store it for up to 14 days in a refrigerator (no later than 5 hours from when you receive the medicine from your pharmacist). Oxervate is stored in a freezer at the pharmacy. If treatment is started immediately after receiving the weekly carton, wait until the first vial is thawed (this could take up to 30 minutes when kept at room temperature up to 77°F (25°C)). Do not shake the vial.

Take an individual vial of Oxervate from the refrigerator in the 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 Oxervate.

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. 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 vial adapter.

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

Step 8. Remove a pipette from its protective packaging.

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 point.

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.

Step 14. 

• Sit or lie down to steady yourself when you instill Oxervate.
• Holding the pipette, pointing down, between your middle finger and thumb, tilt your head back and position the pipette above your affected eye. 
• With your other hand, pull down your lower eyelid, increasing the space between the inner eyelid and the eyeball (the conjunctival fornix). 
• 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 pipette.
• 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. If you miss your eye and there is no longer eye drop solution in the pipette, try again, using a new pipette and wipe (See Steps 7 to 14).

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 each time. 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 below 77°F (25°C) throughout the day. You can also store the vial in the refrigerator but do not freeze the vial.

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.

Step 19. Track each time you instill an eye drop of Oxervate on the weekly dose recording card provided with the delivery system. 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Oxervate is one drop into the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.

If you take too much Oxervate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store the weekly carton of Oxervate in the refrigerator as soon as you can for up to 14 days. Store it in the refrigerator no later than 5 hours from when you picked it up from the pharmacy.
• Oxervate is stored in the freezer at the pharmacy. If you begin treatment right away after picking up the medication, you will have to wait until the first vial is thawed.
• 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.
• Do not shake the vial.
• Keep this and all medicines out of the reach of children.

This page was written by Megan Tran, PharmD Candidate 2020 | UT Austin College of Pharmacy