Oxervate (Ophthalmic)

Cenegermin-bkbj eye drops is used to treat neurotrophic keratitis (a disease of the cornea of the eye).

This medicine is available only with your doctor's prescription.

It is very important that your eye doctor (ophthalmologist) check you or your child's progress at regular visits to ensure the medicine is working properly and to look for any unwanted effects.

This medicine may cause blurred vision or eye pain. Do not drive or do anything else that could be dangerous until you understand how this medicine affects you.

If your symptoms do not improve within a few days or if they get worse, contact your eye doctor (ophthalmologist) immediately.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a decision you will make together with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the usefulness of cenegermin-bkbj eye drops in children.

Geriatric

Studies done so far have not shown any specific problems that would limit the usefulness of cenegermin-bkbj eye drops in older adults.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased vision or any change in vision
• feeling of having something in the eye
• irritation, pain, redness, or swelling of the eye
• tearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Oxervate

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is available as a Delivery System Kit. Make sure to follow the instructions carefully to get the best out of your medicine.

To prepare the medicine:

• Push down the vial adapter blister pack onto the vial until it snaps into place over the vial's neck. Do not remove it from the vial after connecting it.
• Clean the surface of the valve on the connector part of the vial adapter with a sterile disinfectant wipe. Let it dry for about 1 minute.
• Screw a pipette (clockwise) into the connector part of the vial adapter. Make sure it is pushed all the way down.
• Turn the vial upside-down and gently pull the plunger until it stops to draw the eye drop solution into the pipette.
• Check the pipette to make sure it contains the eye drop solution. If it is empty, keep the vial with the connected pipette upside-down, push the plunger all the way in and pull it out again.
• Unscrew (counter-clockwise) and pull the pipette straight up after it has been correctly filled.

To use the eye drops:

• Wash your hands with soap and water before and after using this medicine.
• If you wear contact lenses, remove them before using this medicine. Wait at least 15 minutes before you put your contact lenses back in.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space.
• Gently push the plunger down until at least a drop is released into the eye pocket. 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.
• Throw the used pipette right away after use, even if there is still medicine left in it.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.

If you are also using other eye medicines, use them at least 15 minutes before or after using cenegermin-bkbj. Use cenegermin-bkbj 15 minutes before using any eye ointment, gel, or drop that is thick.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage forms (eye drops):For neurotrophic keratitis:Adults and children—Instill one drop into the affected eye 6 times a day at 2-hour intervals for 8 weeks.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unopened vial in its original carton in the refrigerator for up to 14 days. Keep the opened vial in the refrigerator or at room temperature for up to 12 hours. Do not shake the vial. Throw away any unused medicine after 12 hours.

• What eye condition is Oxervate used to treat?