Cenegermin-bkbj (sen-e-GER-min - bkbj)

Treats neurotrophic keratitis (eye disease).

Brand Name(s):

Oxervate

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Drop

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is available as a Delivery System Kit. Make sure to follow the instructions carefully.
• 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.
• 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.
• Lie down or tilt your head back. With your index finger, pull down the lower lid of your eye to form a pocket.
• 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.
• Use a new sterile disinfectant wipe and a new pipette each time.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• 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.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have other eye or vision problems.
• This medicine may cause blurred vision or eye pain. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You may need to change your medicine or stop using it.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Blurred or decreased vision or any change in vision
• Eye discomfort, eye pain
• Feeling of having something in the eye
• Irritation, swelling, or tearing of the eye

If you notice other side effects that you think are caused by this medicine, tell your doctor

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