Cenegermin-Bkbj - Ophthalmic

Pronunciation: sen-EH-jer-men

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to treat a certain eye disorder (neurotrophic keratitis) that causes a loss of nerve function to a certain part of your eye (the cornea). Cenegermin-bkbj is a man-made form of a substance made by your body. It is used by your body to help maintain and make more nerve cells in your eyes. This medication may help prevent decreased vision or loss of vision caused by neurotrophic keratitis.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication 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, which could take up to 30 minutes at room temperature. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water.

Use this medication in the affected eye(s) as directed by your doctor, usually 6 times a day, about 2 hours apart starting in the morning.

To apply eye drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Take a vial out of the refrigerator and follow the manufacturer's directions to prepare and use this medication. If you are directed to use this medication in both eyes, you will need to use 2 vials each day. After you open a vial for use, connect the vial adapter as directed. The opened vial can be put back in the refrigerator for up to 12 hours. If needed, the opened vial may also be stored at room temperature for up to 12 hours. Do not freeze or shake the vial. Carefully follow the directions to use the single-use pipette dropper with the vial.

If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. With your head tilted back, blink a few times so that the medicine covers the surface of your eye. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to rub your eye. If directed to use this medication in both eyes, repeat these steps for your other eye. Only use 1 pipette dropper for each eye and each dose. Throw away the used pipette dropper right away after use. If you miss your eye and there is no longer any eye drop solution in the dropper, try again, using a new pipette dropper.

Throw away the used vial at the end of each day (after 12 hours) even if there is still some eye drop solution left in it.

If you are using another kind of eye medication (such as drops or ointments), wait at least 15 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Wait several minutes for your vision to clear before driving or operating machinery.

Use this medication regularly to get the most benefit from it. To help you remember, you may want to set an alarm as a reminder for dosing. Mark the provided weekly dose recording card to track each time you use a dose. Continue to use this medication for the full time prescribed (usually 8 weeks).

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Eye discomfort, pain, redness, watery eyes, or temporary blurred vision may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using cenegermin-bkbj, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • eye infection

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you can do it safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as eye exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Within 5 hours after leaving the pharmacy, store the weekly carton in the refrigerator away from moisture. Do not freeze or shake. Use/discard within 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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