Cenegermin-bkbj Ophthalmic

WHY is this medicine prescribed?

Ophthalmic cenegermin-bkbj is used to treat neurotrophic keratitis (a degenerative eye disease that can lead to damage of the cornea [the outermost layer of the eye]). Cenegermin-bkbj is in a class of medications called recombinant human nerve growth factors. It works to heal the cornea.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Ophthalmic cenegermin-bkbj comes as a solution (liquid) to instill in the eye. It is usually instilled in the affected eye(s) six times a day, 2 hours apart, for 8 weeks. Instill cenegermin-bkbj at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use cenegermin-bkbj exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not shake the medication vial.

Use a new individual pipette for each application in each eye; do not reuse the pipettes.

Dispose of the vial at the end of each day, even if there is liquid remaining. Also dispose of the vial if it is more than 12 hours since you inserted the adapter into the vial.

Before you use cenegermin-bkbj for the first time, read the manufacturer's directions for use carefully. Ask your doctor or pharmacist if you have any questions.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using cenegermin-bkbj,

• tell your doctor and pharmacist if you are allergic to cenegermin-bkbj, any other medications, or any of the ingredients in cenegermin-bkbj ophthalmic. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Talk to your doctor first before using any other medications that are placed in the eye.

• if you are using another eye drop, use it at least 15 minutes before or after you instill cenegermin-bkbj eye drops. If you are using an eye ointment, gel, or other viscous (thick, sticky liquid) eye drop, use it at least 15 minutes after you instill cenegermin-bkbj eye drops.

• tell your doctor if you have an eye infection or if you develop one during your treatment with cenegermin-bkbj.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using cenegermin-bkbj, call your doctor.

• you should know that your vision may be blurry for a short amount of time after using cenegermin-bkbj. Do not drive a car or operate machinery until your vision returns to normal.

• you should know that cenegermin-bkbj eye drops should not be instilled while wearing contact lenses. If you wear contact lenses, remove them before instilling cenegermin-bkbj eye drops and you may put them back in 15 minutes later.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Cenegermin-bkbj may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• eye pain
• redness or swelling of the eye
• increased eye tearing
• feeling that something is in the eye

Cenegermin-bkbj may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Place this medication in the refrigerator within 5 hours of leaving the pharmacy when you pick it up, Do not freeze. Follow the directions in the manufacturer's information to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly. Dispose of any unused medication after 14 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone swallows cenegermin-bkbj, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.