What is this medication?

Afamelanotide (A fa me LAN oh tide) is used to decrease pain from sunlight in people with erythropoietic protoporphyria (EPP).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SCENESSE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• an unusual reaction to afamelanotide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This implant is inserted just under the skin in your stomach area by a healthcare professional. Keep the site where it was inserted clean and dry for 24 hours. After 2 months, your healthcare professional will remove the implant. A new implant may be inserted.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You should have your skin examined by a healthcare professional at least 2 times a year. You skin, freckles, or moles may get darker from this medicine.

Rarely, the implant can be expelled from the body. If you think the implant has been expelled, call your healthcare professional.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• pain at the insertion site

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• cough
• dizziness
• drowsiness
• nausea
• redness or irritation at the insertion site
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This does not apply. This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.