Afamelanotide is used in adults with erythropoietic protoporphyria (EPP). EPP is a condition that can cause severe pain or other skin reactions to sunlight or artificial light.

Afamelanotide is used to help increase the amount of pain-free time you can spend in sunlight or artificial light.

Afamelanotide may also be used for purposes not listed in this medication guide.

Afamelanotide may cause skin darkening, especially in moles or freckles. Tell your doctor about any new moles or skin lesions.

Afamelanotide is given in a tiny implant inserted under the skin above the front of your hip. You will receive the implant in a clinic or doctor's office once every 2 months.

The implant is inserted using a special tool that pushes the implant into place under your skin. After injecting the implant, your doctor will feel the area to make sure your implant has been correctly placed.

Your skin where the implant was placed will be covered with a bandage. Leave the bandage on for 24 hours.

You may be able to feel the implant through your skin, but it should not cause pain or discomfort. The implant will dissolve in your body over time.

Call your doctor if you think it has come out of place.

Afamelanotide may cause your skin to become darker, especially any moles or freckles you have. New moles or skin lesions may appear over time. Ask your doctor about skin symptoms to watch for.

Your will need a full-body skin examination every 6 months.

Usual Adult Dose for Porphyria:

16 mg implanted subcutaneously above the anterior supra-iliac crest every 2 months

Comments:
-This drug should be implanted by a health care professional proficient in the subcutaneous implantation procedure.
-Patients should maintain sun and light protection measures during treatment to prevent phototoxic reactions.

Use: To increase pain free light exposure in patients with a history of phototoxic reactions from erythropoietic protoporphyria.

Tell your doctor if you are pregnant or breastfeeding.

Afamelanotide is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a 2-month appointment to receive your next implant.

Since the afamelanotide implant contains a specific amount of the medicine, you are not likely to receive an overdose.

Avoid sunlight or tanning beds. Always wear protective clothing when you are outdoors and use any sunscreen your doctor recommends.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Afamelanotide may cause serious side effects. Call your doctor at once if you have:

• severe pain, swelling, or bleeding where the implant was placed;

• new or worsening skin lesions;

• a mole that has changed in size or color; or

• if the implant sticks out of your skin or comes out by itself.

Common side effects of afamelanotide may include:

• pain, itching, redness, swelling, bruising, or other irritation where the implant was placed;

• skin changes such as discoloration, scarring, or a hard lump where the implant was placed;

• skin irritation anywhere on your body;

• new moles or hair growth on the skin;

• cough, pain in your mouth or throat;

• dizziness, drowsiness, tiredness;

• nausea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.