Afamelanotide

Afamelanotide is used in adults with erythropoietic protoporphyria 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 is administered through a small implant inserted under the skin. You will receive the implant in a medical setting 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.

You will be watched for a short time to make sure you do not have unwanted or dangerous side effects.

The skin where the implant was placed will be covered with a bandage. Leave the bandage in place 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.

Store in the refrigerator, protect from light, and do not freeze.

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

Tell your doctor if you use other medicines or have other medical conditions or allergies.

You should not receive afamelanotide if you are allergic to it.

Tell your doctor if you are pregnant or breastfeeding.

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 your skin to become darker, especially any moles or freckles you have. New moles or skin lesions may appear over time. Tell your doctor about any new moles or skin lesions.

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.

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.

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.

Afamelanotide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Other drugs may affect afamelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.