Pronunciation:

a-fam-e-LAN-oh-tide

Dosage Forms:

• Implant

Classifications:

Therapeutic—

Protectant, Dermatological

Uses of This Medicine:

Afamelanotide implant is used to increase pain free light exposure in patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). EPP is a rare inherited disease caused by a genetic mutation that makes your skin extremely sensitive to light. Symptoms include redness, pain, swelling, and tingling sensation of the skin.

Afamelatonide works by stimulating the production of eumelanin pigment in the skin to block the penetration of light through the skin and help prevent painful skin reactions.

This medicine is to be given only by a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of afamelanotide implant in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of afamelanotide implant in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A doctor will give you this medicine. The afamelanotide implant will be placed under your skin above your hip bone once every 2 months, before and during periods of high sunlight exposure, (eg, from spring to autumn).

You will be monitored 30 minutes after receiving the implant for any allergic reactions caused by the medicine.

Call your doctor right away if you feel the implant is not in the proper place.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the implant is in the proper place and is working properly.

You may have some darkening of the skin and skin lesions while receiving this medicine. A regular full body skin examination (twice yearly) is needed to check for pre-existing and new skin lesions.

Wear protective clothing and hats and stay out of any bright light, or direct sunlight especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds. These would help prevent blisters, itching, rash, redness, swelling, or burning sensation of the skin.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bruising, discoloration of the skin, itching, redness, swelling, or pain at the implant site

Less common

Cough

fever

sneezing

sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nausea

unusual tiredness or weakness

Less common

Darkening of the skin or lips

dizziness

sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.