Description
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.
Afamelanotide 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 or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Implant
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of afamelanotide implant in the elderly.
Breastfeeding
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.
Drug Interactions
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
A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin above your hip bone every 2 months.
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
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.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
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
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
Incidence not known
- Chest tightness
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- trouble breathing
- unusual tiredness or weakness
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
Less common
- Darkening of the skin or lips
- 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.
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