Scenesse Implant for Vitiligo and EPP
SCENESSE is a medicine that contains the active substance afamelanotide. Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH). Afamelanotide works in a way like the natural hormone, by making skin cells produce eumelanin, which is a brown-black type of melanin pigment in the body.
Afamelanotide is used to increase the tolerance to sunlight in adults with several diseases that include erythropoietic protoporphyria (EPP), vitiligo, polymorphous light eruption and solar urticaria. All of these diseases feature an increased sensitivity to sunlight, which can cause toxic effects such as pain and burning. By increasing the amount of eumelanin, SCENESSE can help to delay the onset of pain due to skin photosensitivity (sensitive to sunlight).
How is SCENESSE used?
The implant is given as injection under your skin using a catheter tube and needle (subcutaneous use). Before inserting this medicine, the skin will be numbed where the implant is to be inserted. The implant is inserted directly under the skin folds on your waist or abdomen over your hip. At the end of the insertion procedure, you may be able to feel the implant under your skin. Over time the implant will be absorbed by the body, this will happen within 50 to 60 days after implantation.
One implant is injected every 2 months during the spring and summer months. Three implants per year are recommended, depending on the length of effect required. However, this number should not exceed more than 4 per year. The implant may be removed by a simple surgical procedure if needed.
Do not change the sun protection measures you normally follow to manage your disease and according to your skin phototype (UV sensitivity). Keep in mind that increased exposure to UV light will contribute to skin cancer development.
Your regimen should include sun-protective clothing, hats, shades and sunscreens with at least SPF 100. Zinc oxide is the gold standard for a sun block and should be used as well. Heliocare, an oral sun protectant, is a great adjunct to any sun protection regimen.
Because this medicine increases eumelanin, in most treated patients the skin will darken. This is an expected response to this medicine, and the darkening will slowly fade unless another implant is used.
Your doctor will need to regularly check your skin (full body) to monitor changes in moles (e.g. darkening) or other skin abnormalities. This is recommended to be performed every 6 months.
Please inform your doctor about new or changing skin abnormalities. Arrange for an early appointment if pigmented lesions like moles grow or if other growing, non-healing, weeping, plaque-like, wart-like, or ulcerated lesions appear.
Reasons why you may not want to use Scenesse can include:
- heart problems (including an irregular heart beat) or severe breathing problems (such as asthma or bronchitis)
- Cushing’s disease (a hormone disorder where the body produces too much of the hormone cortisol) 22
- Addison’s disease (a disorder of the adrenal glands causing a lack of some hormones)
- Peutz-Jeghers syndrome (a disorder that causes blockage of the bowel and where your hands, soles of your feet and surface of your lips may have brown freckles)
- epilepsy (or have been told that you are at risk of having fits)
- anemia (low counts of red blood cells in your blood).
- melanoma (an aggressive type of skin cancer), including in-situ melanoma, e.g. lentigo maligna; or if you have certain inherited conditions that increase the risk of developing a melanoma.
- skin cancer of the types, basal cell carcinoma or squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen’s disease), Merkel cell carcinoma or other malignant or premalignant skin problems.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Nausea (feeling sick), headache;
reactions at the implant site including pain, redness, itching, bruising and changes to color of overlying skin.
Common (may affect up to 1 in 10 people):
General changes to the skin including freckles and skin darkening;
- migraine (a severe headache); back pain;
- abdominal (tummy) pain, diarrhea and vomiting, decreased appetite;
- fatigue (tiredness), dizziness, drowsiness and weakness;
- hot flushes; upper respiratory tract infections (colds).
Uncommon (may affect up to 1 in 100 people): -
- Infected hair follicle, fungal infection, urinary tract infection
- Chills, fever, flu, flu-like illness, blocked nose, blocked sinuses, inflamed nose and throat, nose inflammation
- Depression, inability to sleep, poor quality sleep, fainting, fainting sensation, fall, hangover, weakness, inability to get legs comfortable, increased sensitivity to touch, headache following injury, burning sensation, abnormal taste sensation
- Swollen eye lids, red eyes, dry eye, difficulty focusing on close objects, ringing in ears - Palpitations, fast heart rate, bruising, high blood pressure, difficulty to make some sounds
- Inflamed lips, lip swelling, coloration on lip, gum pain, toothache, discolored gums, reduced sense of touch in mouth, lip discoloration, tongue discoloration
- Increased hunger, nausea following implant insertion, indigestion, infection in stomach and intestines, inflamed stomach and intestines, heartburn, inflamed stomach, irregular bowel movements, wind, bloated tummy, tummy pain
- Irregularity of skin, rash with small blisters, itch, rash, red rash, red swelling on skin, rash with small bumps, itchy rash, skin irritation, lighter skin patches, acne, eczema, secretions on skin, skin peeling, skin with loss of color, hair color changes, excessive sweating
- Joint pain, muscle pain, pain in arms and legs, sudden muscle contraction, pain in muscles and bones, stiffness of muscles and bones, joint stiffness, groin pain, feeling of heaviness, swelling in lower limbs - Heavy and prolonged period, abnormal period, breast tenderness, irregular periods, discharge from vagina, decreased sex drive
- Pain, swelling around site of implantation, bruising at injection site, irritation at injection site, enlargement at implant site, itching at implant site, implant falling out, change in color of skin at implant site
- Decrease white blood cells, abnormal liver function tests, decreased iron binding, increased cholesterol, increased sugar level, decreased blood iron level, increased blood pressure, blood in urine
- Wound complication, open wound
Scenesse is a medicine that can give sufferers of these diseases a new lease on life. Because it was just approved by the FDA, it will require a lot of flips and twists to get it to the patients who need it.