Scenesse

Scenesse is a prescription medication used to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). 

Scenesse belongs to a group of drugs called melanocortin receptor agonists. It works by increasing production of melanin, tanning the skin and protecting it from light.

Scenesse comes as an implant about the size of a grain of rice. It is inserted under the skin by a healthcare professional once every two months during the spring and summer.

Common side effects include pain, redness and itching at the implant site, nausea, and headache. Scenesse may cause drowsiness. Do not drive or operate heavy machinery until you know how it affects you.

Scenesse is a prescription medication used to increase the tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Scenesse See the "Scenesse Precautions" section.

Common side effects of Scenesse include:

Very common (may affect more than 1 in 10 people):

• nausea
• headache
• reactions at the implant site including pain, redness, itching, bruising and changes to colour of overlying skin

Common (may affect up to 1 in 10 people):

• general changes to the skin including freckles and skin darkening
• migraine headache
• back pain
• abdominal pain
• diarrhea and vomiting
• decreased appetite
• fatigue (tiredness)
• dizziness
• drowsiness
• weakness
• hot flushes
• upper respiratory tract infections (colds)

This is not a complete list of Scenesse side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

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

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your healthcare provider if you are taking anticoagulant medicines used to prevent blood clots. These may include warfarin, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever or to prevent blood clotting) and a group of medicines called non-steroidal anti- inflammatory drug (NSAIDs), used to treat common ailments, such as arthritis, headaches, mild fever, rheumatism and sore throats. This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant.

Scenesse may lead to generalized increased skin pigmentation and darkening of pre-existing moles and freckles because of its pharmacologic effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing and new skin pigmentary lesions.

Do not change the sun protection measures you normally follow to manage your EPP and according to your skin phototype (UV sensitivity). Keep in mind that increased exposure to UV light will contribute to skin cancer development.

Do not use Scenesse:

• if you are allergic to afamelanotide or any of the other ingredients of this medicine
• if you have any severe condition of the liver
• if you have liver problems
• if you have kidney problems

There is a risk of feeling drowsy and tired when using this medicine, especially within 72 hours of administration. If you are affected, do not drive or use any tools or machines. If you suffer from continued drowsiness, then you should speak to your doctor.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Scenesse, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are taking anticoagulant medicines used to prevent blood clots. These may include warfarin, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever or to prevent blood clotting) and a group of medicines called non-steroidal anti- inflammatory drug (NSAIDs), used to treat common ailments, such as arthritis, headaches, mild fever, rheumatism and sore throats. This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant.

Talk to your doctor before receiving Scenesse if you have or have ever had:

• heart problems or severe breathing problems
• gastrointestinal problems
• diabetes
• Cushing’s disease (a hormone disorder where the body produces too much of the hormone cortisol)
• 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

Talk to your doctor before receiving Scenesse if you are over 70 years of age.

If you have ever had any of these conditions your doctor may have to monitor you more closely during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Scenesse. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication. However, it is not known how Scenesse will affect your unborn baby. The manufacturer recommends that women who could become pregnant should use adequate contraception such as oral contraceptives, diaphragm plus spermicide, intrauterine device (also known as a coil) during treatment and for three months after the last Scenesse implantation.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Scenesse crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Scenesse.

The implant will be inserted by a doctor who has been trained in the administration procedure. The doctor will decide with you the most suitable time and the site for inserting the implant.

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 is given as injection under your skin using a catheter tube and needle (subcutaneous use). Before inserting this medicine, your doctor may decide to give you a local anaesthetic to numb the area where the implant is to be inserted. The implant is inserted directly under the skin folds on your waist or abdomen in an area known as the supra-iliac crest.

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.

If you experience discomfort and are concerned, speak to your doctor. The implant may be removed by a simple surgical procedure if needed.

The recommended dosage of Scenesse is a single implant, containing 16 mg of afamelanotide, inserted subcutaneously above the anterior supra-iliac crest every 2 months.

Store Scenesse in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep this and all medicines out of the reach of children.