Scenesse

Package leaflet: Information for the patient

SCENESSE 16 mg implant

afamelanotide
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you get any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What SCENESSE is and what it is used for
2. What you need to know before receiving SCENESSE
3. How SCENESSE is used
4. Possible side effects
5. How SCENESSE is stored
6. Contents of the pack and other information

1. What SCENESSE is and what it is used for

SCENESSE contains the active substance afamelanotide (as acetate). Afamelanotide is a synthetic form of a hormone naturally present in the body called alpha-melanocyte-stimulating hormone (α-MSH). Afamelanotide acts similarly to the natural hormone, stimulating skin cells to produce eumelanin, a type of brown-black melanin pigment present in the body.
Afamelanotide is used to increase tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP). EPP is a condition in which patients have increased sensitivity to sunlight, which can cause toxic effects such as pain and burning.
By increasing the amount of eumelanin, SCENESSE may help delay the onset of pain due to photosensitivity (sensitivity to sunlight) of the skin.

2. What you need to know before receiving SCENESSE

Do not use SCENSE

• if you are allergic to afamelanotide or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease
• if you have liver problems
• if you have kidney problems.

Warnings and precautions
Talk to your doctor before receiving SCENSE if you have or have previously had:

• heart problems or severe respiratory problems;
• gastrointestinal problems;
• diabetes;
• Cushing's disease (a hormonal disorder in which the body produces excessive amounts of the hormone cortisol);
• Addison's disease (an adrenal disorder causing a deficiency in certain hormones);
• Peutz-Jeghers syndrome (a disorder causing intestinal blockage and characterized by brown freckles on the hands, soles of the feet, and lips);
• epilepsy (or have been told you are at risk of seizures);
• anaemia (low number of red blood cells in the 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 melanoma;
• skin tumours such as basal cell carcinoma or squamous cell carcinoma (including in situ carcinoma, e.g. Bowen’s disease), Merkel cell carcinoma, or other malignant or pre-malignant skin conditions.

Talk to your doctor before receiving SCENESSE if you are over 70 years old.
If you have previously had any of these conditions, your doctor may need to monitor you more closely during treatment.

Sun protection
Do not change your usual sun protection measures used to manage erythropoietic protoporphyria and according to your skin phototype (i.e. your sensitivity to UV light). Be aware that increased exposure to UV light contributes to the development of skin tumours.

Skin monitoring
Since this medicine increases eumelanin, the skin darkens in most treated patients. This is an expected response to the medicine, and the darkening fades slowly, unless another implant is administered.

Your doctor should periodically examine your skin (full body) to detect changes in moles (e.g. darkening) or other skin abnormalities. Skin examinations are recommended every 6 months.

Inform your doctor if you notice new skin abnormalities or changes in existing ones. Promptly schedule an appointment with a porphyria specialist if pigmented lesions such as moles grow, or if new lesions appear that are expanding, do not heal, are oozing, plaque-like, wart-like, or ulcerated. A dermatologist may need to be consulted.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and SCENESSE
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and breastfeeding
Do not use SCENESSE if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, as the effects on the unborn child or breastfed infant are unknown.

Women of childbearing potential must use effective contraception, such as oral contraceptives, diaphragm plus spermicide, or an intrauterine device (also known as an IUD), during treatment and for three months after the last SCENESSE implant.

Driving and using machines
There is a risk of feeling drowsy or tired when using this medicine, especially within 72 hours after implantation. If you experience these symptoms, do not drive or operate tools or machinery. If you experience persistent drowsiness, consult your doctor.

3. How SCENESSE is used

The implant will be inserted by a doctor who has received adequate training in the insertion procedure.
Your doctor will decide together with you the most suitable timing and site for implant insertion.
One implant is inserted every 2 months prior to anticipated exposure, and during periods of increased
exposure, to sunlight. The number of implants per year and the total duration of treatment will be
determined by the specialist doctor.
The implant is inserted via injection under the skin, using a catheter and a needle (subcutaneous use).
Before inserting this medicine, your doctor may decide to apply a local anaesthetic to numb the area
where the implant will be placed. The implant is inserted directly under the skin folds on the waist or
abdomen, in an area known as the iliac crest.
After 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 occurs within 50–60 days after insertion.
If you experience discomfort or have any doubts, consult your doctor. If necessary, the implant can be
removed by a simple surgical procedure.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are reported:
Very common (may affect more than 1 in 10 people):

• nausea (feeling unwell);
• headache

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

• influenza, upper respiratory tract infection (cold);
• general skin disorders, including darkening of freckles and moles;
• skin rash with small blisters, itching, rash, red rash, itchy rash;
• dizziness, drowsiness and migraine (severe headache);
• hot flushes, flushing, sensation of warmth and reddening of the skin;
• abdominal pain (stomach), toothache, diarrhoea and vomiting;
• pain in arms and legs, muscle and bone pain or weakness, back pain;
• fatigue, pain, fever, implant site reactions including pain, bruising, swelling, bleeding, itching and skin discolouration at the site, influenza-like illness, cough, nasal congestion, inflamed nose and throat.

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection, folliculitis, stomach and intestinal infection;
• hypersensitivity and severe allergic reactions, including anaphylaxis (symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue);
• decreased or increased appetite;
• depressed mood including depression, inability to sleep, poor quality of sleep;
• fainting, feeling faint, weakness, inability to relax legs, balance disorders;
• dry eyes, eye pain, red eyes, difficulty focusing, light sensitivity, ear ringing;
• palpitations, bruising, bleeding, high blood pressure;
• blocked sinuses;
• stomach and intestinal inflammation, heartburn, irritable bowel syndrome, intestinal gas, lip swelling, reduced mouth touch sensation, gum pain;
• acne, eczema, red swollen skin lesion, dry skin, hair colour change, excessive sweating, nail pigmentation, lip discolouration, skin peeling, burning sensation of the skin, skin colour change including loss of colour, oily skin, urticaria;
• joint stiffness, muscle and bone stiffness, sudden muscle contractions, muscle pain;
• breast tenderness, irregular menstruation, painful menstruation;
• chills, feeling of warmth, hangover-like feeling, malaise, swelling of hands or legs;
• abnormalities in liver function tests, reduced iron binding, increased sugar levels, decreased iron levels in blood, blood in urine;
• falls and injuries;
• expulsion of the device.

Rare (may affect up to 1 in 1,000 people):

• fungal infection;
• decrease in white blood cells;
• increased cholesterol;
• confusion, headache following trauma, taste disturbances;
• eyelid swelling;
• increased heart rate;
• irregular bowel movements, inflammation of the lips, colour changes of gums, lips and tongue;
• red or brown nodules on the skin (called “lichen planus”), vitiligo;
• heavy and prolonged menstrual bleeding, vaginal discharge, decreased sexual desire;
• weight gain;
• wound complications, nausea after implant insertion.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How SCENESSE is stored

Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date stated on the vial and
on the outer packaging. The doctor will check the expiry date before using the implant.
Store in a refrigerator (2°C – 8°C).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SCENESSE contains
The active substance is afamelanotide. One implant contains 16 mg of afamelanotide (as acetate).
The other component is poly (DL-lactide-co-glycolide).

Description of the appearance of SCENESSE and contents of the pack
The implant is a solid rod, white to off-white in colour, approximately 1.7 cm in length and 1.5 mm in diameter, contained in an amber glass vial sealed with a rubber stopper coated in PTFE.
Pack size: one vial containing one implant.

Marketing Authorisation Holder
CLINUVEL EUROPE LIMITED
10 Earlsfort Terrace
Dublin 2
D02 T380
Ireland
Tel: +353 1513 4932
[email protected]

Manufacturer
CLINUVEL EUROPE LIMITED
Alexandra House
The Sweepstakes
Ballsbridge
Dublin 4
D04 C7H2
Ireland

This medicinal product has been granted a marketing authorisation under "exceptional circumstances". This means that, due to the rarity of the disease, complete information about this medicinal product could not be obtained for scientific and ethical reasons.
The European Medicines Agency will review any new information on this medicinal product annually, and this patient information leaflet will be updated if necessary.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

The following information is intended exclusively for healthcare professionals:

Method of administration
SCENESSE is inserted subcutaneously under aseptic conditions, as described below.
Implant insertion must be performed by a physician experienced and accredited by the marketing authorization holder for implant insertion.

Instructions for use

• Remove the packaged implant from the refrigerator and allow the medicinal product to warm to room temperature.
• Seat the patient in a comfortable position or have them lie down with the upper body slightly elevated.
• Disinfect the skin over the iliac crest.
• Anesthetize the insertion site, if considered necessary and after consulting with the patient.
• Select a 14-gauge (internal diameter 1.6 mm) catheter with needle.
• Mark the catheter shaft 1.5 to 2 cm from the tip using surgical ink.
• Holding the catheter at its base using a sterile technique, grasp and stabilize the skin at or above the patient’s iliac crest with two fingers.
• With the needle bevel facing upward, insert the catheter laterally 1.5–2 cm into the subcutaneous tissue at an angle of 30–45 degrees to the skin surface in one smooth, continuous motion.
• Once the catheter is in place, aseptically remove the implant from the vial.
• Remove the needle from within the catheter using a sterile technique.
• Transfer the implant to the tip of the catheter.
• Using a suitable device (such as a trocar), gently push the implant the full length of the catheter lumen.
• Apply finger pressure over the insertion site during removal of the trocar and catheter.
• Confirm implant insertion by palpating the skin and subcutaneous tissue at or above the iliac crest until the implant is located. Always verify the presence of the implant; if in doubt, check whether the implant remains within the catheter. If the implant has not been inserted during the above-described procedure, discard the implant and insert a new one. Do not insert a new implant unless failure of the first implant to insert has been unequivocally confirmed.
• Apply a small compressive dressing to the injection site.
• Observe the patient for 30 minutes to monitor for development of an immediate-type allergic or hypersensitivity reaction.

The implant may be surgically removed if necessary.