SCENESSE 16 mg IMPLANT

Introduction

Package Leaflet: Information for the Patient

SCENESSE 16 mg implant

Afamelanotide

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may experience. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is SCENESSE and what is it used for

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 very similar way to the natural hormone, causing skin cells to produce eumelanin, a form of dark brown pigment of the body's melanin.

Afamelanotide is used to increase tolerance to sunlight in adult patients with a confirmed diagnosis of erythropoietic protoporphyria (EPP). EPP is a disease where the patient has increased sensitivity to sunlight, which causes harmful effects such as pain and burns. By increasing the amount of eumelanin, SCENESSE can help delay the onset of pain due to photosensitivity (sensitivity to sunlight) of the skin.

2. What you need to know before you use SCENESSE

Do not use SCENESSE

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

Warnings and precautions

Talk to your doctor before starting SCENESSE if you have or have had:

• heart problems (including irregular heartbeat) or severe respiratory problems (such as asthma or bronchitis);
• diabetes;

• Cushing's disease (a hormonal disorder in which the body produces too much cortisol hormone); Addison's disease (a disorder of the adrenal glands that causes a lack of certain hormones);
• Peutz-Jeghers syndrome (a disorder that causes intestinal blockage and in which the hands, soles of the feet, and surface of the lips can have brown spots)
• epilepsy (or if you have been told you are at risk of having seizures);
• anaemia (low red blood cell count);
• melanoma (a 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 cancer of the basal cell carcinoma or squamous cell carcinoma type (including in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or pre-malignant skin lesions.

Talk to your doctor before using SCENESSE if you are over 70 years old.

If you have ever had any of these diseases, your doctor will monitor your health more closely during treatment.

Sun protection

Do not change the sun protection measures you would normally follow for your EPP, according to your skin phototype (sensitivity to UV radiation). Note that increased exposure to UV radiation contributes to the development of skin cancer.

Skin monitoring

Since this medicine increases the production of eumelanin, in most patients treated, the skin will darken. This is an expected response to this medicine and the colour will fade unless another implant is used.

Your doctor should periodically examine your skin (all over your body) to check for possible changes in moles (e.g. darkening) or other skin abnormalities. It is recommended that skin examination be performed every 6 months.

Tell your doctor about any changes or new skin abnormalities. Make an appointment as soon as possible with your porphyria specialist if pigmented lesions such as moles grow, or if other lesions appear that increase in size, do not heal, suppurate, form plaques, have a wart-like appearance, or ulcerate. It may be necessary to consult a dermatologist.

Children and adolescents

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

Using SCENESSE with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking anticoagulant medicines (used to prevent blood clot formation). These medicines include warfarin, acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever or prevent blood clot formation) and non-steroidal anti-inflammatory medicines (NSAIDs), which are used to treat common ailments such as arthritis, headache, mild fever, rheumatism, and sore throat. This is because in patients taking such medicines, bruising or bleeding at the implant site may be increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should not receive SCENESSE, as it is not known whether it will affect the fetus or the breastfed child.

Women who could become pregnant must use a suitable contraceptive method, such as oral contraceptives, a diaphragm with spermicide, or an intrauterine device (also known as an IUD) during treatment and for 3 months after SCENESSE implantation.

Driving and using machines

With the use of this medicine, there is a risk of feeling drowsy and tired, especially in the 72 hours following administration. If you are affected, do not drive or use tools or machines. If you experience persistent drowsiness, talk to your doctor.

3. How to use SCENESSE

The implant should be inserted by a doctor trained to perform the procedure. Your doctor will decide with you the best time and place to insert the implant.

An implant will be injected every 2 months during the spring and summer months. Three implants per year are recommended, depending on the duration of the effect required. However, no more than 4 implants per year should be administered.

The implant is administered by subcutaneous injection, using a catheter and needle. Before inserting the medicine, your doctor may decide to administer a local anaesthetic to numb the area where the implant is to be inserted. The implant is inserted directly under the skin folds of the waist or abdomen, in an area known as the superior iliac crest.

After completing the insertion procedure, you may be able to feel the implant under the skin. Over time, the body absorbs the implant (which occurs between 50 and 60 days after implantation).

If you experience discomfort and are concerned, talk to your doctor. The implant can be removed by a simple surgical procedure if necessary.

If you have any further questions on 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 considered to be:

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

Nausea (feeling sick); headache; reactions at the implant site such as pain, redness, itching, bruising, and changes in skin colour.

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

General skin changes such as freckles and darkening; migraine (severe headache); back pain; abdominal pain (stomach), diarrhoea, and vomiting; decreased appetite; fatigue, dizziness, drowsiness, and weakness; hot flushes; upper respiratory tract infections (colds).

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

• Folliculitis, fungal infection, urinary tract infection.

• Chills, fever, flu, flu-like illness, nasal congestion, nasal passage obstruction, nasal and throat inflammation, sinusitis.

• Depression, insomnia, sleep disturbances, fainting, feeling of fainting, falls, hangover, weakness, discomfort in the legs, increased sensitivity to touch, headache after injury, burning sensation, altered sense of taste.

• Swollen eyelids, red eyes, dry eyes, difficulty focusing on close objects, ringing in the ears.

• Palpitations, increased heart rate, bruising, increased blood pressure, difficulty speaking.

• Swollen lips, lip swelling, lip discolouration, gum pain, toothache, gum colour change, decreased sense of touch in the mouth, lip colour change, tongue colour change.

• Increased appetite, nausea after implant insertion, indigestion, stomach and intestinal infection, stomach and intestinal inflammation, heartburn, stomach inflammation, irregular bowel movements, gas, abdominal bloating, abdominal pain.

• Skin irregularity, rash with small blisters, itching, rash, redness with swelling of the skin, rash with small bumps, itchy rash, skin irritation, lighter skin patches, acne, eczema, skin secretions, skin peeling, skin colour loss, hair colour changes, excessive sweating.

• Joint pain, muscle pain, pain in arms and legs, sudden muscle contraction, pain in muscles and bones, weakness in muscles and bones, joint weakness, feeling of heaviness, leg swelling.

• Heavier and longer menstrual periods, abnormal menstrual periods, breast tenderness, irregular menstrual periods, vaginal discharge, decreased sexual desire.

• Pain, swelling around the implant site, bruising at the injection site, irritation at the injection site, increased size at the implant site, implant expulsion, skin colour change at the implant site.

• Decreased white blood cell count, abnormal liver function tests, decreased iron binding, increased cholesterol, increased blood sugar level, decreased iron level, increased blood pressure, blood in the urine.

• Wound complications, open wounds.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SCENESSE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton. Your doctor will check the expiry date before inserting the implant.

Store in a refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.

The other ingredient is poly(D,L-lactide-co-glycolide).

Appearance and packaging

The implant is a white or off-white solid rod, approximately 1.7 cm long and 1.5 mm in diameter, placed in a type I amber glass vial with a PTFE-coated rubber stopper.

One vial containing one implant.

Marketing authorisation holder

CLINUVEL EUROPE LIMITED

10 Earlsfort Terrace

Dublin 2

D04 T380

Ireland

Phone: +353 768 888 035

mail@clinuvel.com

Manufacturer

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 1-2

73614 Schorndorf

Germany

Catalent UK Packaging Ltd

Lancaster Way

Wingates Industrial Estate

Westhoughton, Bolton

Lancashire BL5 3XX

United Kingdom

Date of last revision of this leaflet:

This medicine has been authorised under ‘exceptional circumstances’. This means that due to the rarity of your disease, it has not been possible to obtain complete information on this medicine.

The European Medicines Agency will review any new information on this medicine that becomes available every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

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This information is intended only for healthcare professionals:

Method of administration

SCENESSE is administered subcutaneously under aseptic conditions, as described below.

Administration of the medicine will only be performed by doctors trained and accredited by the marketing authorisation holder to administer the implant.

Instructions for use

• Remove the implant package from the refrigerator and let the medicine come to room temperature.
• The patient should be seated in a comfortable position or lying down with the upper body slightly elevated.
• Disinfect the skin of the superior iliac crest region.
• Anaesthetise the insertion site, if necessary, and after consulting the patient.
• Select a 14-gauge (1.6 mm internal diameter) catheter with needle.
• Mark 1.5 to 2 cm on the catheter shaft with surgical ink.
• Using a sterile technique, hold the catheter at the base; with two fingers, pinch a skin fold in a cranial direction in the superior iliac crest region of the patient.
• With the bevel of the needle facing upwards, insert 1.5 to 2 cm of the catheter laterally into the subcutaneous layer, at an angle of 30 to 45 degrees relative to the skin surface, with a continuous motion.

• With the catheter in place, remove the implant from the vial under aseptic conditions.
• Remove the needle from the catheter using a sterile technique.
• Transfer the implant to the catheter opening.
• Gently push the implant along the catheter lumen using a suitable instrument (such as a stylet).
• Apply gentle pressure with your finger to the insertion site while withdrawing the stylet and catheter.
• Confirm the subcutaneous insertion of the implant by palpating the skin in a cranial direction from the superior iliac crest region until it is located. Always verify the presence of the implant; if you have any doubts, check that the implant has not remained inside the catheter. If the implant cannot be inserted using the procedure described above, discard it and insert a new one. Do not insert a new implant unless it has been unequivocally confirmed that the first one has not been inserted.
• Apply compression with a small dressing to the injection site.
• Monitor the patient for 30 minutes to see if an allergic or hypersensitivity reaction (of an immediate type) occurs.

The implant can be surgically removed if necessary.