Consumer medicine information

SCENESSE®

afamelanotide implant for subcutaneous use

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SCENESSE®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given SCENESSE® against the expected benefits it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What SCENESSE® is used for

SCENESSE® contains the active substance afamelanotide.

SCENESSE® is an implant used to treat patients with erythropoietic protoporphyria (EPP).

EPP is a rare disease in which patients have an increased sensitivity to the sun and light.

In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light. SCENESSE® is used to help prevent these symptoms so that these patients can lead more normal lives.

This medicine is a synthetic form of a body hormone called alphamelanocyte stimulating hormone (α-MSH). It works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the skin. By increasing the amount of eumelanin, SCENESSE® can help to reduce the sensitivity of the skin to the sun and light.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you are given SCENESSE®

When you must not be given SCENESSE®

if you are allergic to afamelanotide or any of the other ingredients of this medicine (listed under What SCENESSE® contains)
have liver problems

You should not use this medicine after the expiry date printed on the SCENESSE® pack or if the packaging is torn or shows signs of tampering.

SCENESSE® should not be given to children and adolescents up to 18 years of age because it has not been tested in this age group.

Before you start to use SCENESSE®

Talk to your doctor before you receive SCENESSE® if you have:

heart problems (including an irregular heart beat) or severe breathing problems (such as asthma or bronchitis)
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 such as basal cell carcinoma, squamous cell carcinoma (inclusive of carcinoma in situ, e.g. Bowen’s disease), Merkel cell carcinoma or other malignant or premalignant skin problems.
are pregnant or intend to become pregnant.
are breastfeeding.

If you have not told your doctor about any of the above, tell him/her before you are given SCENESSE®.

If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath, herbalist or internet.

Telephone the Poisons Information Centre on 13 11 26 if you have a concern.

While you are taking SCENESSE®

Things you must do

Make sure you follow your doctor’s instructions carefully and keep all appointments.

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 twice yearly.

Please inform your doctor about new or changing skin abnormalities. Arrange for an early appointment with your porphyria specialist if pigmented areas like moles grow or if other growing, non-healing, weeping, plaque-like, wart-like, or ulcerated lesions appear. A referral to a dermatology specialist might be necessary.

Make sure you use a method of contraception to prevent pregnancy during treatment with SCENESSE® and for 3 months after ending treatment. Tell your doctor immediately if you become pregnant while you are taking this medicine.

Your doctor can discuss with you the risks of taking it while you are pregnant.

How to be given 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 for inserting the implant.

One implant is injected every 2 months.

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 into the fatty area above your hip 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 dissolve and be absorbed by the body, this will happen within 50 to 60 days after implantation.

If you experience discomfort or are concerned, speak to your doctor. The implant may be removed by a simple surgical procedure if required. If necessary, this would be within 96 hours after insertion.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using SCENESSE®.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Do not be alarmed by the following list of side effects, you may not experience any of them.

Tell your doctor if you notice any of the following common side effects and they worry you:

Very common: may affect more than 1 in 10 people

nausea (feeling sick)
headache
reactions at the implant site including pain, redness, itching, bruising or changes to colour of overlying skin.

Common: may affect up to 1 in 10 people

general changes to the skin including darkening of the skin and freckles
migraine (a severe headache)
back pain
abdominal (tummy) pain
diarrhoea 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, 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, gum pain, toothache, discoloured gums, reduced sense of touch in mouth, lip discoloration, tongue discoloration
increased hunger, indigestion, infection in stomach and intestines, inflamed stomach and intestines, heartburn, 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 colour, hair colour 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,
decrease white blood cells, abnormal liver function tests, decreased iron binding, increased cholesterol, increased sugar level, decreased blood iron level, blood in urine
wound complication, open wound

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

How to store SCENESSE®

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

Refer to the product carton, which states: “Store at 2°C to 8°C” and protect from light.

Disposal

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. These measures will help protect the environment.

Product description

What SCENESSE® looks like and contents of the pack

SCENESSE® is a single, solid white to off-white sterile implant supplied in a Type 1 amber glass vial.

Each vial contains one SCENESSE® implant and is packaged individually in a cardboard box.

What SCENESSE® contains

The active ingredient is afamelanotide.

One implant contains 16 mg afamelanotide.

The inactive ingredients are:

polyglactin

Supplier

SCENESSE® is supplied in Australia by:

CLINUVEL PHARMACEUTICALS LTD
Level 11, 535 Bourke Street
Melbourne VIC 3000
Australia

This leaflet was prepared in October 2020.

The information provided applies only to: SCENESSE®.

AUST R 327947

Published by MIMS January 2021