SCENESSE® (afamelanotide) for treatment of EPP

Under the approved labelling of SCENESSE®, the drug is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Important Safety Information

Who should not take SCENESSE^®?
You should not take SCENESSE^® if you are allergic to afamelanotide or any of the other ingredients of this medicine.

Please note that SCENESSE® is not suitable for patients involved in clinical trials for other EPP treatments.

Tell your healthcare provider as soon as possible if you become pregnant during treatment with SCENESSE®.

What are the possible side effects of SCENESSE^®?
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects occurred in more than 2% of patients who received SCENESSE^® during clinical trials:

Implant site reaction
Nausea
Oropharyngeal pain
Cough
Fatigue
Skin hyperpigmentation
Dizziness
Melanocytic nevus
Respiratory tract infection
Somnolence
Non-acute porphyria
Skin irritation

Before receiving SCENESSE®you should tell your doctor:

if you are taking, have recently taken or might take any other medicines.
if you are taking anticoagulant medicines used to prevent blood clots. These may include warfarin, acetylsalicylic acid or aspirin (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.
if you are participating in a clinical study.

Talk to your healthcare provider before receiving SCENESSE® if you are over 70 years of age.

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

Children and adolescents
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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this information sheet. By reporting side effects, you can help provide more information on the safety of this medicine.

To report SUSPECTED ADVERSE REACTIONS, contact CLINUVEL INC. at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

General information about the safe and effective use of SCENESSE^®:
Sun protection
Please maintain sun and light protection measures during treatment with SCENESSE^®to prevent phototoxic reactions related to EPP.

Skin monitoring
Darkening of pre-existing nevi and ephelides may occur with use of SCENESSE^®. A full body examination is recommended twice yearly to monitor pre-existing and new skin pigmentary lesions. Please inform your doctor about new or changing skin pigmentary lesions.

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SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD

Prescribing SCENESSE®

Administering SCENESSE®

Efficacy and Safety Data

Important Safety Information

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