Scenesse · 4.3 Contraindications · 1

HOS-155549 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety profile is based on pooled data from clinical studies in 425 patients. The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema). In most cases these adverse reactions are reported to be mild in severity. Uncommon occurrences of hypersensitivity reactions, including anaphylaxis, have been reported in association with SCENESSE treatment (see section 4.4). Tabulated list of adverse reactions The adverse reactions reported during clinical studies conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention. 5 Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to <1/1,000). System Organ Class Very common Common Uncommon Rare Infections and Influenza Cystitis Candida infection infestations Upper respiratory Folliculitis tract infection Gastrointestinal infection Gastroenteritis Neoplasms benign, Melanocyte naevus Haemangioma malignant and unspecified (incl cysts and polyps) Blood and lymphatic Leukopenia system disorders Immune system Hypersensitivity, disorders Anaphylaxis Metabolism and Decreased appetite Hypercholesterola nutrition disorders Increased appetite emia Psychiatric disorders Depressed mood Confusional state including depression Insomnia Nervous system Headache Dizziness Balance disorder Dysgeusia disorders

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HOS-155545 · has-contraindication-information · PDF-Seite 3

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Presence of severe hepatic disease - Hepatic impairment (see section 5.2) - Renal impairment (see section 5.2)

HOS-155544 · has-indication-information · PDF-Seite 2

SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

HOS-155547 · has-interaction-information · PDF-Seite 4

No specific interaction studies have been performed with this medicinal product. Pharmacokinetic data for afamelanotide or any of its metabolites are very limited. As an oligopeptide with a short half-life, afamelanotide is expected to be rapidly hydrolysed into shorter peptide fragments and into its individual amino acids. However, due to the lack of data caution is warranted. 4 Patients taking substances which reduce coagulation, such as vitamin K antagonists (e.g. warfarin), acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.

HOS-155548 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential/contraception in females Women of childbearing potential have to use effective contraception during treatment with SCENESSE and for a period of three months thereafter. Pregnancy There are no or limited amounts of data from the use of afamelanotide in pregnant women. Animal studies are insufficient with respect to developmental toxicity (see section 5.3). A risk to newborns/infants cannot be excluded. SCENESSE should not be used during pregnancy and in women of childbearing potential not using effective contraception. Breast-feeding It is unknown whether afamelanotide or any of its metabolites are excreted in breast milk. No clinical data are available on the use of afamelanotide in breastfeeding women. A risk to newborns/infants cannot be excluded. SCENESSE should not be used during breastfeeding. Fertility There are no clinical data on the effects of afamelanotide on fertility. Animal studies have not shown any harmful effect on fertility and reproduction.

HOS-155546 · has-warning-information · PDF-Seite 3

Hypersensitivity Uncommon occurrences of hypersensitivity reactions, including anaphylaxis, have been reported following administration of SCENESSE. Appropriate medical support measures should be readily available when SCENESSE is administered. If a serious hypersensitivity reaction occurs, appropriate medical treatment should be initiated, the implant should be removed if needed and further treatment with SCENESSE should be discontinued (see section 4.8). Concomitant disorders not studied 3 Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushing’s disease, Addison’s disease, Peutz-Jeghers syndrome), neurological (including seizures) and haematological (especially anaemia) systems have not been evaluated. A careful decision must be made whether to treat patients with any of these conditions with this medicinal product. If such patients are treated they must be monitored after each implant administration, including vital signs, routine haematology, and biochemistry. Sun protection It is recommended that sun protection measures routinely adopted by each patient to manage their photosensitivity related to EPP and in accordance with their skin type (Fitzpatrick scale) are maintained during treatment with this medicinal product. Skin monitoring Afamelanotide may induce darkening of pre-existing pigmentary lesions due to its pharmacological effect. A regular full body skin examination (every 6 months) is recommended to monitor all pigmentary lesions and other skin abnormalities. If the skin changes noted are consistent with skin cancer or its precursors, or are ambiguous to the porphyria specialist, dermatology specialist consultation should be sought. The two total full body skin examinations per year are intended to: - detect early any skin cancers and their precursors induced by UV-exposure, as EPP patients can be expected to significantly increase their exposure to sunlight and UV light while on treatment with afamelanotide. EPP patients with fair skin may be more likely to request treatment and are more prone to developing UV light-associated skin changes, including cancer; - detect and monitor changes in pigmentary lesions, thus allowing early detection of melanoma. Special caution is warranted in patients with an - individual or family history of melanoma (inclusive of in-situ melanoma, e.g.

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