Imcivree · 4.1 Therapeutic indications · 1

HOS-099145 · has-adverse-reaction-information · PDF-Seite 11

Summary of the safety profile The most frequent adverse reactions are hyperpigmentation disorders (66%), injection site reactions (45%), nausea (36%), and headache (19%). Tabulated list of adverse reactions Adverse reactions obtained from clinical studies and post-marketing surveillance are listed below by MedDRA system organ class and frequency, following the frequency convention defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1 000 to < 1/100). Table 13 Adverse reactions 11 System organ class Frequency Very common Common Uncommon Neoplasms benign, Melanocytic naevus - Dysplastic naevus malignant and unspecified (incl cysts and polyps) Blood and lymphatic - Eosinophilia - system disorders Metabolism and - - Appetite disorder, nutritional disorders thirst Psychiatric disorders - Depression, Sleep disorder, insomnia, nightmares, disturbance in sexual libido decreased arousal, libido increased Nervous system Headache Dizziness Somnolence, disorders migraine, parosmia, dysguesia Eye disorders - - Scleral discolouration Ear and labyrinth - - Vertigo disorders Vascular disorders - - Hot flush Respiratory, thoracic and - - Yawning, mediastinal disorders rhinorrhoea, cough Gastrointestinal disorders Nausea, Diarrhoea, Abdominal distension, vomiting abdominal

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HOS-099141 · has-contraindication-information · PDF-Seite 9

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099140 · has-indication-information · PDF-Seite 2

IMCIVREE is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adults and children 2 years of age and above. IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.

HOS-099143 · has-interaction-information · PDF-Seite 10

No interaction studies have been performed. In vitro studies showed that setmelanotide has low potential for pharmacokinetic interactions related to cytochrome P450 (CYP) transporters and plasma protein binding.

HOS-099144 · has-pregnancy-information · PDF-Seite 10

Pregnancy There are no data from the use of setmelanotide in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. However, 10 administration of setmelanotide to pregnant rabbits resulted in decreased maternal food consumption leading to embryo-foetal effects (see section 5.3). As a precautionary measure, IMCIVREE should not be started during pregnancy or while attempting to get pregnant as weight loss during pregnancy may result in foetal harm. If a patient who is taking setmelanotide has reached a stable weight and becomes pregnant, consideration should be given to maintaining setmelanotide treatment as there was no proof of teratogenicity in the non-clinical data. If a patient who is taking setmelanotide and still losing weight gets pregnant, setmelanotide should either be discontinued, or the dose reduced while monitoring for the recommended weight gain during pregnancy. The treating physician should carefully monitor weight during pregnancy in a patient taking setmelanotide. Patients who are pregnant should be advised of the potential risk from the excipient benzyl alcohol (see section 4.4). Breast-feeding It is unknown whether setmelanotide is excreted in human milk. A non-clinical study showed that setmelanotide is excreted in the milk of nursing rats. No quantifiable setmelanotide concentrations were detected in plasma from nursing pups (see section 5.3). A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from IMCIVREE treatment taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Patients who are breastfeeding should be advised of the potential risk from the excipient benzyl alcohol (see section 4.4). Fertility No human data on the effect of setmelanotide on fertility are available. Animal studies did not indicate harmful effects with respect to fertility.

HOS-099142 · has-warning-information · PDF-Seite 9

Skin monitoring Setmelanotide may lead to generalised increased skin pigmentation and darkening of pre-existing nevi because of its pharmacologic effect (see sections 4.8 and 5.1). Full body skin examinations should be conducted annually to monitor pre-existing and new skin pigmentary lesions before and during treatment with setmelanotide. Heart rate and blood pressure monitoring Heart rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) for patients treated with setmelanotide. Prolonged penile erection Spontaneous penile erections have been reported in clinical studies with setmelanotide (see section 4.8). Patients who have a penile erection lasting longer than 4 hours should be instructed to seek emergency medical attention for potential treatment of priapism. Depression In clinical studies, depression has been reported in patients treated with setmelanotide (see section 4.8). Patients with depression should be monitored at each medical visit during treatment. Consideration should be given to discontinuing treatment if patients experience suicidal thoughts or behaviours. Patients with aHO and central diabetes insipidus Patients with aHO may have related disorders such as central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency, which impairs fluid regulation and increases the risk of hypernatraemia and volume depletion. In patients with aHO and concomitant DI/AVP, serum sodium levels, fluid balance, and hydration status should be closely monitored, particularly with the changes in body weight, or food and fluid intake, which may occur in response to setmelanotide therapy. Patients should be monitored more frequently during periods of decreased oral intake, intercurrent illness, or intensified caloric restriction. Doses of concomitant therapies should be adjusted as needed. 9 Patients with aHO and adrenal insufficiency Patients with aHO may have underlying hypothalamic-pituitary dysfunction, including secondary adrenal insufficiency due to impaired adrenocorticotropic hormone secretion. Adrenal function should be evaluated prior to initiating setmelanotide in patients with a history of hypothalamic or pituitary disease. Patients with known adrenal insufficiency should be adequately treated with glucocorticoid replacement therapy before starting setmelanotide. Patients should be monitored for clinical s

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