IMCIVREE

IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic aetiology. Posology POMC, including PCSK1, deficiency and LEPR deficiency Adult population and children more than 12 years of age For adults and children 12 to 17 years of age, the starting dose is a 1 mg once daily subcutaneous injection for 2 weeks.

4), the dose can be increased to a 2 mg once daily subcutaneous injection (Table 1). If dose escalation is not tolerated, patients may maintain administration of the 1 mg once daily dose. 5 mg once daily subcutaneous injection. 5 mg once daily dose is well- tolerated, the dose can be increased to 3 mg once daily (Table 1).

5 mg with a maximum dose of 3 mg once daily (Table 1). 5 mg once daily subcutaneous injection for 2 weeks. If tolerated after 2 weeks, the dose can be increased to 1 mg once daily. 5 mg once daily dose. If the 1 mg dose is tolerated after 2 weeks, the dose can be increased to 2 mg once daily.

5 mg once daily (Table 2). 25 ml once daily Paediatric population (children aged 2 to <6 years) For patients aged 2 to <6 years, the dose titration in Table 3 should be followed. 5 mg once daily subcutaneous injection for 2 weeks. 025 ml) once daily.

25 mg once daily dose is tolerated, continue dose titration. 25 ml once daily The prescribing physician should periodically assess response to setmelanotide therapy. 4). Weight loss and control of hunger associated with setmelanotide can be maintained as long as the therapy is continued uninterrupted.

If treatment is discontinued, or if compliance to the dosing regimen is not maintained, symptoms of POMC and LEPR deficiency obesity will return. Bardet-Biedl Syndrome Adult population and children more than 16 years of age For adults and children 16 to 17 years of age, the dose titration in Table 4 should be followed.

1 ml) once daily. If the 1 mg once daily dose is tolerated, continue dose titration. Following the starting dose, if a subsequent dose is not tolerated, reduce to the previous dose level. If reduced dose is tolerated, continue dose titration.

Paediatric population (children aged 6 to <16 years) For patients aged 6 to <16 years, the dose titration in Table 5 should be followed. 05 ml) […]

Summary of the safety profile The most frequent adverse reactions are hyperpigmentation disorders (67%), injection site reactions (46%), nausea (36%), and headache (20%). Tabulated list of adverse reactions Adverse reactions observed in clinical trials are listed below by system organ class and frequency, following the MedDRA frequency convention defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1000 to <1/100).

Table 14 Adverse reactions FrequencyMedDRA System organ class Very common Common Uncommon Skin and subcutaneous tissue disorders Hyperpigmentation disordersa Pruritus, rash, dry skin, skin lesion, alopecia Erythema, skin striae, hyperhidrosis, lipodystrophy acquired, urticaria, skin exfoliation General disorders and administrative site conditions Injection site reactionsa, fatigue Asthenia, pain Temperature intolerance, chills, Gastrointestinal disorders Nausea, vomiting Diarrhoea, abdominal pain, dry mouth, dyspepsia, constipation, abdominal discomfort, gastrooesophageal reflux disease Gingival discolouration, abdominal distension, salivary hypersecretion, flatulence, Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, gamma- glutamyltransferase increased, hepatic enzyme increased, blood alkaline phosphatase increased Nervous system disorders Headache Dizziness Somnolence, migraine, parosmia, dysguesia Reproductive system and breast disorders Spontaneous penile erectionb, erection increasedb Vulvovaginal discomfortc Female sexual arousal disorderc, genital discomfort, genital disorder femalec, genital hyperaesthesia, dysmenorrhoeac Psychiatric disorders Depression, insomnia, disturbance in sexual arousal, libido increased Sleep disorder, nightmare, libido decreased Neoplasms Benign, Malignant and unspecified (incl cysts and polyps) Melanocytic naevus Dysplastic naevus Blood and lymphatic system disorders Eosinophilia FrequencyMedDRA System organ class Very common Common Uncommon Musculoskeletal and connective tissue disorders Back pain, myalgia, muscle spasms Arthralgia, musculoskeletal pain, pain in extremity, blood creatine phosphokinase increased Respiratory, thoracic and mediastinal disorders Cough Yawning, rhinorrhoea Eye disorders Scleral discolouration Vascular disorders Hot flush Ear and labyrinth disorders Vertigo Metabolism and nutritional disorders Appetite disorder, thirst a Grouped term (see “Description of selected adverse reactions” for full list of terms included).

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.

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. 8). Patients with depression should be monitored at each medical visit during treatment with IMCIVREE.

Consideration should be given to discontinuing IMCIVREE if patients experience suicidal thoughts or behaviours. Paediatric population The prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on growth and maturation should be evaluated.

The prescribing physician should monitor growth (height and weight) using age- and sex-appropriate growth curves. Excipients Benzyl alcohol This medicinal product contains 10 mg benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions.

There is an increased risk due to accumulation of benzyl alcohol in young children (less than 3 years old). Patients aged 2 years old should be monitored for any sign of metabolic acidosis (tachycardia, rapid breathing, confusion) while under treatment.

Patients who are pregnant or breastfeeding should be advised of the potential risk from the excipient benzyl alcohol, which might accumulate over time and cause metabolic acidosis. 2). ”

1.