Imcivree

IMCIVREE should be prescribed and supervised by physicians experienced in the diagnosis and management of rare forms of obesity with genetic or hypothalamic origin. Posology Acquired hypothalamic obesity Adults and children 6 years of age and above The dose titration in Table 1 should be followed.

4) and clinical response. 25 mg if needed. 3 ml once daily Children from 4 to less than 6 years of age The dose titration in Table 2 should be followed depending upon patient weight. 4) and clinical response. 25 mg if needed. 3 ml once daily POMC, including PCSK1, deficiency and LEPR deficiency Adults and children 12 years of age and above For adults and children 12 years of age and above, the starting dose is 1 mg once daily for 2 weeks.

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

5 mg with a maximum dose of 3 mg once daily (Table 3). 5 mg once daily 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 may be increased to 2 mg once daily.

5 mg once daily (Table 4). 25 ml once daily Children from 2 to less than 6 years of age For paediatric patients from 2 to less than 6 years of age, the dose titration in Table 5 should be followed. 5 mg once daily for 2 weeks. 025 ml) once daily.

25 mg once daily dose is tolerated, dose titration should be continued. 05 ml once daily Week 3 and onward (if […]

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 12 System organ class Frequency Very common Common Uncommon Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus - Dysplastic naevus Blood and lymphatic system disorders - Eosinophilia - Metabolism and nutritional disorders - - Appetite disorder, thirst Psychiatric disorders - Depression, insomnia, disturbance in sexual arousal, libido increased Sleep disorder, nightmares, libido decreased Nervous system disorders Headache Dizziness Somnolence, migraine, parosmia, dysguesia Eye disorders - - Scleral discolouration Ear and labyrinth disorders - - Vertigo Vascular disorders - - Hot flush Respiratory, thoracic and mediastinal disorders - - Yawning, rhinorrhoea, cough Gastrointestinal disorders Nausea, vomiting Diarrhoea, abdominal pain, dry mouth, dyspepsia, constipation, gastrooesophageal reflux disease, flatulence Abdominal distension, abdominal discomfort, salivary hypersecretion Hepatobiliary disorders - Alanine aminotransferase increased Aspartate aminotransferase increased, blood bilirubin increased, gamma- glutamyltransferase increased, hepatic enzyme increased, blood alkaline phosphatase increased Skin and subcutaneous tissue disorders Hyperpigmentation disordersa Pruritus, rash, dry skin, skin lesion, alopecia Erythema, skin striae, hyperhidrosis, lipodystrophy acquired, urticaria, skin exfoliation, hair colour changes, nail discolouration, acanthosis nigricans 13 System organ class Frequency Very common Common Uncommon Musculoskeletal and connective tissue disorders - Arthralgia, back pain, myalgia Musculoskeletal pain, muscle spasms, pain in extremity, blood creatine phosphokinase increased Reproductive system and breast disorders Spontaneous penile erectionb, erection increasedb Vulvovaginal discomfortc Female sexual arousal disorderc, genital pain, genital discomfort, genital disorder femalec, genital hyperaesthesia, dysmenorrhoeac General disorders and administrative site conditions Injection site reactionsa, fatigue Asthenia, pain Temperature intolerance, chills 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.

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. 10 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.

1.