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ALIMENTARY TRACT AND METABOLISM › ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS › ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS › Centrally acting antiobesity products
setmelanotide
A08AA12
Forms & Strengths
- Subcutaneous injection: 10 mg/mL in a 1 mL multidose vial
Adult Dosing
- Initial: 2 mg (0.2 mL) subcutaneously once daily for 2 weeks
- Maintenance: Increase to 3 mg (0.3 mL) once daily if tolerated; reduce to 1 mg (0.1 mL) once daily if significant adverse effects occur
Pediatric Dosing
- Patients aged 6 years and older: Initial 1 mg (0.1 mL) subcutaneously once daily for 2 weeks
- Maintenance: Increase to 2 mg once daily; may adjust between 1 mg and 3 mg daily based on efficacy and tolerability
Indications
- Chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency
- Chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to Bardet-Biedl syndrome
Mechanism of Action
- Selective agonist of the melanocortin-4 (MC4) receptor
- Restores melanocortin pathway signaling in the hypothalamus, which regulates hunger, satiety, and energy expenditure
Contraindications
- Hypersensitivity to setmelanotide or any of its components
- Pregnancy
Adverse Reactions
- Injection site reactions
- Skin hyperpigmentation
- Nausea
- Headache
- Diarrhea
- Abdominal pain
- Fatigue
- Depression and suicidal ideation
- Spontaneous penile erections in males
Drug Interactions
- May decrease systemic exposure of concomitant oral medications due to delayed gastric emptying
- Use caution with CNS-active agents due to risks of depression and neuropsychiatric changes
Curated Content: Needs Vetting Before Put to Clinical Use