setmelanotide at a glance
Medicine class
Selective melanocortin-4 receptor agonist
How it is given
Injection under the skin of the abdomen, with sites rotated
Specialist oversight
Prescribed and supervised by clinicians experienced in rare genetic or hypothalamic obesity
What is setmelanotide used for?
Licensed uses include:
Obesity and hunger associated with acquired hypothalamic obesity due to hypothalamic injury or impairment, in adults and children aged 4 years and over.
Obesity and hunger associated with genetically confirmed Bardet–Biedl syndrome, in adults and children aged 2 years and over.
Obesity and hunger associated with genetically confirmed biallelic loss-of-function POMC deficiency, including PCSK1 deficiency, or biallelic LEPR deficiency, in adults and children aged 2 years and over.
How does setmelanotide work?
Setmelanotide activates melanocortin-4 receptors in the brain, which help regulate hunger, fullness and energy expenditure. It can restore signalling that reduces excessive hunger and food intake. Its lesser activity at melanocortin-1 receptors can darken pigmentation.
setmelanotide preparations and strengths
Injection
Route: Parenteral
Strengths: 10 mg/mL
How to take setmelanotide
A healthcare professional should teach the patient or carer how to prepare and inject it. Food does not affect administration.
Inject under the skin of the abdomen and use a different abdominal site each time.
Do not inject into red, swollen or irritated skin.
Use a new syringe for every injection and put used syringes in a sharps bin.
Do not use solution that is cloudy, contains particles, is expired or has been exposed to temperatures above 30°C.
Follow the prescribed instructions exactly.
setmelanotide side effects
Common or expected effects
- Darkening or other pigmentation changes affecting the skin, hair, nails or mouth
- New moles or darkening of existing moles
- Injection-site redness, itching, swelling, bruising or pain
- Feeling or being sick, headache or tiredness
- Spontaneous or increased penile erections
- Dizziness, diarrhoea, abdominal discomfort or constipation
Get urgent medical advice
- An erection lasting longer than 4 hours requires emergency assessment.
- Suicidal thoughts or behaviour require urgent assessment, particularly if the person cannot stay safe.
- Rapid heartbeat, rapid breathing or confusion in a child aged 2 years may indicate benzyl-alcohol accumulation and needs urgent medical assessment.
setmelanotide in pregnancy
There are no human pregnancy data. Setmelanotide should not normally be started during pregnancy or while trying to conceive because weight loss during pregnancy may harm the fetus. If pregnancy occurs during treatment, contact the specialist promptly.
setmelanotide while breastfeeding
It is unknown whether setmelanotide enters human breast milk, and risk to the infant cannot be excluded. The prescriber should weigh the benefits of breastfeeding against those of treatment. Its benzyl alcohol content also requires consideration.
setmelanotide interactions
Formal interaction studies have not been performed, though laboratory data suggest low potential for common pharmacokinetic interactions. Tell the specialist about all prescribed, non-prescribed and herbal products. Medicines affected by changes in body weight, metabolism, cortisol or nutritional status may need closer review.
Common questions about setmelanotide
Answers are fully visible for fast scanning and source review.
Is setmelanotide a general weight-loss injection?
No. It is licensed for obesity and excessive hunger caused by specific rare genetic disorders or acquired hypothalamic injury and requires specialist supervision.
Does setmelanotide require genetic testing?
Genetic confirmation is required for Bardet–Biedl syndrome and biallelic POMC, PCSK1 or LEPR deficiency. Acquired hypothalamic obesity is established from hypothalamic injury or impairment.
Why can setmelanotide darken the skin?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.