Obesity associated with leptin receptor deficiency

Active Ingredient: Setmelanotide

Indication for Setmelanotide

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Setmelanotide is indicated for the treatment of obesity and the control of hunger associated with deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.

For this indication, competent medicine agencies globally authorize below treatments:

1 mg once daily for 2 weeks and thereafter 1-3 mg once daily

For:

Dosage regimens

Subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, subcutaneous, 2.5 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, in case that there is poor response to treatment, subcutaneous, 3 milligrams setmelanotide, once daily. The maximum allowed total dose is 3 milligrams setmelanotide daily.

Detailed description

For adults and children 12 to 17 years of age, the starting dose is a 1 mg once daily subcutaneous injection for 2 weeks. After 2 weeks, if setmelanotide is well-tolerated, the dose can be increased to a 2 mg once daily subcutaneous injection. If dose escalation is not tolerated, patients may maintain administration of the 1 mg once daily dose.

If additional weight loss is desired in adult patients, the dose can be increased to a 2.5 mg once daily subcutaneous injection. If the 2.5 mg once daily dose is well-tolerated, the dose can be increased to 3 mg once daily.

In patients aged 12 to 17 years, if weight remains above the 90th percentile with the 2 mg once daily subcutaneous injection and additional weight loss is desired, the dose may be increased to 2.5 mg with a maximum dose of 3 mg once daily.

Dose titration in adults and paediatric patients 12 years of age or more:

WeekDaily dose
Weeks 1-21 mg once daily
Week 3 and onward2 mg once daily
If clinical response is insufficient and 2 mg dose
once daily is well tolerated
2.5 mg once daily
If clinical response is insufficient and 2.5 mg dose
once daily is well tolerated
3 mg once daily

Missed dose

If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.

Dosage considerations

Setmelanotide should be injected once daily, at the beginning of the day (to maximise hunger reduction during awake period), without regard to the timing of meals.

Setmelanotide should be injected subcutaneously in the abdomen, alternating the abdominal area each day.

0.5 mg once daily for 2 weeks and thereafter 0.5-2.5 mg once daily

For:

Dosage regimens

Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily, over the duration of 2 weeks. Afterwards, in case that there is poor response to treatment, subcutaneous, 2.5 milligrams setmelanotide, once daily. The maximum allowed total dose is 2.5 milligrams setmelanotide daily.

Detailed description

For patients aged 6 to <12 years, the starting dose is a 0.5 mg once daily subcutaneous injection for 2 weeks. If tolerated after 2 weeks, the dose can be increased to 1 mg once daily. If dose escalation is not tolerated, paediatric patients may maintain administration of the 0.5 mg once daily dose. If the 1 mg dose is tolerated after 2 weeks, the dose can be increased to 2 mg once daily. If weight remains above the 90th percentile with the 2 mg once daily subcutaneous injection and additional weight loss is desired, the dose may be increased to 2.5 mg once daily.

Dose titration for paediatric patients from 6 to <12 years of age:

WeekDaily dose
Weeks 1-20.5 mg once daily
Weeks 3-51 mg once daily
Week 6 and onward2 mg once daily
If clinical response is insufficient and 2 mg dose
once daily is well tolerated
2.5 mg once daily

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.

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 deficiency obesity will return.

Missed dose

If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.

Dosage considerations

Setmelanotide should be injected once daily, at the beginning of the day (to maximise hunger reduction during awake period), without regard to the timing of meals.

Setmelanotide should be injected subcutaneously in the abdomen, alternating the abdominal area each day.

Active ingredient

Setmelanotide

Setmelanotide is a selective MC4 receptor agonist. MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure. In genetic forms of obesity associated with insufficient activation of the MC4 receptor, setmelanotide is believed to re-establish MC4 receptor pathway activity to reduce hunger and promote weight loss through decreased caloric intake and increased energy expenditure.

Read more about Setmelanotide

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