Active Ingredient: Setmelanotide
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:
For:
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.
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:
| Week | Daily dose |
|---|---|
| Weeks 1-2 | 1 mg once daily |
| Week 3 and onward | 2 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 |
If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.
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.
For:
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.
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:
| Week | Daily dose |
|---|---|
| Weeks 1-2 | 0.5 mg once daily |
| Weeks 3-5 | 1 mg once daily |
| Week 6 and onward | 2 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.
If a dose is missed, the once daily regimen should be resumed at the dose prescribed with the next scheduled dose.
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.
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