Active Ingredient: Setmelanotide
Setmelanotide is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 3 milligrams setmelanotide, once daily.
The dose titration in the table below should be followed. Dose titration may be performed both upward and downward based on individual tolerability and clinical response. Dose can be reduced to 0.25 mg if needed.
Dose titration in adults:
| Week | Daily dose |
| Week 1 | 0.5 mg once daily |
| Week 2 (if 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 (if 1 mg dose is well tolerated) | 2 mg once daily |
| Week 4 and onward (if clinical response is insufficient and 2 mg dose 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.
Although no apparent age-related differences have been observed, data obtained from elderly patients is not sufficient to determine whether they respond differently from younger patients. There is no evidence indicating any special precautions are required for treating an elderly population.
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:
Regimen A, in the case that patient age in years is ≥ 6 :
Disc oral, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, disc oral, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, disc oral, 2 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, disc oral, 3 milligrams setmelanotide, once daily.
Regimen B, in the case that patient age in years is ≥ 4 and patient age in years is < 6 and patient weight is < 20 kg :
Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.5 milligrams setmelanotide, once daily.
Regimen C, in the case that patient age in years is ≥ 4 and patient age in years is < 6 and patient weight is ≥ 20 kg and patient weight is < 25 kg :
Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily.
Regimen D, in the case that patient age in years is ≥ 4 and patient age in years is < 6 and patient weight is ≥ 25 kg and patient weight is < 30 kg :
Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2.5 milligrams setmelanotide, once daily.
Regimen E, in the case that patient age in years is ≥ 4 and patient age in years is < 6 and patient weight is ≥ 30 kg :
Subcutaneous, 0.5 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2 milligrams setmelanotide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 3 milligrams setmelanotide, once daily.
The dose titration in Table 1 should be followed. Dose titration may be performed both upward and downward based on individual tolerability and clinical response. Dose can be reduced to 0.25 mg if needed.
Table 1. Dose titration in children 6 years of age and above:
| Week | Daily dose |
| Week 1 | 0.5 mg once daily |
| Week 2 (if 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 (if 1 mg dose is well tolerated) | 2 mg once daily |
| Week 4 and onward (if clinical response is insufficient and 2 mg dose is well tolerated) | 3 mg once daily |
The dose titration in Table 2 should be followed depending upon patient weight. Dose titration may be performed both upward and downward based on individual tolerability and clinical response. Dose can be reduced to 0.25 mg if needed.
Table 2. Dose titration in children from 4 to less than 6 years of age:
| Patient weight/treatment week | Daily dose |
| <20 kg | |
| Week 1 | 0.5 mg once daily |
| Week 2 (if clinical response is insufficient and 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 and onward (if clinical response is insufficient and 1 mg dose is well tolerated) | 1.5 mg once daily |
| 20 - <25 kg | |
| Week 1 | 0.5 mg once daily |
| Week 2 (if clinical response is insufficient and 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 (if clinical response is insufficient and 1 mg dose is well tolerated) | 1.5 mg once daily |
| Week 4 and onward (if clinical response is insufficient and 1.5 mg dose is well tolerated) | 2 mg once daily |
| 25 - <30 kg | |
| Week 1 | 0.5 mg once daily |
| Week 2 (if clinical response is insufficient and 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 (if clinical response is insufficient and 1 mg dose is well tolerated) | 1.5 mg once daily |
| Week 4 (if clinical response is insufficient and 1.5 mg dose is well tolerated) | 2 mg once daily |
| Week 5 and onward (if clinical response is insufficient and 2 mg dose is well tolerated) | 2.5 mg once daily |
| ≥30 kg | |
| Week 1 | 0.5 mg once daily |
| Week 2 (if clinical response is insufficient and 0.5 mg dose is well tolerated) | 1 mg once daily |
| Week 3 (if clinical response is insufficient and 1 mg dose is well tolerated) | 2 mg once daily |
| Week 4 and onward (if clinical response is insufficient and 2 mg dose 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.
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