Active Ingredient: Trofinetide
Trofinetide is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 9 kg and patient weight is ≤ 12 kg, oral, 5,000 milligrams trofinetide, 2 times daily.
Regimen B: In case that patient weight is ≥ 12 kg and patient weight is ≤ 20 kg, oral, 6,000 milligrams trofinetide, 2 times daily.
Regimen C: In case that patient weight is ≥ 20 kg and patient weight is ≤ 35 kg, oral, 8,000 milligrams trofinetide, 2 times daily.
Regimen D: In case that patient weight is ≥ 35 kg and patient weight is ≤ 50 kg, oral, 10,000 milligrams trofinetide, 2 times daily.
Regimen E: In case that patient weight is ≥ 50 kg, oral, 12,000 milligrams trofinetide, 2 times daily.
Administer trofinetide orally twice daily, in the morning and evening, according to patient weight as shown in the following table.
Recommended dosage of trofinetide in patients 2 years of age and older:
| Patient weight | Trofinetide dosage |
|---|---|
| 9 kg to less than 12 kg | 5,000 mg twice daily |
| 12 kg to less than 20 kg | 6,000 mg twice daily |
| 20 kg to less than 35 kg | 8,000 mg twice daily |
| 35 kg to less than 50 kg | 10,000 mg twice daily |
| 50 kg or more | 12,000 mg twice daily |
If a dose of trofinetide is missed, the next dose should be taken as scheduled. Doses should not be doubled.
If vomiting occurs after trofinetide administration, an additional dose should not be taken. Instead, continue with the next scheduled dose.
Advise patients to stop laxatives before starting trofinetide. Interrupt, reduce the dosage, or discontinue trofinetide if severe diarrhea occurs, if dehydration is suspected, or if significant weight loss occurs.
Trofinetide can be taken with or without food.
Administer trofinetide orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.
A calibrated measuring device, such as an oral syringe or oral dosing cup, should be obtained from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup is not an adequate measuring device.
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