Drug Detail:Daybue (Trofinetide)
Generic Name: trofinetide 200mg in 1mL
Dosage Form: oral solution
Drug Class: Miscellaneous central nervous system agents
Drug Detail:Daybue (Trofinetide)
Generic Name: trofinetide 200mg in 1mL
Dosage Form: oral solution
Drug Class: Miscellaneous central nervous system agents
Administer DAYBUE orally twice daily, in the morning and evening, according to patient weight as shown in Table 1. DAYBUE can be taken with or without food.
Patient Weight | DAYBUE Dosage | DAYBUE Volume |
---|---|---|
9 kg to less than 12 kg | 5,000 mg twice daily | 25 mL twice daily |
12 kg to less than 20 kg | 6,000 mg twice daily | 30 mL twice daily |
20 kg to less than 35 kg | 8,000 mg twice daily | 40 mL twice daily |
35 kg to less than 50 kg | 10,000 mg twice daily | 50 mL twice daily |
50 kg or more | 12,000 mg twice daily | 60 mL twice daily |
Administer DAYBUE 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.
Discard any unused DAYBUE oral solution after 14 days of first opening the bottle [see How Supplied/Storage and Handling (16.2)].