Daybue Oral Solution Dosage

Generic name: trofinetide 200mg in 1mL
Dosage form: oral solution
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Drugs.com. Last updated on Oct 4, 2024.

Dosing Information

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.

Table 1 Recommended Dosage of DAYBUE in Patients 2 Years of Age and Older
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

Administration Information

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.

Dose Modification for Diarrhea or Weight Loss

Advise patients to stop laxatives before starting DAYBUE. Interrupt, reduce the dosage, or discontinue DAYBUE if severe diarrhea occurs, if dehydration is suspected, or if significant weight loss occurs.

Dose Modification for Vomiting After Administration

If vomiting occurs after DAYBUE administration, an additional dose should not be taken. Instead, continue with the next scheduled dose. Interrupt, reduce dose, or discontinue DAYBUE if vomiting is severe or occurs despite medical management.

Dosage Recommendations in Patients With Renal Impairment

No dosage adjustment is recommended for patients with mild renal impairment (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min for adult patients or 60 to 89 mL/min/1.73 m2 for pediatric patients). The recommended dosage of DAYBUE for patients with moderate renal impairment (eGFR 30 to 59 mL/min for adult patients or 30 to 59 mL/min/1.73 m2 for pediatric patients) is described in Table 2. DAYBUE is not recommended for patients with severe renal impairment (eGFR less than 30 mL/min for adult patients or less than 30 mL/min/1.73 m2 for pediatric patients).

Table 2 Recommended Dosage of DAYBUE in Patients With Moderate Renal Impairment
Patient Weight	DAYBUE Dosage	DAYBUE Volume
9 kg to less than 12 kg	2,500 mg twice daily	12.5 mL twice daily
12 kg to less than 20 kg	3,000 mg twice daily	15 mL twice daily
20 kg to less than 35 kg	4,000 mg twice daily	20 mL twice daily
35 kg to less than 50 kg	5,000 mg twice daily	25 mL twice daily
50 kg or more	6,000 mg twice daily	30 mL twice daily