DailyMed / DAYBUE and DAYBUE STIX exact label
- Product / population
- Trofinetide DAYBUE 200 mg/mL oral solution and DAYBUE STIX oral powder for Rett syndrome in patients aged 2 years and older. The selected dosing table begins at 9 kg.
- Renal measure
- Adult eGFR, mL/min; pediatric eGFR, mL/min/1.73 m2
Selected sections only. Source mirror and underlying label are not independent confirmations.
Renal dosing, restrictions and evidence limits
Mild impairment (eGFR 60-89): no adjustment. Moderate impairment (30-59) uses these twice-daily amounts: 9 to <12 kg, 2500 mg; 12 to <20 kg, 3000 mg; 20 to <35 kg, 4000 mg; 35 to <50 kg, 5000 mg; 50 kg or more, 6000 mg. Severe impairment below 30: use is not recommended.
The table uses eGFR in mL/min for adults and mL/min/1.73 m2 for pediatric patients. For doses below 5000 mg, the label recommends DAYBUE solution; do not use partial STIX packets. Severe diarrhea, dehydration, weight loss or persistent vomiting may require interruption, reduction or discontinuation. These are selected renal instructions, not the complete weight-based prescribing information.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=67e6f2d9-21f6-466f-9def-826c6a4b8257