• Miscellaneous neurodegenerative disorders

Daybue Generic Name & Formulations

General Description

Trofinetide 200mg/mL; oral soln; strawberry flavor.

Pharmacological Class

Synthetic tripeptide glycine-proline-glutamate (GPE).

How Supplied

Oral soln—450mL


Generic Availability


Mechanism of Action

The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

Daybue Indications


Rett syndrome. 

Daybue Dosage and Administration

Adults and Children

<2yrs: not established. Use calibrated measuring device. Administer orally or via G tube twice daily (AM & PM); doses via GJ tube must be given through G-port. ≥2yrs: 9–<12kg: 5000mg (25mL) twice daily; 12–<20kg: 6000mg (30mL) twice daily; 20–<35kg: 8000mg (40mL) twice daily; 35–<50kg: 10000mg (50mL) twice daily; ≥50kg: 12000mg (60mL) twice daily. 

Daybue Contraindications

Not Applicable

Daybue Boxed Warnings

Not Applicable

Daybue Warnings/Precautions


Discontinue any laxatives prior to initiation. Interrupt, reduce dose, or discontinue if severe diarrhea occurs, dehydration suspected or significant weight loss occurs. Consider antidiarrheal, monitor hydration, and increase fluids, if needed. Monitor weight. Moderate or severe renal impairment: not recommended. Elderly: monitor renal function. Pregnancy. Nursing mothers.

Daybue Pharmacokinetics


The time to maximum drug concentration (Tmax): ~2 to 3 hours. 


Apparent volume of distribution in healthy patients: ~80 L.

Plasma protein bound: <6%.


Renal. (~80%), fecal. Half-life: ~1.5 hours. 

Daybue Interactions


May potentiate concomitant CYP3A4 substrates; monitor closely (esp. with CYP3A4 sensitive substrates). May potentiate OATP1B1 and OATP1B3 substrates; avoid concomitant use. 

Daybue Adverse Reactions

Adverse Reactions

Diarrhea, vomiting, fever, seizure, decreased appetite. 

Daybue Clinical Trials

See Literature

Daybue Note

Not Applicable

Daybue Patient Counseling

See Literature