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Daybue Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Oral soln—450mL
Manufacturer
Generic Availability
NO
Mechanism of Action
The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.
Daybue Indications
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
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
Absorption
The time to maximum drug concentration (Tmax): ~2 to 3 hours.
Distribution
Apparent volume of distribution in healthy patients: ~80 L.
Plasma protein bound: <6%.
Elimination
Renal. (~80%), fecal. Half-life: ~1.5 hours.
Daybue Interactions
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
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