Daybue Stix 5000 mg/1
trofinetide · FOR SOLUTION · Acadia Pharmaceuticals Inc.
Trofinetide (Daybue Stix) is an oral solution used to treat Rett syndrome, a rare genetic neurological disorder that primarily affects girls. This medication works by inhibiting a specific enzyme involved in drug metabolism in the body.
Key Facts
- Brand Name
- Daybue Stix
- Generic Name
- trofinetide
- NDC Code (Product)
63090-663- Manufacturer
- Acadia Pharmaceuticals Inc.
- Strength
- 5000 mg/1
- Dosage Form
- FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA219884
- Drug Class
- Cytochrome P450 3A4 Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
- Marketing Start
- 12/11/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage is twice daily, morning and evening, according to patient weight. DAYBUE or DAYBUE STIX can be given with or without food. ( 2.1 ) Patient Weight Recommended Dosage 9 kg to less than 12 kg 5,000 mg twice daily 12 kg to less than 20 kg 6,000 mg twice daily 20 kg to less than 35 kg 8,000 mg twice daily 35 kg to less than 50 kg 10,000 mg twice daily 50 kg or more 12,000 mg twice daily Can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. ( 2.1 ) See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. ( 2.3 ) See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.6 , 8.6 ) 2.1 Recommended Dosage The recommended dosage of DAYBUE or DAYBUE STIX is based on patient weight as shown in Table 1 . Administer DAYBUE or DAYBUE STIX orally or via gastrostomy (G) tube twice daily, in the morning and evening, with or without food. Doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. Table 1 Recommended Dosage of DAYBUE or DAYBUE STIX in Patients …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use. ( 7.1 ) 7.1 Effect of DAYBUE and DAYBUE STIX on Other Drugs CYP3A and/or P-gp Substrates Closely monitor patients when DAYBUE or DAYBUE STIX is administered concomitantly with sensitive CYP3A and/or P-gp substrates where minimal increases in the plasma concentration of these substrates may lead to serious adverse reactions. Trofinetide, a weak inhibitor of CYP3A and an inhibitor of P-gp, increased the plasma concentrations of CYP3A and/or P-gp substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions associated with these substrates.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Diarrhea [see Warnings and Precautions (5.1) ] Weight Loss [see Warnings and Precautions (5.2) ] Vomiting [see Warnings and Precautions (5.3) ] The most common adverse reactions (that occurred in at least 10% of DAYBUE-treated patients and at least 2% greater than in placebo) were diarrhea and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acadia Pharmaceuticals Inc. at 1-844-422-2342 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled and uncontrolled trials in patients with Rett syndrome, 260 patients ages 2 to 40 years were treated with DAYBUE, including 112 patients treated for more than 6 months, 92 patients treated for more than 1 year, and 44 patients treated for more than 2 years. The safety of DAYBUE STIX has been established from an adequate,…
Frequently Asked Questions
What is Daybue Stix used for?
Trofinetide (Daybue Stix) is an oral solution used to treat Rett syndrome, a rare genetic neurological disorder that primarily affects girls. This medication works by inhibiting a specific enzyme involved in drug metabolism in the body.
Is Daybue Stix a controlled substance?
Daybue Stix is not classified as a controlled substance by the DEA.
What is the generic name for Daybue Stix?
The generic name for Daybue Stix is trofinetide. There are 1 other brand versions of trofinetide.
What is the NDC code for Daybue Stix 5000 mg/1?
The NDC (National Drug Code) for Daybue Stix 5000 mg/1 is 63090-663, listed by Acadia Pharmaceuticals Inc..