DAYBUE is now FDA Approved

The first and only approved treatment for Rett syndrome¹

Introducing DAYBUE [day-BYOO], a new prescription oral therapy for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.¹

DAYBUE will be available by the end of April 2023

We will begin accepting Prescription and Enrollment forms at that time.

Read Prescribing Information about DAYBUE

Download Prescribing Information

Read the Latest News about FDA-approved DAYBUE

The Acadia Connect team is here to support you and your patients through the journey ahead

The Acadia Connect team is here to support you through the journey ahead

Acadia Connect is a patient and family support program that connects you, your patients, and their family members with dedicated tools and resources in the treatment journey after patients have been prescribed DAYBUE.

Acadia Connect offers healthcare providers and practices support services in the following areas:

Access and coverage support services, including benefits investigations and information to assist with prior authorizations and appeals processes
Information on appropriate financial assistance options for eligible patients
Coordination of medication delivery to patients through AnovoRx Specialty Pharmacy
Support and education throughout the DAYBUE treatment journey

Acadia Connect offers your patients and caregivers support services in the following areas:

Help to understand and verify insurance coverage
Information on appropriate financial assistance options
Support and education throughout the DAYBUE treatment journey
Coordination with AnovoRx Specialty Pharmacy for timely delivery of DAYBUE

GET YOUR PATIENTS STARTED IN 3 STEPS:

Download DAYBUE
Prescription and Enrollment Form
Available for download April 17, 2023

Fax the completed form to Acadia Connect at 1-888-385-2748

You will receive a receipt of enrollment and a Nurse Care Coordinator will reach out within 24 hours.

By the end of April 2023:

Acadia Connect will begin accepting Prescription and Enrollment Forms.

Call Acadia Connect at 1-844-737-2223, Monday to Friday, 8AM to 8PM ET, or visit acadiaconnect.com to learn more about our personalized support program designed to help meet the needs of your patients taking DAYBUE.

Important Safety Information

Warnings and Precautions
- Diarrhea: In a 12-week study and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In the 12-week study, antidiarrheal medication was used in 51% of patients treated with DAYBUE.
  Patients should stop taking laxatives before starting DAYBUE. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE if severe diarrhea occurs or if dehydration is suspected.
- Weight Loss: In the 12-week study, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
Adverse Reactions: The common adverse reactions (≥5% for DAYBUE-treated patients and at least 2% greater than in placebo) reported in the 12-week study were diarrhea (82% vs 20%), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), anxiety (8% vs 1%), decreased appetite (8% vs 2%), fatigue (8% vs 2%), and nasopharyngitis (5% vs 1%).
Drug Interactions: Effect of DAYBUE on other Drugs
- DAYBUE is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE. Closely monitor when DAYBUE is used in combination with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities.
- Plasma concentrations of OATP1B1 and OATP1B3 substrates may be increased if given concomitantly with DAYBUE. Avoid the concomitant use of DAYBUE with OATP1B1 and OATP1B3 substrates for which a small change in substrate plasma concentration may lead to serious toxicities.
Use in Specific Population: Renal Impairment
- DAYBUE is not recommended for patients with moderate or severe renal impairment.

DAYBUE is available as an oral solution (200mg/mL).

Indication

DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

Please read the full Prescribing Information.

Important Safety Information

Warnings and Precautions
- Diarrhea: In a 12-week study and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In the 12-week study, antidiarrheal medication was used in 51% of patients treated with DAYBUE.
  Patients should stop taking laxatives before starting DAYBUE. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE if severe diarrhea occurs or if dehydration is suspected.
- Weight Loss: In the 12-week study, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
Adverse Reactions: The common adverse reactions (≥5% for DAYBUE-treated patients and at least 2% greater than in placebo) reported in the 12-week study were diarrhea (82% vs 20%), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), anxiety (8% vs 1%), decreased appetite (8% vs 2%), fatigue (8% vs 2%), and nasopharyngitis (5% vs 1%).
Drug Interactions: Effect of DAYBUE on other Drugs
- DAYBUE is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE. Closely monitor when DAYBUE is used in combination with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities.
- Plasma concentrations of OATP1B1 and OATP1B3 substrates may be increased if given concomitantly with DAYBUE. Avoid the concomitant use of DAYBUE with OATP1B1 and OATP1B3 substrates for which a small change in substrate plasma concentration may lead to serious toxicities.
Use in Specific Population: Renal Impairment
- DAYBUE is not recommended for patients with moderate or severe renal impairment.

DAYBUE is available as an oral solution (200mg/mL).

Indication

DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

Please read the full Prescribing Information.

Reference: 1. Acadia Pharmaceuticals Inc. DAYBUE [Package Insert]. San Diego, CA, 2023.

DAYBUE is now FDA Approved

The first and only approved treatment for Rett syndrome1

Introducing DAYBUE [day-BYOO], a new prescription oral therapy for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.1

DAYBUE will be available by the end of April 2023

DAYBUE Webinar for Healthcare Professionals

The Acadia Connect team is here to support you and your patients through the journey ahead

The Acadia Connect team is here to support you through the journey ahead

GET YOUR PATIENTS STARTED IN 3 STEPS:

Important Safety Information

Indication

Important Safety Information

Indication

Welcome to the DAYBUE (trofinetide) website. This information is intended for US healthcare professionals only.

Introducing DAYBUE™ Webinar for Caregivers

DAYBUE Webinar for Healthcare Professionals

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The first and only approved treatment for Rett syndrome¹

Introducing DAYBUE [day-BYOO], a new prescription oral therapy for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.¹