Patient Medication Information: uses, side effects, how to take - Daybue
What DAYBUE is used for:
DAYBUE is a prescription medication used to treat Rett syndrome in:
- adults (18 years of age and older); and
children (2 years of age and older) weighing at least 9 kg.
How DAYBUE works:
DAYBUE is a synthetic version of the terminal portion of a naturally occurring compound found in the brain called insulin-like growth factor 1. It is known as an “analog of N-terminal tripeptide of insulin-like growth factor 1”. The exact way it works is not known.
The ingredients in DAYBUE are:
Medicinal ingredient: trofinetide.
Non-medicinal ingredients: FD&C Red #40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavour, and sucralose.
DAYBUE comes in the following dosage form:
Solution; 200 mg/mL of trofinetide.
Do not use DAYBUE if:
- you are allergic to trofinetide or to any of the other ingredients in DAYBUE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DAYBUE. Talk about any health conditions or problems you may have, including if you:
- have kidney problems.
- have QT prolongation (irregular heart rhythm).
- take laxatives used to treat constipation. You will have to stop taking them before starting your treatment with DAYBUE.
Other warnings you should know about:
Testing and check-ups: Your healthcare professional may do certain tests before and during your treatment with DAYBUE. These tests may assess:
- the levels of potassium, calcium, magnesium, and electrolytes in your blood;
- your heartbeat; and/or
- your weight.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DAYBUE:
- midazolam, a medicine used to treat anxiety and cause drowsiness or sleepiness.
- loperamide, a medicine used to treat diarrhea.
DAYBUE may affect the way other medicines work and can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare professional and pharmacist when you get a new medicine.
How to take DAYBUE:
- Take DAYBUE exactly as your healthcare professional tells you to take it.
- DAYBUE should be taken two times a day, in the morning and in the evening.
- Your pharmacist should provide an oral syringe or oral dosing cup to measure your prescribed dose. Do not use a household measuring cup.
DAYBUE may be taken by:
- mouth;
- via a gastrostomy tube (G-tube); or
- via a gastrojejunal tube (GJ-tube) using a gastric port (G-port).
DAYBUE may be taken with or without food.
- If you vomit after taking a dose of DAYBUE, do not take another dose to make up for the dose that was vomited. Wait and take the next dose at your usual time. Call your healthcare professional if your vomiting does not stop.
- If you miss a dose of DAYBUE, skip that dose and take your next dose at your usual time. Do not take 2 doses to make up the missed dose.
Usual dose:
Your healthcare professional will decide the right dose for you based on your health, weight, and age. They may adjust or stop dose if needed.
Overdose:
If you think you, or a person you are caring for, have taken too much DAYBUE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss a dose of DAYBUE, take the missed dose as soon as possible. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not combine or double the dose.
Possible side effects from using DAYBUE:
These are not all the possible side effects you may have when taking DAYBUE. If you experience any side effects not listed here, tell your healthcare professional.
DAYBUE may cause side effects, including:
- fever
- irritability
- fatigue
- decreased appetite
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very common | |||
| Diarrhea | X | ||
| Vomiting | X | ||
| Weight loss | X | ||
| Common | |||
| Aspiration (swallowing or breathing something into the lungs): coughing, choking, shortness of breath, infection of the lungs (e.g., aspiration pneumonia), wheezing, fever, or chest pain. | X | ||
| QT prolongation (irregular heart rhythm): dizziness, chest pain, shortness of breath, fainting, or palpitations. | X | ||
| Seizures (fit): loss of consciousness with uncontrollable shaking. | X | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder, and urethra): pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, or cloudy urine. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store DAYBUE in a refrigerator between 2-8°C. Do not freeze. The bottle should be stored in an upright position with the cap tightly closed.
- Discard any unused solution after 14 days of first opening the bottle.
- Keep out of reach and sight of children.
If you want more information about DAYBUE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (ca.acadia.com); or by calling 1-844-222-3421.
Acadia Pharmaceuticals Inc.
San Diego, CA 92130.
Imported and distributed by: Innomar Strategies Inc. Oakville, Ontario L6L 0C4.
Date of Authorization: 2025-09-04
DAYBUE is a registered trademark of Acadia Pharmaceuticals Inc.
©2025 Acadia Pharmaceuticals Inc. All rights reserved.