PATIENT INFORMATION DAYBUE™ (day-BYOO) (trofinetide) oral solution
This Patient Information has been approved by the U.S. Food and Drug Administration	Approved 9/2024
What is DAYBUE? DAYBUE is a prescription medicine used to treat Rett syndrome in adults and children 2 years of age and older. It is not known if DAYBUE is safe and effective in children under 2 years of age.
Before taking DAYBUE, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems. are pregnant or plan to become pregnant. It is not known if DAYBUE will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if DAYBUE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking DAYBUE. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking DAYBUE with certain medicines 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 provider and pharmacist when you get a new medicine.
How should I take DAYBUE? Take DAYBUE exactly as your healthcare provider tells you to take it. If you take laxatives, stop taking them before starting treatment with DAYBUE. Your healthcare provider may change your dose or stop treatment with DAYBUE if needed. Your pharmacist should provide an oral syringe or dosing cup that is needed to measure your prescribed dose. Do not use a household measuring cup. DAYBUE may be taken by mouth or given through a gastrostomy (G) tube. If DAYBUE is given through a gastrojejunal (GJ) tube, the G-port must be used. DAYBUE may be taken with or without food. Throw away any unused DAYBUE after 14 days of first opening the bottle. If you vomit after taking a dose of DAYBUE, do not take another dose to make up for that dose. Wait and take the next dose at your usual time. Call your healthcare provider 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.
What are the possible side effects of DAYBUE? DAYBUE may cause side effects, including: Diarrhea. Diarrhea is a common side effect of DAYBUE that can sometimes be severe. Diarrhea may cause you to lose too much water from your body (dehydration). Tell your healthcare provider if you have diarrhea while taking DAYBUE. Your healthcare provider may ask you to increase the amount you drink or take antidiarrheal medicine as needed. Weight loss. DAYBUE can cause weight loss. Tell your healthcare provider if you notice you are losing weight at any time during treatment with DAYBUE. Vomiting. Vomiting is a common side effect of DAYBUE. Sometimes vomit can get into your lungs (aspiration), which could cause an infection (aspiration pneumonia). Tell your healthcare provider if you have severe vomiting or if vomiting happens often. The most common side effects of DAYBUE include diarrhea and vomiting. These are not all the possible side effects of DAYBUE. Tell your healthcare provider if you have any side effects that bother you or do not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store DAYBUE? Store DAYBUE in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Keep DAYBUE in an upright position. Keep the child-resistant cap tightly closed. Keep DAYBUE and all medicines out of the reach of children.
General information about the safe and effective use of DAYBUE. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DAYBUE for a condition for which it was not prescribed. Do not give DAYBUE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about DAYBUE that is written for health professionals.

What are the ingredients in DAYBUE? Active ingredient: trofinetide Inactive ingredients: FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose. Marketed by Acadia Pharmaceuticals Inc., San Diego, CA 92130 USA DAYBUE is a trademark of Acadia Pharmaceuticals Inc. ©2024 Acadia Pharmaceuticals Inc. All rights reserved. For more information, go to www.daybue.com or call 1-844-422-2342.

trofinetide

Product monograph

Family members