DAYBUE

Generic Name/API: trofinetide

Manufacturer: Acadia Pharmaceuticals Inc.

Dosage Forms & Strength:
• Oral solution: 200 mg/mL

Storage:
Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
Keep the child-resistant cap tightly closed.
Discard any unused DAYBUE oral solution after 14 days of first opening the bottle.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
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.

Important Safety Information and Indication
What are the possible side effects of DAYBUE?
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). Before starting treatment with DAYBUE, stop taking laxatives. 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.
The most common side effects of DAYBUE were diarrhea and vomiting. Other side effects include fever, seizure, anxiety, decreased appetite, tiredness, and the common cold. 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.
What should I tell my healthcare provider before taking DAYBUE?
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 how the other medicines work and can cause serious side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also call Acadia Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

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

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