Daybue and Daybue Stix

Daybue and Daybue Stix are used to treat Rett syndrome in adults and children 2 years and older. Rett syndrome is a rare, genetic neurological disorder caused by mutations on the X chromosome in a gene called MECP2. It occurs primarily in females, with symptoms usually presenting between 6 and 18 months of age.

Rett syndrome causes problems in brain function. Children with Rett syndrome experience loss of fine motor skills, impaired gross motor skills, and loss of communication skills (including eye contact). Symptoms may also include seizures, disorganized breathing patterns, scoliosis, and sleep disturbances.

Daybue contains trofinetide, a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The exact way by which Daybue works to treat Rett syndrome is not known, but it is thought to reduce inflammation and support synaptic function in the central nervous system.

It is not known if this medicine is safe and effective in children under 2 years of age.

Take Daybue or Daybue Stix exactly as your healthcare provider tells you to take it.

• If you have kidney problems, talk to your healthcare provider about the right dose of Daybue or Daybue Stix.
• If you take laxatives, stop taking them before starting treatment.
• Daybue or Daybue Stix may be given by mouth or through a gastrostomy (G) tube. If given through a gastrojejunal (GJ) tube, the G-port must be used.
• Daybue or Daybue Stix may be taken with or without food.
• Your pharmacist should provide an oral syringe or dosing cup to measure your prescribed dose of Daybue or the amount of liquid to mix with Daybue Stix powder. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.

If you are taking Daybue oral solution:

• Throw away any unused Daybue oral solution after 14 days of first opening the bottle.

If you are taking Daybue Stix for oral solution:

• Open each packet only when you are ready to use it.
• Daybue Stix powder must be dissolved in cold to room temperature water or water-based beverage (juice, tea, lemonade, or liquid hydration).
• Your healthcare provider will tell you how much cold-to-room-temperature water or a water-based beverage to use to dissolve the powder in each packet.
• Empty the entire contents of the Daybue Stix packets needed for your prescribed dose into the measured liquid. Do not attempt to use part of a packet.
• Stir until the powder is completely dissolved.
• After the powder is dissolved, take the prepared oral solution right away. Do not store for future use.

What happens if I vomit after taking Daybue or Daybue Stix?

If you vomit after taking a dose of Daybue or Daybue Stix, 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.

What happens if I miss a dose?

If you miss a dose of Daybue or Daybue Stix, skip that dose and take your next dose at your usual time. Do not take 2 doses to make up for the missed dose.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Daybue will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Daybue or Daybue Stix passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Most Common

The most common side effects of Daybue are diarrhea and vomiting.

Diarrhea

Diarrhea is a common side effect, and it 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. Your healthcare provider may ask you to increase the amount you drink or take anti-diarrheal medicine as needed.

Vomiting

Vomiting is a common side effect and can sometimes 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.

Other Side Effects

Weight loss

Daybue or Daybue Stix can cause weight loss. Tell your healthcare provider if you notice you are losing weight at any time during treatment.

These are not all the possible side effects. 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 the FDA at 1-800-FDA-1088.

Usual Adult and Pediatric Dose of Daybue or Daybue Stix for Rett Syndrome:

• 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.

Supplied as:

• Daybue: a pink to red, strawberry-flavored oral solution containing 200 mg per mL
• Daybue Stix powdered packets for oral solution: these require mixing with water before use. Strawberry flavored (5000 mg, 6000 mg, and 8000 mg).

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.

Especially tell your doctor if you take laxatives. Daybue and Daybue Stix can cause diarrhea, so you should stop taking laxatives before you start treatment.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Keep all medicines out of the reach of children and pets.

Daybue oral solution:

• Store the bottle in the refrigerator between 36°F and 46°F (2°C to 8°C). Do not freeze.
• Keep the oral solution bottle in an upright position.
• Keep the child-resistant cap on the bottle tightly closed.

Daybue Stix for oral solution:

• Store powder packets at room temperature between 68°F and 77°F (20°C to 25°C).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.

Active ingredient: trofinetide

Daybue oral solution inactive ingredients: FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose.

Daybue Stix for oral solution inactive ingredients: natural strawberry flavor and sucralose.