Trofinetide

What is Trofinetide?[edit | edit source]

Trofinetide (Daybue), is an analog of glycine-proline-glutamate (GPE), a protein that occurs naturally in the brain.

Trofinetide

Trofinetide structure

Trofinetide (Daybue) is a prescription medicine used to treat Rett syndrome in adults and children 2 years of age and older.

The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:

Recommended dosage: Administer Daybue orally twice daily, in the morning and evening, according to patient weight as shown:

Administration:

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.
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.

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

Less common, but serious side effects may include:

Most patients experience diarrhea during treatment with Daybue. Advise patients to stop laxatives before starting Daybue. If diarrhea occurs, patients should start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider. Interrupt, reduce dose, or discontinue Daybue if severe diarrhea occurs or if dehydration is suspected.
Weight loss may occur in patients treated with Daybue. Monitor weight and interrupt, reduce dose, or discontinue Daybue if significant weight loss occurs.
Advise the caregiver or patient that Daybue can cause vomiting and if vomiting occurs after Daybue administration, do not take an additional dose, but continue with the next scheduled dose.
Advise the caregiver or patient that Daybue may be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. Daybue may be taken with or without food.
Instruct the caregiver or patient to obtain a calibrated measuring device, such as an oral syringe or oral dosing cup, from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup is not an adequate measuring device.
Instruct the caregiver or patient to discard any unused Daybue after 14 days of first opening the bottle.
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.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

There are no adequate data on the developmental risks associated with the use of Daybue in pregnant women.
It is not known if Daybue will harm your unborn baby.

The safety and effectiveness of Daybue for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
Safety and effectiveness in pediatric patients less than 2 years of age have not been established.

Active ingredient: trofinetide
Inactive ingredients: FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose.

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.

Trofinetide Resources
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