Trofinetide

Generic name: Trofinetide
Brand names: Daybue
Dosage form: oral liquid (200 mg/mL)
Drug class: Miscellaneous central nervous system agents

Usage of Trofinetide

Trofinetide is for use in adults and children at least 2 years old to treat Rett syndrome.

Trofinetide may also be used for purposes not listed in this medication guide.

Trofinetide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Trofinetide may cause serious side effects. Call your doctor at once if you have:

severe diarrhea;

weight loss; or

dehydration--dizziness, confusion, feeling very thirsty, less urination.

Common side effects may include diarrhea or vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Trofinetide

Tell your doctor if you have or have ever had:

if you use a laxative; or

kidney disease.

It is not known if trofinetide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using trofinetide.

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How to use Trofinetide

Usual Adult Dose for Rett Syndrome:

Oral:18 years or older:-Weight 9 to less than 12 kg: 5,000 mg (25 mL) orally twice a day-Weight 12 to less than 20 kg: 6,000 mg (30 mL) orally twice a day-Weight 20 to less than 35 kg: 8,000 mg (40 mL) orally twice a day-Weight 35 to less than 50 kg: 10,000 mg (50 mL) orally twice a day-50 kg or more: 12,000 mg (60 mL) orally twice a dayComments:-This drug can be taken with or without food twice daily, in the morning and evening.-If a dose is missed, an additional dose should not be taken to make up for the missed dose. Instead, wait and continue with the next scheduled dose.-In the event of vomiting, do not take another dose to make up for that dose. Wait and take the following dose as scheduled.Use: For the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older

Usual Pediatric Dose for Rett Syndrome:

Oral:2 to less than 18 years:-Weight 9 to less than 12 kg: 5,000 mg (25 mL) orally twice a day-Weight 12 to less than 20 kg: 6,000 mg (30 mL) orally twice a day-Weight 20 to less than 35 kg: 8,000 mg (40 mL) orally twice a day-Weight 35 to less than 50 kg: 10,000 mg (50 mL) orally twice a day-50 kg or more: 12,000 mg (60 mL) orally twice a dayComments:-This drug can be taken with or without food twice daily, in the morning and evening.-If a dose is missed, an additional dose should not be taken to make up the missed dose. Instead, wait and continue with the next scheduled dose.-In the event of vomiting, do not take another dose to make up for that dose. Wait and take the following dose as scheduled.Use: For the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What other drugs will affect Trofinetide

Other drugs may affect trofinetide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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