Trofinetide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Trofinetide is a drug that is FDA approved for the treatment of Rett syndrome in adults and pediatric patients of age 2 years and older. Common adverse reactions include diarrhea and vomiting..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
DAYBUE is administered orally or via gastrostomy tube twice daily, in the morning and evening, according to patient weight and can be taken with or without food.
- 9-12 kg - 5000 mg twice daily (25ml twice daily)
- 12-20 kg - 6000 mg twice daily (30ml twice daily)
- 20-35 kg - 8000 mg twice daily (40ml twice daily)
- 35-50 kg - 10000 mg twice daily (50ml twice daily)
- 50 kg or more - 12,000 mg twice daily (60 mL twice daily)
If a dose of DAYBUE is missed, the next dose should be taken as scheduled and doses should not be doubled.
An additional dose should not be taken if vomiting occurs after DAYBUE administration and instead, continue with the next scheduled dose.
Patients are advised to discontinue laxatives prior to starting DAYBUE. The DAYBUE dosage is interrupted or reduced if patients develops severe diarrhea, dehydration or significant weight loss.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Trofinetide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
none
Warnings
1. Diarrhea In a clinical study, it was observed 85% of patients treated with DAYBUE experienced diarrhea and in those, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy.
Patients are advised to discontinue any laxatives prior to starting DAYBUE. Healthcare providers are informed and appropriate management with antidiarrheal agents and fluids are initiated if the patients develop diarrhea during the DAYBUE treatment course. Interrupt, reduce dose, or discontinue DAYBUE, if severe diarrhea occurs or if dehydration is suspected.
2. Weight loss In a clinical study, 12% of patients on DAYBUE developed weight loss greater than 7% from the baseline compared to the 4% of the placebo.
Patients are advised to monitor their weight during the treatment course and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Trofinetide Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Trofinetide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Trofinetide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trofinetide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trofinetide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trofinetide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trofinetide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Trofinetide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Trofinetide in geriatric settings.
Gender
There is no FDA guidance on the use of Trofinetide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trofinetide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trofinetide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trofinetide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trofinetide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trofinetide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Trofinetide Administration in the drug label.
Monitoring
There is limited information regarding Trofinetide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Trofinetide and IV administrations.
Overdosage
There is limited information regarding Trofinetide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Trofinetide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Trofinetide Mechanism of Action in the drug label.
Structure
There is limited information regarding Trofinetide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Trofinetide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Trofinetide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Trofinetide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trofinetide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Trofinetide How Supplied in the drug label.
Storage
There is limited information regarding Trofinetide Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Trofinetide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Trofinetide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Trofinetide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Trofinetide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Trofinetide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Trofinetide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.