Trofinetide

Trofinetide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]

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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

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Package and Label Display Panel

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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.