Trofinetide Dosage

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

Applies to the following strengths: 200 mg/mL

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 day

Comments:

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 day

Comments:

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

Renal Dose Adjustments

Mild renal dysfunction: Data not available
Moderate to Severe renal dysfunction: Use is not recommended.

Liver Dose Adjustments

Data not available

Dose Adjustments

Diarrhea or Weight Loss:

Advise patients to withhold laxatives prior to starting treatment with this drug.
Interrupt, reduce the dosage, or discontinue the therapy:
if severe diarrhea occurs.
if dehydration is suspected.
if significant weight loss occurs.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

This drug can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.

Storage requirements:

Store in an upright position, refrigerated between 2C to 8C (36F to 46F).
Do not freeze.
Keep the child-resistant cap tightly closed.

Monitoring:
Renal: Renal function

Patient advice:

Read the US FDA-approved patient labeling (Patient Information).
This drug can be taken with or without food.
Obtain a calibrated measuring device to measure and deliver the prescribed dose accurately.
If you take laxatives, stop taking them before starting treatment with this drug.
Inform healthcare provider if you have kidney problems, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed prior to

initiating therapy with this drug.

Discard unused solution after 14 days of first opening the bottle.
This drug may cause weight loss, notify healthcare provider if weight loss occurs.
In the event of vomiting, do not take another dose to make up for that dose. Wait and take the following dose as scheduled.
This drug may cause diarrhea; if this occurs notify healthcare provider and consider starting antidiarrheal treatment.
Monitor hydration status and increase oral fluids, if needed.