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

• 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.

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

• 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.

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.

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

• 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

• 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.