Source: FDA, National Drug Code (US) Revision Year: 2023
DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
Administer DAYBUE orally twice daily, in the morning and evening, according to patient weight as shown in Table 1. DAYBUE can be taken with or without food.
Table 1. Recommended Dosage of DAYBUE in Patients 2 Years of Age and Older:
| Patient Weight | DAYBUE Dosage | DAYBUE Volume |
|---|---|---|
| 9 kg to less than 12 kg | 5,000 mg twice daily | 25 mL twice daily |
| 12 kg to less than 20 kg | 6,000 mg twice daily | 30 mL twice daily |
| 20 kg to less than 35 kg | 8,000 mg twice daily | 40 mL twice daily |
| 35 kg to less than 50 kg | 10,000 mg twice daily | 50 mL twice daily |
| 50 kg or more | 12,000 mg twice daily | 60 mL twice daily |
Administer DAYBUE orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.
A calibrated measuring device, such as an oral syringe or oral dosing cup, should be obtained from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup is not an adequate measuring device.
Discard any unused DAYBUE oral solution after 14 days of first opening the bottle [see How Supplied/Storage and Handling (16.2)].
If a dose of DAYBUE is missed, the next dose should be taken as scheduled. Doses should not be doubled.
If vomiting occurs after DAYBUE administration, an additional dose should not be taken. Instead, continue with the next scheduled dose.
Advise patients to stop laxatives before starting DAYBUE. Interrupt, reduce the dosage, or discontinue DAYBUE if severe diarrhea occurs, if dehydration is suspected, or if significant weight loss occurs [see Warnings and Precautions (5.1, 5.2)].
Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
Keep the child-resistant cap tightly closed.
Discard any unused DAYBUE oral solution after 14 days of first opening the bottle.
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