Daybue

DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

• Recommended dosage is twice daily, morning and evening, according to patient weight. DAYBUE can be given with or without food. (
  2.1 Dosing Information

  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
  )

• Can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. (
  2.2 Administration Information

  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)]

  .
  )
• See Full Prescribing Information for dosage recommendations in patients with renal impairment. (
  2.5 Dosage Recommendations in Patients With Renal Impairment

  No dosage adjustment is recommended for patients with mild renal impairment (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min for adult patients or 60 to 89 mL/min/1.73 m²for pediatric patients). The recommended dosage of DAYBUE for patients with moderate renal impairment (eGFR 30 to 59 mL/min for adult patients or 30 to 59 mL/min/1.73 m²for pediatric patients) is described in

  Table 2

  [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  DAYBUE is not recommended for patients with severe renal impairment (eGFR less than 30 mL/min for adult patients or less than 30 mL/min/1.73 m²for pediatric patients).

  Table 2 Recommended Dosage of DAYBUE in Patients With Moderate Renal Impairment

  Patient Weight	DAYBUE Dosage	DAYBUE Volume
  9 kg to less than 12 kg	2,500 mg twice daily	12.5 mL twice daily
  12 kg to less than 20 kg	3,000 mg twice daily	15 mL twice daily
  20 kg to less than 35 kg	4,000 mg twice daily	20 mL twice daily
  35 kg to less than 50 kg	5,000 mg twice daily	25 mL twice daily
  50 kg or more	6,000 mg twice daily	30 mL twice daily
  ,
  8.6 Renal Impairment

  Mild renal impairment is not expected to impact the exposure of trofinetide; therefore, dosage adjustment is not necessary. Dosage adjustment of DAYBUE is recommended in patients with moderate renal impairment (adult: eGFR 30 to 59 mL/min; pediatric: eGFR 30 to 59 mL/min/1.73 m²)

  [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)]

  . Administration of DAYBUE to patients with severe renal impairment (eGFR less than 30 mL/min for adults or less than 30 mL/min/1.73 m²for pediatrics) is not recommended

  .
  )

Trofinetide oral solution: 200 mg/mL of a pink to red, strawberry flavored solution.

Severe renal impairment: DAYBUE is not recommended. (