Daybue (Trofinetide)

DAYBUE and DAYBUE STIX are 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 or DAYBUE STIX can be given with or without food. (
  2.1 Recommended Dosage

  The recommended dosage of DAYBUE or DAYBUE STIX is based on patient weight as shown in

  Table 1

  . Administer DAYBUE or DAYBUE STIX orally or via gastrostomy (G) tube twice daily, in the morning and evening, with or without food. Doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.

  Table 1 Recommended Dosage of DAYBUE or DAYBUE STIX in Patients 2 Years of Age and Older

  Patient Weight	Recommended Dosage
  9 kg to less than 12 kg	5,000 mg twice daily
  12 kg to less than 20 kg	6,000 mg twice daily
  20 kg to less than 35 kg	8,000 mg twice daily
  35 kg to less than 50 kg	10,000 mg twice daily
  50 kg or more	12,000 mg twice daily
  )

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

  The recommended dosage of DAYBUE or DAYBUE STIX is based on patient weight as shown in

  Table 1

  . Administer DAYBUE or DAYBUE STIX orally or via gastrostomy (G) tube twice daily, in the morning and evening, with or without food. Doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.

  Table 1 Recommended Dosage of DAYBUE or DAYBUE STIX in Patients 2 Years of Age and Older

  Patient Weight	Recommended Dosage
  9 kg to less than 12 kg	5,000 mg twice daily
  12 kg to less than 20 kg	6,000 mg twice daily
  20 kg to less than 35 kg	8,000 mg twice daily
  35 kg to less than 50 kg	10,000 mg twice daily
  50 kg or more	12,000 mg twice daily
  )
• See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. (
  2.3 DAYBUE STIX for Oral Solution Preparation

  Prior to administration, DAYBUE STIX for oral solution powder must be dissolved in a cold to room temperature water or water-based beverage (juice, tea, lemonade, limeade, or liquid hydration).

  Preparation of DAYBUE STIX

  • Determine the correct dosage as shown in

    Table 1

    or

    Table 4

    (for patients with moderate renal impairment).
  • Select the appropriate packet strength and number of packets required for each dose, as shown in

    Table 3

    .
  • Determine the appropriate volume of liquid within the recommended volume range as shown in

    Table 3

    , based on individual patient factors (e.g., age, palatability).
  • Measure the volume of liquid determined in Step 3 by using a calibrated measuring device obtained from the pharmacy.
  • Empty the entire contents of the DAYBUE STIX packet(s) into the measured liquid. Do not attempt to use partial packets to prepare a dose.
  • Stir until the powder is completely dissolved.
  • Administer the prepared oral solution immediately; do not store for future use.
  • Discard any prepared oral solution that is not immediately administered.

  Table 3 Preparation Instructions for DAYBUE STIX for Oral Solution Powder

  Dose	DAYBUE STIX Packet(s) Needed to Prepare Each Dose	Volume of Liquid Required to Dissolve Entire Dose Liquid types include water or water-based beverage. , Volume should be selected within the recommended range based on individual patient factors.
  5,000 mg	One 5,000 mg packet	15 mL to 60 mL
  6,000 mg	One 6,000 mg packet	15 mL to 60 mL
  8,000 mg	One 8,000 mg packet	25 mL to 120 mL
  10,000 mg	Two 5,000 mg packets	30 mL to 120 mL (each packet requires 15 mL to 60 mL)
  12,000 mg	Two 6,000 mg packets	30 mL to 120 mL (each packet requires 15 mL to 60 mL)
  )
• See Full Prescribing Information for dosage recommendations in patients with renal impairment. (
  2.6 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 or DAYBUE STIX 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 4

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

  DAYBUE and DAYBUE STIX are 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).

  For patients with moderate renal impairment who require a dose less than 5,000 mg, DAYBUE oral solution is recommended. Do not attempt to use partial packets of DAYBUE STIX to prepare a dose.

  Table 4 Recommended Dosage of DAYBUE or DAYBUE STIX in Patients with Moderate Renal Impairment

  Patient Weight	Recommended Dosage
  9 kg to less than 12 kg	2,500 mg twice daily Use DAYBUE oral solution to administer this dosage.
  12 kg to less than 20 kg	3,000 mg twice daily
  20 kg to less than 35 kg	4,000 mg twice daily
  35 kg to less than 50 kg	5,000 mg twice daily
  50 kg or more	6,000 mg 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 or DAYBUE STIX 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 (2.6), Clinical Pharmacology (12.3)]

  . Administration of DAYBUE or DAYBUE STIX 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

  .
  )

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

For oral solution: 5,000 mg, 6,000 mg, or 8,000 mg of white, off-white to pinkish powder with strawberry flavor, packaged in individual packets.

Severe renal impairment: DAYBUE and DAYBUE STIX are not recommended. (