These Highlights Do Not Include All The Information Needed To Use Daybue Or Daybue Stix Safely And Effectively. See Full Prescribing Information For Daybue And Daybue Stix.

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.

In Study 1 [see Clinical Studies (14)] and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In Study 1, antidiarrheal medication was used in 51% of patients treated with DAYBUE.

Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected [see Dosage and Administration (2.4)].

In Study 1, vomiting occurred in 29% of patients treated with DAYBUE and in 12% of patients who received placebo [see Adverse Reactions (6.1)].

Patients with Rett syndrome are at risk for aspiration and aspiration pneumonia. Aspiration and aspiration pneumonia have been reported following vomiting in patients being treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Dosage and Administration (2.5)].

DAYBUE oral solution and DAYBUE STIX for oral solution contain the active moiety trofinetide. The chemical name of trofinetide is (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). The molecular formula of trofinetide is C₁₃H₂₁N₃O₆ and its molecular weight is 315.33 g/mol. The chemical structure is shown below.

Trofinetide is a white to off-white solid and is freely soluble in water.

DAYBUE oral solution is pink to red in color and contains 1 g of trofinetide in each 5 mL of solution (200 mg/mL). The oral solution also contains FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose as inactive ingredients.

DAYBUE STIX for oral solution is a white, off-white to pinkish powder to be dissolved in a cold to room temperature water or water-based beverage before administration and contains 5,000 mg, 6,000 mg, or 8,000 mg of trofinetide in each packet. The for oral solution powder contains natural strawberry flavor and sucralose as inactive ingredients.

If a dose of DAYBUE or DAYBUE STIX is missed, the next dose should be taken as scheduled. Doses should not be doubled.

In Study 1, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss.

Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs [see Dosage and Administration (2.4)].

DAYBUE (trofinetide) 200 mg/mL oral solution is a pink to red, strawberry flavored solution supplied in a round high-density polyethylene (HDPE) multi-dose bottle with a child-resistant closure containing 450 mL of oral solution (NDC 63090-660-01).

DAYBUE STIX (trofinetide) for oral solution is a white, off-white to pinkish powder with a strawberry flavor supplied in multi-layer aluminum packets as follows:

The safety and effectiveness of DAYBUE and DAYBUE STIX for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older. The safety and effectiveness of DAYBUE for the treatment of Rett syndrome in pediatric patients 5 years of age and older was established in a randomized, double-blind, placebo-controlled, 12-week study (Study 1), which included 108 pediatric patients age 5 to less than 12 years of age and 47 pediatric patients age 12 to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14)]. Use of DAYBUE or DAYBUE STIX in patients 2 to 4 years of age is supported by evidence from Study 1 and pharmacokinetic and safety data in 13 pediatric patients 2 to 4 years of age treated with DAYBUE for 12 weeks [see Dosage and Administration (2.1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Safety and effectiveness in pediatric patients less than 2 years of age have not been established.

Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients. This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

None.

The following clinically significant adverse reactions are described elsewhere in labeling:

• Diarrhea [see Warnings and Precautions (5.1)]
• Weight Loss [see Warnings and Precautions (5.2)]
• Vomiting [see Warnings and Precautions (5.3)]

• Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use. (7.1)

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 m² for pediatrics) is not recommended.

DAYBUE STIX for oral solution demonstrated comparable bioavailability to DAYBUE oral solution in adult healthy subjects under fasted state.

Trofinetide exhibits linear kinetics with no time- or dose-dependent effect on pharmacokinetic parameters. Systemic exposure to trofinetide was dose-proportional across the studied dose range. Minimal to no accumulation was observed following multiple-dose administration.

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.

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

The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

• Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected. (2.4, 5.1)
• Weight Loss: Weight loss may occur in patients treated with DAYBUE or DAYBUE STIX. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs. (2.4, 5.2)
• Vomiting: Aspiration and aspiration pneumonia have occurred after vomiting in patients treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management. (2.5, 5.3)

• 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)

• Can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. (2.1)
• See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. (2.3)
• See Full Prescribing Information for dosage recommendations in patients with renal impairment. (2.6, 8.6)

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.

The following adverse reactions have been identified during postapproval use of DAYBUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Aspiration and aspiration pneumonia secondary to vomiting [see Warnings and Precautions (5.3)].

Severe renal impairment: DAYBUE and DAYBUE STIX are not recommended. (8.6)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled and uncontrolled trials in patients with Rett syndrome, 260 patients ages 2 to 40 years were treated with DAYBUE, including 109 patients treated for more than 6 months, 69 patients treated for more than 1 year, and 4 patients treated for more than 2 years.

The safety of DAYBUE STIX has been established from an adequate, well-controlled study, and open-label studies of DAYBUE [see Clinical Studies (14)]. Below is a display of the adverse reactions of DAYBUE in these studies.

Advise the caregiver or patient to read the FDA-approved patient labeling (Patient Information).

Table 2 includes the volume of DAYBUE oral solution to administer for the corresponding recommended dosage [see Dosage and Administration (2.1, 2.6)]. 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, teaspoon, or tablespoon 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)].

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).

Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs, if dehydration is suspected, or if significant weight loss occurs [see Warnings and Precautions (5.1, 5.2)].

If vomiting occurs after DAYBUE or DAYBUE STIX administration, an additional dose should not be taken. Instead, continue with the next scheduled dose. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Warnings and Precautions (5.3)].

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 m² for 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 m² for 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 m² for 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.

NDC 63090-660-01

450 mL

Rx only

Daybue™

(trofinetide)

oral solution

200 mg/mL

Recommended Dosage:

See prescribing information.

For oral or G-tube administration only.

NDC 63090-660-01

Daybue™

(trofinetide)

oral solution

200 mg/mL

Recommended Dosage:

See prescribing information.

For oral or G-tube administration only.

450 mL

Rx only

NDC 63090-663-60

Daybue^® Stix

(trofinetide)

for oral solution

5,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-663-01

Daybue^® Stix

(trofinetide)

for oral solution

5,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only

NDC 63090-664-60

Daybue^® Stix

(trofinetide)

for oral solution

6,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-664-01

Daybue^® Stix

(trofinetide)

for oral solution

6,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only

NDC 63090-665-60

Daybue^® Stix

(trofinetide)

for oral solution

8,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-665-01

Daybue^® Stix

(trofinetide)

for oral solution

8,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only

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.

In Study 1 [see Clinical Studies (14)] and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In Study 1, antidiarrheal medication was used in 51% of patients treated with DAYBUE.

Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected [see Dosage and Administration (2.4)].

In Study 1, vomiting occurred in 29% of patients treated with DAYBUE and in 12% of patients who received placebo [see Adverse Reactions (6.1)].

Patients with Rett syndrome are at risk for aspiration and aspiration pneumonia. Aspiration and aspiration pneumonia have been reported following vomiting in patients being treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Dosage and Administration (2.5)].

DAYBUE oral solution and DAYBUE STIX for oral solution contain the active moiety trofinetide. The chemical name of trofinetide is (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). The molecular formula of trofinetide is C₁₃H₂₁N₃O₆ and its molecular weight is 315.33 g/mol. The chemical structure is shown below.

Trofinetide is a white to off-white solid and is freely soluble in water.

DAYBUE oral solution is pink to red in color and contains 1 g of trofinetide in each 5 mL of solution (200 mg/mL). The oral solution also contains FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose as inactive ingredients.

DAYBUE STIX for oral solution is a white, off-white to pinkish powder to be dissolved in a cold to room temperature water or water-based beverage before administration and contains 5,000 mg, 6,000 mg, or 8,000 mg of trofinetide in each packet. The for oral solution powder contains natural strawberry flavor and sucralose as inactive ingredients.

If a dose of DAYBUE or DAYBUE STIX is missed, the next dose should be taken as scheduled. Doses should not be doubled.

In Study 1, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss.

Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs [see Dosage and Administration (2.4)].

DAYBUE (trofinetide) 200 mg/mL oral solution is a pink to red, strawberry flavored solution supplied in a round high-density polyethylene (HDPE) multi-dose bottle with a child-resistant closure containing 450 mL of oral solution (NDC 63090-660-01).

DAYBUE STIX (trofinetide) for oral solution is a white, off-white to pinkish powder with a strawberry flavor supplied in multi-layer aluminum packets as follows:

The safety and effectiveness of DAYBUE and DAYBUE STIX for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older. The safety and effectiveness of DAYBUE for the treatment of Rett syndrome in pediatric patients 5 years of age and older was established in a randomized, double-blind, placebo-controlled, 12-week study (Study 1), which included 108 pediatric patients age 5 to less than 12 years of age and 47 pediatric patients age 12 to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14)]. Use of DAYBUE or DAYBUE STIX in patients 2 to 4 years of age is supported by evidence from Study 1 and pharmacokinetic and safety data in 13 pediatric patients 2 to 4 years of age treated with DAYBUE for 12 weeks [see Dosage and Administration (2.1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Safety and effectiveness in pediatric patients less than 2 years of age have not been established.

Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients. This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

None.

The following clinically significant adverse reactions are described elsewhere in labeling:

• Diarrhea [see Warnings and Precautions (5.1)]
• Weight Loss [see Warnings and Precautions (5.2)]
• Vomiting [see Warnings and Precautions (5.3)]

• Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use. (7.1)

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 m² for pediatrics) is not recommended.

DAYBUE STIX for oral solution demonstrated comparable bioavailability to DAYBUE oral solution in adult healthy subjects under fasted state.

Trofinetide exhibits linear kinetics with no time- or dose-dependent effect on pharmacokinetic parameters. Systemic exposure to trofinetide was dose-proportional across the studied dose range. Minimal to no accumulation was observed following multiple-dose administration.

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.

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

The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

• Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected. (2.4, 5.1)
• Weight Loss: Weight loss may occur in patients treated with DAYBUE or DAYBUE STIX. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs. (2.4, 5.2)
• Vomiting: Aspiration and aspiration pneumonia have occurred after vomiting in patients treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management. (2.5, 5.3)

• 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)

• Can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. (2.1)
• See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. (2.3)
• See Full Prescribing Information for dosage recommendations in patients with renal impairment. (2.6, 8.6)

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.

The following adverse reactions have been identified during postapproval use of DAYBUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Aspiration and aspiration pneumonia secondary to vomiting [see Warnings and Precautions (5.3)].

Severe renal impairment: DAYBUE and DAYBUE STIX are not recommended. (8.6)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled and uncontrolled trials in patients with Rett syndrome, 260 patients ages 2 to 40 years were treated with DAYBUE, including 109 patients treated for more than 6 months, 69 patients treated for more than 1 year, and 4 patients treated for more than 2 years.

The safety of DAYBUE STIX has been established from an adequate, well-controlled study, and open-label studies of DAYBUE [see Clinical Studies (14)]. Below is a display of the adverse reactions of DAYBUE in these studies.

Advise the caregiver or patient to read the FDA-approved patient labeling (Patient Information).

Table 2 includes the volume of DAYBUE oral solution to administer for the corresponding recommended dosage [see Dosage and Administration (2.1, 2.6)]. 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, teaspoon, or tablespoon 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)].

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).

Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs, if dehydration is suspected, or if significant weight loss occurs [see Warnings and Precautions (5.1, 5.2)].

If vomiting occurs after DAYBUE or DAYBUE STIX administration, an additional dose should not be taken. Instead, continue with the next scheduled dose. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Warnings and Precautions (5.3)].

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 m² for 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 m² for 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 m² for 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.

NDC 63090-660-01

450 mL

Rx only

Daybue™

(trofinetide)

oral solution

200 mg/mL

Recommended Dosage:

See prescribing information.

For oral or G-tube administration only.

NDC 63090-660-01

Daybue™

(trofinetide)

oral solution

200 mg/mL

Recommended Dosage:

See prescribing information.

For oral or G-tube administration only.

450 mL

Rx only

NDC 63090-663-60

Daybue^® Stix

(trofinetide)

for oral solution

5,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-663-01

Daybue^® Stix

(trofinetide)

for oral solution

5,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only

NDC 63090-664-60

Daybue^® Stix

(trofinetide)

for oral solution

6,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-664-01

Daybue^® Stix

(trofinetide)

for oral solution

6,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only

NDC 63090-665-60

Daybue^® Stix

(trofinetide)

for oral solution

8,000 mg

per packet

For Oral or G-tube

administration only

60 Packets

Rx Only

NDC 63090-665-01

Daybue^® Stix

(trofinetide)

for oral solution

8,000 mg

For Oral or G-tube administration only

Keep out of reach of children

Rx Only