Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

DAYBUE (NDA-217026)

(TROFINETIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/27/2026 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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 112 patients treated for more than 6 months, 92 patients treated for more than 1 year, and 44 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.

…

Common Adverse Reactions

Adverse reactions that occurred in Study 1 in at least 5% of patients treated with DAYBUE and were at least 2% more frequent than in patients on placebo are presented in Table 5.

…

Pediatric Patients with Rett Syndrome 2 to 4 Years of Age

In an open-label study in pediatric patients 2 to 4 years of age with Rett syndrome (N=15), a total of 13 patients received DAYBUE for at least 12 weeks and 10 patients received DAYBUE for at least 12 months. Adverse reactions in pediatric patients 2 to 4 years of age treated with DAYBUE were similar to those reported in adult and pediatric patients 5 years of age and older with Rett syndrome in Study 1.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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

Advise the caregiver or patient that DAYBUE or DAYBUE STIX may be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. DAYBUE or DAYBUE STIX may be taken with or without food [see Dosage and Administration (2.1)].Instruct the caregiver or patient to obtain a calibrated measuring device, such as an oral syringe or oral dosing cup, from the pharmacy. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device [see Dosage and Administration (2.2, 2.3)].

DAYBUE Oral Solution

Instruct the caregiver or patient to discard any unused DAYBUE oral solution after 14 days from first opening the bottle.

DAYBUE STIX for Oral Solution

Advise the caregiver or patient that 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) prior to administration [see Dosage and Administration (2.3)]. Instruct the caregiver or patient on how much water or water-based beverage is needed to dissolve the contents of DAYBUE STIX packet(s).

Instruct the caregiver or patient to administer the prepared oral solution immediately and not to store for future use. Any prepared oral solution not administered must be discarded.

Instruct patients to not attempt to use partial packets to prepare a dose. Diarrhea

Advise the caregiver or patient that DAYBUE or DAYBUE STIX can cause diarrhea. Instruct the patient to stop taking 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 [see Warnings and Precautions (5.1)].

Weight Loss

Inform the caregiver or patient that DAYBUE or DAYBUE STIX may cause weight loss and to notify their healthcare provider if weight loss occurs [see Warnings and Precautions (5.2)].

Vomiting

Advise the caregiver or patient that DAYBUE or DAYBUE STIX can cause vomiting and if vomiting occurs after DAYBUE or DAYBUE STIX administration, do not take an additional dose, but continue with the next scheduled dose [see Dosage and Administration (2.5)]. Instruct patients to notify their healthcare provider if vomiting does not stop despite medical management [see Warnings and Precautions (5.3)].

Storage

DAYBUE Oral Solution

Keep bottles of DAYBUE upright and refrigerated before and after opening. Do not freeze [see How Supplied/Storage and Handling (16.2)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

How should I take DAYBUE or DAYBUE STIX?

Take DAYBUE or DAYBUE STIX exactly as your healthcare provider tells you to take it.
If you have kidney problems, talk to your healthcare provider about the right dose of DAYBUE or DAYBUE STIX.
If you take laxatives, stop taking them before starting treatment with DAYBUE or DAYBUE STIX.
DAYBUE or DAYBUE STIX may be given by mouth or through a gastrostomy (G) tube. If DAYBUE or DAYBUE STIX is given through a gastrojejunal (GJ) tube, the G-port must be used.
DAYBUE or DAYBUE STIX may be taken with or without food.
Your pharmacist should provide an oral syringe or dosing cup that is needed to measure your prescribed dose of DAYBUE or the amount of liquid to mix with DAYBUE STIX powder. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.
If you are taking DAYBUE oral solution:
- Throw away any unused DAYBUE oral solution after 14 days of first opening the bottle.
If you are taking DAYBUE STIX for oral solution:
- Open each packet only when you are ready to use it.
- DAYBUE STIX powder must be dissolved in cold to room temperature water or water-based beverage (juice, tea, lemonade, or liquid hydration).
- Your healthcare provider will tell you how much cold to room temperature water or water-based beverage to use to dissolve the powder in each packet.
- Empty the entire contents of the DAYBUE STIX packets needed for your prescribed dose into the measured liquid. Do not attempt to use part of a packet.
- Stir until the powder is completely dissolved.
- After the powder is dissolved, take the prepared oral solution right away. Do not store for future use.
- Throw away any prepared oral solution that was not taken.
Your healthcare provider may change your dose or stop treatment with DAYBUE or DAYBUE STIX if needed.

…

How should I store DAYBUE or DAYBUE STIX?

DAYBUE oral solution:
- Store DAYBUE oral solution bottle in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
- Keep DAYBUE oral solution bottle in an upright position.
- Keep the child-resistant cap on the bottle tightly closed.
DAYBUE STIX for oral solution:
- Store DAYBUE STIX for oral solution powder packets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep DAYBUE, DAYBUE STIX, and all medicines out of the reach of children.

…

What are the ingredients in DAYBUE or DAYBUE STIX?

Active ingredient: trofinetide

DAYBUE oral solution inactive ingredients: FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose.

DAYBUE STIX for oral solution inactive ingredients: natural strawberry flavor and sucralose.

08/05/2025 (SUPPL-6)

Approved Drug Label (PDF)

7 Drug Interactions

Additions and/or revisions underlined:

CYP3A and/or P-gp Substrates

Closely monitor patients when DAYBUE is administered concomitantly with sensitive CYP3A and/or P-gp substrates where minimal increases in the plasma concentration of these substrates may lead to serious adverse reactions. Trofinetide, a weak inhibitor of CYP3A and an inhibitor of P-gp, increased the plasma concentrations of CYP3A and/or P-gp substrates [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions associated with these substrates.

09/30/2024 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

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 m2 for pediatrics) is not recommended.

09/30/2024 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Vomiting

Newly added subsection:

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 if vomiting is severe or occurs despite medical management [see Dosage and Administration (2.4)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Vomiting [see Warnings and Precautions (5.3)]

6.2 Postmarketing Experience

Newly added subsection:

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)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Vomiting

Advise the caregiver or patient that DAYBUE can cause vomiting and if vomiting occurs after DAYBUE administration, do not take an additional dose, but continue with the next scheduled dose [see Warnings and Precautions (5.3)]. Instruct patients to notify their healthcare provider if vomiting does not stop despite medical management.

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

How should I take DAYBUE?

Take DAYBUE exactly as your healthcare provider tells you to take it.
If you take laxatives, stop taking them before starting treatment with DAYBUE.
Your healthcare provider may change your dose or stop treatment with DAYBUE if needed.
Your pharmacist should provide an oral syringe or dosing cup that is needed to measure your prescribed dose. Do not use a household measuring cup.
DAYBUE may be taken by mouth or given through a gastrostomy (G) tube. If DAYBUE is given through a gastrojejunal (GJ) tube, the G-port must be used.
DAYBUE may be taken with or without food.
Throw away any unused DAYBUE after 14 days of first opening the bottle.
If you vomit after taking a dose of DAYBUE, do not take another dose to make up for that dose. Wait and take the next dose at your usual time. Call your healthcare provider if your vomiting does not stop.
If you miss a dose of DAYBUE, skip that dose and take your next dose at your usual time. Do not take 2 doses to make up the missed dose.

What are the possible side effects of DAYBUE?

DAYBUE may cause side effects, including:

. . .

Vomiting. Vomiting is a common side effect of DAYBUE. Sometimes vomit can get into your lungs (aspiration), which could cause an infection (aspiration pneumonia). Tell your healthcare provider if you have severe vomiting or if vomiting happens often.

. . .