Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

ROZLYTREK (NDA-218550)

(ENTRECTINIB)

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

Download Data

Expand all

10/01/2026 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Ventricular Arrhythmias

Subsection title revised

Additions and/or revisions underlined:

Among the 355 patients who received ROZLYTREK across the clinical trials, 3.1% of patients with at least one post-baseline ECG assessment experienced QTc interval prolongation of > 60 ms after starting ROZLYTREK and 0.6% had a QTc interval > 500 ms.

Monitor patients who have or are at significant risk of developing QTc interval prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QTc prolongation. Assess QTc interval and electrolytes prior to initiation of ROZLYTREK and periodically during treatment, adjusting frequency based upon risk factors such as congestive heart failure, electrolyte abnormalities, or concomitant medications known to prolong the QTc interval.

Brugada pattern, Brugada syndrome, and ventricular tachycardia have been reported in the postmarketing setting in patients who received ROZLYTREK [see Adverse Reactions (6.2)]. Monitor patients who have or are at significant risk of developing QRS prolongation, including patients with known Brugada syndrome, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QRS prolongation [see Drug Interactions (7.2), Clinical Pharmacology (12.2)].

Based on the severity of QRS or QTc interval prolongation, withhold ROZLYTREK and then resume at same or reduced dose, or permanently discontinue [see Dosage and Administration (2.7)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Ventricular Arrhythmias [see Warnings and Precautions (5.2)]

6.2 Postmarketing Experience

Newly added information:

The following adverse reactions have been identified during post-approval use of ROZLYTREK. 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.

Cardiac Disorders: Brugada pattern and Brugada syndrome, including documented monomorphic ventricular tachycardia.

7 Drug Interactions

7.3 Drugs That Prolong QRS or QTc Interval

Subsection title revised

Additions and/or revisions underlined:

QRS prolongation, including Brugada pattern or syndrome, and QTc interval prolongation can occur with ROZLYTREK. Avoid coadministration of ROZLYTREK with other products that can prolong the QRS or QTc interval [see Warnings and Precautions (5.2), Clinical Pharmacology (12.2)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Ventricular Arrhythmias

Inform patients of the risks of QRS or QTc interval prolongation and Brugada syndrome, and advise them to report a history of Brugada syndrome, clinically significant arrhythmias, or heart failure and to contact their healthcare provider immediately for severe dizziness, syncope or palpitations [see Warnings and Precautions (5.2)].

PATIENT INFORMATION

Additions and/or revisions underlined:

What is the most important information I should know about ROZLYTREK?

ROZLYTREK may cause serious side effects, including:

Congestive heart failure. ROZLYTREK may cause congestive heart failure or make the congestive heart failure that you already have worse. Your healthcare provider will do tests before your treatment and may do tests during your treatment with ROZLYTREK to check your heart function.

…

Changes in the electrical activity of your heart called QRS or QTc prolongation. QRS or QTc prolongation can cause irregular heartbeats (arrhythmias) that can be life-threatening. Your healthcare provider will do tests before and during your treatment with ROZLYTREK to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you get severe dizziness, lightheadedness, feel faint, or feel your heart beating irregularly or fast during your treatment with ROZLYTREK. These may be symptoms related to arrhythmias.

…

Increased uric acid level in your blood (hyperuricemia). ROZLYTREK may cause too much uric acid in your blood. Your healthcare provider will do tests before and during your treatment with ROZLYTREK to check the uric acid level in your blood.

…

Before taking ROZLYTREK, tell your healthcare provider about all your medical conditions, including if you:

have heart problems, including a history of heart failure, Brugada pattern or syndrome, or QRS or QTc prolongation.