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.

LAZCLUZE (NDA-219008)

(LAZERTINIB MESYLATE)

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

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04/30/2026 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hepatotoxicity

Newly added subsection:

LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST). In MARIPOSA [see Adverse Reactions (6.1)], based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%.

LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.

Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

. . .

Hepatotoxicity [see Warnings and Precautions (5.4)]

. . .

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Hepatotoxicity

Advise patients of the risks of hepatotoxicity, and that they will need to undergo liver function tests before and during treatment. Advise patients to immediately contact their healthcare provider if they develop signs or symptoms of hepatotoxicity [see Warnings and Precautions (5.4)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

What are the possible side effects of LAZCLUZE? LAZCLUZE may cause serious side effects, including:

. . .

liver problems. LAZCLUZE may cause severe liver problems, including increased liver function tests. Your healthcare provider will do blood tests to check your liver before you start and during treatment with LAZCLUZE. Tell your healthcare provider right away if you get any symptoms of liver problems, including pain on the right side of your stomach area (abdomen), dark or brown (tea colored) urine, or yellowing of your skin or the white part of your eyes.

. . .

11/07/2025 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Dermatologic Adverse Reactions

Additions and/or revisions underlined:

LAZCLUZE in combination with amivantamab can cause severe rash including dermatitis acneiform, pruritus and dry skin.

In MARIPOSA [see Adverse Reactions (6.1)], rash occurred in 86% of patients treated with LAZCLUZE in combination with amivantamab, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose reduction of LAZCLUZE occurred in 19% of patients, rash leading to dose interruption of LAZCLUZE occurred in 30% of patients, and LAZCLUZE was permanently discontinued due to rash in 1.7% of patients [see Adverse Reactions (6.1)].

When initiating treatment with LAZCLUZE in combination with amivantamab, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions [see Dosage and Administration (2.3)]. Instruct patients to limit sun exposure during and for 2 months after treatment with LAZCLUZE in combination with amivantamab. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, administer oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, reduce the dose or permanently discontinue LAZCLUZE and amivantamab based on severity [see Dosage and Administration (2.4)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Clinically relevant adverse reactions occurring in < 10% of patients who received LAZCLUZE in combination with amivantamab included skin ulcer (applicable to amivantamab) and ILD/pneumonitis.

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Dermatologic Adverse Reactions

Advise patients of the risk of dermatologic adverse reactions. Advise patients that prophylactic oral antibiotics are recommended starting on Day 1 for the first 12 weeks of treatment and, after completion of oral antibiotic treatment, topical antibiotic lotion to the scalp for the next 9 months of treatment. Advise patients to use non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying components) on the face and whole body (except scalp) and 4% chlorhexidine solution to wash hands and feet, while on treatment. Advise patients to limit direct sun exposure during and for 2 months after treatment, to wear protective clothing, and to use broad-spectrum UVA/UVB sunscreen to reduce the risk and severity of dermatologic adverse reactions [see Warnings and Precautions (5.3)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

How should I take LAZCLUZE?

…

Your healthcare provider may give you medicines in addition to LAZCLUZE to reduce the risk and severity of skin and nail reactions.

…

What should I avoid while taking LAZCLUZE?

LAZCLUZE can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with LAZCLUZE. Wear protective clothing and use broad-spectrum UVA/UVB sunscreen during treatment with LAZCLUZE.

…

What are the possible side effects of LAZCLUZE? LAZCLUZE may cause serious side effects, including:

blood clot problems. Blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) are serious, but common, and may lead to death. Your healthcare provider will start you on medicine to reduce the risk of blood clots for the first four months of treatment. Tell your healthcare provider right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.

…

skin problems. LAZCLUZE may cause severe rash including redness, raised acne-like bumps, itching, and dry skin. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may start you on an antibiotic for the first 3 months of treatment followed by an antibiotic lotion for your scalp for the next 9 months. During treatment with LAZCLUZE, you should apply a non-comedogenic (does not clog pores) skin moisturizer (ceramide-based or other types of moisturizers that provide long-lasting skin hydration and does not include drying ingredients) on your face and whole body (except scalp) and wash your hands and feet every day with 4% chlorhexidine solution. Your healthcare provider may treat you with a medicine(s) or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with LAZCLUZE. See “What should I avoid while taking LAZCLUZE?”

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