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.

LUNSUMIO (BLA-761263)

(MOSUNETUZUMAB-AXGB)

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

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06/18/2026 (SUPPL-10)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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Clinically relevant adverse reactions in < 10% of patients who received LUNSUMIO included pneumonia, sepsis, COVID-19, EBV viremia, mental status changes, tumor lysis syndrome, renal insufficiency, anxiety, motor dysfunction (including ataxia, gait disturbance and tremor), tumor flare, ICANS, and Pneumocystis jirovecii pneumonia.

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11/22/2024 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome

Subsection title revised

Additions and/or revisions underlined:

LUNSUMIO can cause serious and life-threatening neurologic toxicity, including immune effector cell- associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1)].

Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the recommended dose in the clinical trial, with Grade 3 neurologic toxicity occurring in 3% of patients. The most frequent neurologic toxicities were headache (21%), peripheral neuropathy (13%), dizziness (11%), and mental status changes (6%, including confusional state, disturbance in attention, cognitive disorder, delirium, encephalopathy, and somnolence). ICANS was reported in 1% of patients (Grade 1: 0.5%, Grade 2: 0.5%) who received LUNSUMIO at the recommended dose in the clinical trial.]

Across a broader clinical trial population, ICANS or suspected ICANS occurred in 2.1% (20/949) of patients who received LUNSUMIO. The most frequent manifestations included confusional state and lethargy. Nineteen patients had Grade 1-2 events and 1 patient had a Grade 3 event. The majority of cases (75%) occurred during the first cycle of treatment. The median time to onset was 17 days (range: 1 to 48 days). In total, 87% of cases resolved after a median duration of 3 days (range: 1-20 days).

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5.4 Hemophagocytic Lymphohistiocytosis

Newly added subsection:

LUNSUMIO can cause fatal or serious hemophagocytic lymphohistiocytosis (HLH). HLH is a potentially life- threatening, hyperinflammatory syndrome that is independent of CRS. Common manifestations include fever, elevated ferritin, hemophagocytosis, cytopenias, coagulopathy, hepatitis, and splenomegaly.

Across a broader clinical trial population, HLH occurred in 0.5% (7/1536) of patients. Most cases (5/7) were identified within the first 28 days following initiation of LUNSUMIO, with 3 cases preceded by diagnosed or suspected CRS. Of the 7 cases of HLH, 6 had fatal outcomes, with 2 deaths from HLH alone and 4 deaths with concurrent unresolved HLH. Of the 7 cases of HLH, 4 occurred in the context of concurrent EBV and/or CMV infection.

Monitor for clinical signs and symptoms of HLH. Consider HLH when the presentation of CRS is atypical or prolonged, or when there are features of macrophage activation. For suspected HLH, interrupt LUNSUMIO and evaluate and treat promptly for HLH per current practice guidelines.

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions are described elsewhere in the labeling:

Cytokine Release Syndrome [see Warnings and Precautions (5.1)]
Neurologic Toxicity, including Immune Effector Cell-associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2)]
Infections [see Warnings and Precautions (5.3)]
Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.4)]
Cytopenias [see Warnings and Precautions (5.5)]
Tumor Flare [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

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

MEDICATION GUIDE

Additions and/or revisions underlined:

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Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including if you:

…

are pregnant or plan to become pregnant. LUNSUMIO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO.
Females who are able to become pregnant:
- your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO.
- you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO.

…

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

See “What is the most important information I should know about LUNSUMIO?”

neurologic problems. LUNSUMIO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO, including:
- headache
- sleepiness or trouble sleeping
- numbness and tingling of the arms, legs, hands, or feet
- tremors
- dizziness
- loss of consciousness
- confusion and disorientation
- seizures
- difficulty paying attention or understanding things
- muscle problems or muscle weakness
- forgetting things or forgetting who or where you are
- loss of balance or trouble walking
- trouble speaking, reading, or writing
- tiredness

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hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis (HLH). HLH can be life-threatening and has led to death in people treated with LUNSUMIO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
- fever
- low blood cell counts
- enlarged spleen
- liver problems
- easy bruising
low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be serious or severe.
Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO can cause the following low blood cell counts:

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growth in your tumor or worsening of tumor related problems (tumor flare). LUNSUMIO can cause serious or severe worsening of your tumor.

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The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

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PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Neurologic Toxicity, including ICANS – Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, headache, peripheral neuropathy, dizziness, or mental status changes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients who experience neurologic toxicity that impairs consciousness to refrain from driving or operating heavy or potentially dangerous machinery until neurologic toxicity resolves [see Warnings and Precautions (5.2)].

Infections – Discuss the signs or symptoms associated with infection [see Warnings and Precautions (5.3)].

Hemophagocytic Lymphohistiocytosis (HLH) – Discuss the signs and symptoms associated with HLH, including fever, coagulopathy, cytopenias, and splenomegaly [see Warnings and Precautions (5.4)].

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