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.

TALVEY (BLA-761342)

(TALQUETAMAB-TGVS)

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

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10/02/2025 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Neurologic Toxicity including ICANS

Additions and/or revisions underlined:

TALVEY can cause serious, life-threatening, or fatal neurologic toxicity, including ICANS [see Adverse Reactions (6.1)].

In the clinical trial, neurologic toxicity, including ICANS, occurred in 55% of patients who received TALVEY at the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction, including ataxia/cerebellar ataxia (10%).

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

MEDICATION GUIDE

Additions and/or revisions underlined:

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Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY and can also be serious, life- threatening, or lead to death. Signs and symptoms of CRS may include:

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Neurologic problems. Symptoms of neurologic problems with TALVEY may include:

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fast eye movements that you cannot control
problems with walking, or loss of balance or coordination

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Decreased blood cell counts. Decreased blood cell counts are common during treatment with TALVEY and can also be severe. Your healthcare provider will check your blood cell counts during treatment with TALVEY. Tell your healthcare provider if you get any symptoms of infection or unusual bleeding or bruising.

…

The most common side effects of TALVEY include:

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rash
low blood pressure

headache

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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 headache, encephalopathy, sensory neuropathy, difficulty speaking and understanding speech, difficulty with coordination, uncontrolled fast eye movement, motor dysfunction including ataxia/cerebellar ataxia, and symptoms of ICANS including confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity occur. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms, until symptoms resolve [see Dosage and Administration (2.2, 2.5), Warnings and Precautions (5.2)].

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