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.

COLUMVI (BLA-761309)

(GLOFITAMAB-GXBM)

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

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06/22/2026 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Serious Infections

Additions and/or revisions underlined:

…

COLUMVI can cause progressive multifocal leukoencephalopathy (PML), including fatal cases [see Adverse Reactions (6.1)].

COLUMVI should not be administered to patients with an active infection. Administer antimicrobial prophylaxis according to guidelines. Monitor patients before and during COLUMVI treatment for infection, including for neurologic signs and symptoms of PML, and treat appropriately. Withhold or consider permanent discontinuation of COLUMVI 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 other clinical trials:

Immune system disorders: Hemophagocytic Lymphohistiocytosis

Infections: Progressive Multifocal Leukoencephalopathy

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Serious Infections

Advise patients that COLUMVI can cause serious infections. Advise patients to notify their healthcare provider immediately if they develop any signs of infection (e.g., fever, chills, weakness), including signs and symptoms of PML [see Warnings and Precautions (5.3)].

MEDICATION GUIDE

Extensive changes; please refer to label for complete information

05/28/2026 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Cytokine Release Syndrome

Additions and/or revisions underlined:

…

If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis.

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added information:

…

Clinically relevant adverse reactions occurring in other clinical trials:

Immune system disorders: Hemophagocytic Lymphohistiocytosis

10/27/2025 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Clinically relevant adverse reactions occurring in < 10% of patients who received COLUMVI included infusion-related reaction, peripheral neuropathy, pneumonia, mental status changes, vomiting, tumor lysis syndrome, febrile neutropenia, upper respiratory tract infection, sepsis, herpes zoster infection, gastrointestinal hemorrhage, tremor, myelitis, and colitis.

…