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.

ZYNLONTA (BLA-761196)

(LONCASTUXIMAB TESIRINE-LPYL)

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

Download Data

Expand all

02/20/2026 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Effusion and Edema, Including Capillary Leak Syndrome

Subsection title revised

Additions and/or revisions underlined:

Serious effusion and edema, including capillary leak syndrome, occurred in patients treated with ZYNLONTA. Grade 3 edema occurred in 3% (primarily peripheral edema or ascites) and Grade 3 pleural effusion occurred in 3%, and Grade 3 or 4 pericardial effusion occurred in 1% [see Adverse Reactions (6.1)]. Rare cases of cardiac tamponade have been reported in patients with Grade 3 or 4 pericardial effusion. Grade 3 or higher capillary leak syndrome occurred in 0.6%.

Monitor patients for new or worsening edema or effusions. Consider diagnostic imaging in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnea, chest pain, and/or ascites such as swelling in the abdomen and bloating. Institute appropriate medical management for edema or effusions.

Evaluate and institute appropriate medical management for capillary leak syndrome in patients experiencing worsening effusion or edema, with signs and symptoms of weight gain, severe hypotension, hypoalbuminemia, and/or hemoconcentration (by elevated hemoglobin/hematocrit, etc.).

Withhold or discontinue ZYNLONTA based on severity [see Dosage and Administration (2.3)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postapproval use of ZYNLONTA. 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.Skin and Subcutaneous Tissue Disorders: Telangiectasia, including cutaneous collagenous vasculopathy, blister, rash vesicular.

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

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

Fluid retention, including capillary leak syndrome (CLS). Fluid retention has happened in people treated with ZYNLONTA, and can be serious and become life-threatening. Too much fluid buildup in your body can cause fluid to leak from blood vessels into the body’s tissues. This condition is called capillary leak syndrome (CLS). Tell your healthcare provider and get emergency help right away if you develop new or worsening signs and symptoms of fluid retention including CLS:
- swelling or puffiness
- feeling unusually weak or tired
- rapid weight gain
- dizziness or feeling faint especially when standing up
- chest pain
- trouble breathing

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Effusion and Edema, Including Capillary Leak Syndrome: Advise patients to contact their healthcare provider if they experience swelling, rapid weight gain, shortness of breath, worsening malaise, dizziness, or difficult, labored breathing. [see Warnings and Precautions (5.1)].

…

01/16/2026 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hepatotoxicity, Including Drug-Induced Liver Injury

Newly added subsection:

Cholestatic and hepatocellular liver injury, including severe, life-threatening, and fatal cases of drug-induced liver injury (DILI), have occurred in patients treated with ZYNLONTA.

Monitor liver function tests at baseline and throughout treatment with ZYNLONTA. In the event of suspected DILI or Grade ?3 increase in ALT or AST, withhold ZYNLONTA until toxicity resolves to Grade 1 or lower. Upon confirmation of DILI, discontinue ZYNLONTA. [see Dosage and Administration (2.3)].

ZYNLONTA should be avoided in patients with severe hepatic impairment [see Clinical Pharmacology (8.6, 12.3)].

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Effusion and Edema [see Warnings and Precautions (5.1)] Myelosuppression [see Warnings and Precautions (5.2)] Infections [see Warnings and Precautions (5.3)] Hepatotoxicity, including DILI [see Warnings and Precautions (5.4)] Cutaneous Reactions [see Warnings and Precautions (5.5)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other Clinical Trials Experience

The following adverse reactions have been reported following administration of ZYNLONTA:

Hepatotoxicity, including drug- induced liver injury (DILI).

8 Use in Specific Populations

8.6 Hepatic Impairment

Additions and/or revisions underlined:

No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin

less than or equal to upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN or total bilirubin > 1 to 1.5 × ULN and any AST). Monitor patients with mild hepatic impairment for potential increased incidence of adverse reactions and modify the ZYNLONTA dosage in the event of adverse reactions [see Dosage and Administration (2.3)].

There is limited safety information available in patients with moderate hepatic impairment. ZYNLONTA should be avoided in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

Liver problems, including Drug-Induced Liver Injury (DILI). Liver problems have happened in people treated with ZYNLONTA, and can be severe or life-threatening, or cause death. Your healthcare provider will do blood tests to monitor your liver function before and during treatment with ZYNLONTA. Tell your healthcare provider if you get stomach-area (abdomen) discomfort, itching of the skin, dark or “tea-colored” urine, or yellowing of your skin or the whites of your eyes (jaundice).
Skin Reactions. Serious skin reactions have happened in people treated with ZYNLONTA. Tell your healthcare provider if you get new or worsening skin reactions,
including sensitivity to sunlight, skin rash, peeling, redness or irritation. You may burn more easily or get severe sunburns. See “What should I avoid while receiving ZYNLONTA?”
Your healthcare provider may temporarily stop your treatment, lower your dose or permanently stop treatment with ZYNLONTA if you have certain severe side effects.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Infections: Advise patients to immediately contact their healthcare provider for signs or symptoms of infection, including fever, chills, weakness and/or difficulty breathing [see Warnings and Precautions (5.3)].
Hepatotoxicity, Including Drug-Induced Liver Injury: Inform patients that liver problems, including drug-induced liver injury and abnormalities in liver tests, may develop during ZYNLONTA treatment. Advise patients that they will need monitoring of their liver through regular blood testing throughout their treatment. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, pruritus, dark urine, or jaundice. [see Warnings and Precautions (5.4)].

…

10/12/2022 (SUPPL-4)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and revisions underlined:

. . .

Advise women of reproductive potential to use effective contraception during treatment and for 10 months after the last dose.

. . .

Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during the treatment with ZYNLONTA and for 7 months after the last dose [see Nonclinical Toxicology (13.1)].

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

Patient Information

Additions and revisions underlined:

Females who can become pregnant:

Your healthcare provider may do a pregnancy test before starting treatment with ZYNLONTA.
You should use effective birth control (contraception) during treatment with ZYNLONTA and for 10 months after the last dose of ZYNLONTA. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZYNLONTA.
Males with female partners who can become pregnant:
You should use effective birth control (contraception) during treatment with ZYNLONTA and for 7 months after the last dose of ZYNLONTA.

10/12/2022 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:

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

Skin and Subcutaneous Tissue Disorders: telangiectasia, blister, rash vesicular