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.

DANYELZA (BLA-761171)

(NAXITAMAB-GQGK)

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

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03/20/2024 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Infusion-Related Reactions

Additions and/or revisions underlined:

…

Caution is advised in patients with pre-existing cardiac disease, as this may exacerbate the risk of severe hypotension.

5.3 Myocarditis

Newly added subsection:

Myocarditis has occurred in adolescent patients receiving DANYELZA in clinical trials and expanded access programs. Myocarditis occurred within days of receiving DANYELZA requiring drug interruption.

Monitor for signs and symptoms of myocarditis during treatment with DANYELZA. Withhold, reduce the dose, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

5.5 Orthostatic Hypotension

Newly added subsection:

Orthostatic hypotension has occurred in patients receiving DANYELZA in clinical trials and expanded access programs. Severe orthostatic hypotension, including cases requiring hospitalization, have occurred. Cases occurred within hours to 6 days of DANYELZA infusions in any cycle.

In patients with symptoms of orthostatic hypotension, monitor postural blood pressure prior to initiating treatment with DANYELZA and as clinically indicated with subsequent dosing. Withhold, reduce dose, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.3)].

5.6 Embryo-Fetal Toxicity

Additions and/or revisions underlined:

Based on its mechanism of action, DANYELZA may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential, including pregnant women, of the potential risk to a fetus. Advise females of reproductive potential to use effective contraceptive during treatment with DANYELZA and for two months after the last dose. [see Use in Specific Populations (8.1, 8.3)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Myocarditis [see Warnings and Precautions (5.3)]
Orthostatic Hypotension [see Warnings and Precautions (5.5)]

6.3 Postmarketing Experience/Spontaneous Reports

Additions and/or revisions underlined:

The following adverse reactions have been identified during expanded access and post-approval use of DANYELZA. 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.

Neurological: Orthostatic hypotension, Transverse myelitis

Cardiac disorders: Myocarditis

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of naxitamab-gqgk in human milk or its effects on the breastfed child, or on milk production, however, human IgG is present in human milk. Because of the potential for serious adverse reactions in a breastfed child from DANYELZA, advise women not to breastfeed during treatment and for 2 months after the last dose of DANYELZA.

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

…

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of DANYELZA.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Myocarditis

Advise patients and caregivers that myocarditis has been seen in patients taking DANYELZA and to report any signs or symptoms, such as chest pain, shortness of breath or abnormal heart rhythms during treatment with DANYELZA [see Warnings and Precautions (5.3)].

…

Orthostatic Hypotension

Advise patients and caregivers that DANYELZA can cause severe low blood pressure when standing after sitting or lying down. Advise patients and caregivers to report any signs or symptoms, such as dizziness, lightheadedness or fainting during treatment with DANYELZA [see Warnings and Precautions (5.5)].

…

Lactation

Advise women not to breastfeed during treatment with DANYELZA and for 2 months after the last dose [see Use in Specific Populations (8.2)].

PATIENT INFORMATION

Additions and/or revisions underlined:

What is DANYELZA?

…

It is not known if DANYELZA is safe and effective in children younger than 1 year of age.

…

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

…

have heart disease

…

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

…

Swelling of the heart (myocarditis). Myocarditis has happened in adolescents ages 12 to 18 within days of receiving DANYELZA. Tell your healthcare provider if you get any signs or symptoms of myocarditis, including:

chest pain
irregular heartbeat or feel like your heart is racing
shortness of breath

…

Decreased blood pressure (orthostatic hypotension) that can be severe and require hospitalization. You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position. Your healthcare provider will monitor your blood pressure before you start and during treatment with DANYELZA.