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.

BEYFORTUS (BLA-761328)

(NIRSEVIMAB-ALIP)

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

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10/20/2025 (SUPPL-12)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Term and Preterm Infants Entering Their First RSV Season (Trial 09)

The safety of BEYFORTUS was evaluated in Trial 09, a randomized open-label multicenter trial in 8,034 term and preterm infants (GA greater than or equal to 29 weeks) entering their first RSV season (not eligible for palivizumab), who received BEYFORTUS (N=4,016) or no intervention (N=4,018) for the prevention of RSV LRTI hospitalization. Subjects were followed for 365 days post-dose (BEYFORTUS arm) or post-randomization (no intervention arm) to assess safety. The safety profile of BEYFORTUS administered in the first RSV season was consistent with the safety profile of BEYFORTUS in the placebo-controlled Trials 03 and 04.

. . .

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

Trial 09 is a Phase 3b randomized, open-label trial of BEYFORTUS compared to no intervention for the prevention of hospitalization in term and preterm infants (GA greater than or equal to 29 weeks) born during or entering their first RSV season [see Adverse Reactions (6.1) and Clinical Studies (14.5)].

. . .

08/22/2024 (SUPPL-5)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Newly added information:

Use of BEYFORTUS in this population is supported by the following:

Trial 03, a randomized, double-blind, placebo-controlled multicenter trial for the prevention of MA RSV LRTI conducted in preterm infants born at GA greater than or equal to 29 weeks and less than 35 weeks entering their first RSV season;
Trial 04, a double-blind, placebo-controlled multicenter trial, for the prevention of MA RSV LRTI in term and late preterm infants GA greater than or equal to 35 weeks entering their first RSV season;
Trial 05, a Phase 2/3 randomized, double-blind, palivizumab-controlled multicenter trial in pediatric subjects born less than 35 weeks GA and infants with CLD of prematurity or hemodynamically significant CHD entering their first or second RSV season.

In addition, BEYFORTUS was evaluated in an open-label, uncontrolled, single-dose trial (Trial 08) in 100 infants and children who were less than or equal to 24 months of age, who received BEYFORTUS in their first or second RSV season, and who had a wide variety of underlying diseases or treatments resulting in immune compromise. The safety profile of BEYFORTUS administered in Trial 08 was consistent with the safety profile of other trials of BEYFORTUS in infants and children [see Clinical Pharmacology (12.3)].

02/23/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity Reactions Including Anaphylaxis

(Additions and/or revisions underlined)

Serious hypersensitivity reactions have been reported following BEYFORTUS administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.

6 Adverse Reactions

6.2 Postmarketing Experience

(Newly added subsection)

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

Hypersensitivity reactions [see Warnings and Precautions (5.1)].

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise the child’s caregiver to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Including Anaphylaxis

Inform the patient’s caregiver of the signs and symptoms of potential hypersensitivity reactions, and advise the caregiver to seek medical attention immediately if the child experiences a hypersensitivity reaction to BEYFORTUS [see Warnings and Precautions (5.1)].

Dosage and Administration

Advise the caregiver that the child will receive one dose of BEYFORTUS by IM injection by a healthcare provider. If the child remains at increased risk for RSV, they may receive a second dose in the second RSV season [see Dosage and Administration (2.1)].