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.

SYNAGIS (BLA-103770)

(PALIVIZUMAB)

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

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05/12/2017 (SUPPL-5200)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)

Risk Summary

Synagis is not indicated for use in females of reproductive potential.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)

Risk Summary

Synagis is not indicated for use in females of reproductive potential.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient’s caregiver to read the FDA-approved patient labeling (Patient Information)

Hypersensitivity Reactions

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 severe hypersensitivity reaction to Synagis.

Administration

Advise the patient’s caregiver that Synagis should be administered by a healthcare provider once a month during the RSV season by intramuscular injection and the importance of compliance with the full course of therapy.

PATIENT INFORMATION

(Additions and/or revisions are underlined)

What is SYNAGIS?

SYNAGIS is a prescription medication that is used to help prevent a serious lung disease caused by

Respiratory Syncytial Virus (RSV) in children:

born prematurely (at or before 35 weeks) and who are 6 months of age or less at the beginning of RSV season,
who have a chronic lung condition called bronchopulmonary dysplasia (BPD), that needed medical treatment within the last 6 months, and who are 24 months of age or less at the beginning of RSV season,
born with certain types of heart disease and who are 24 months of age or less at the beginning of RSV season.

SYNAGIS contains man-made, disease-fighting proteins called antibodies.

It is not known if SYNAGIS is safe and effective to treat the symptoms of RSV in a child who already has

RSV. Synagis is used to help prevent RSV disease.

It is not known if SYNAGIS is safe and effective in children who are older than 24 months of age at the start of dosing.

How is SYNAGIS given?

Your child’s healthcare provider will give you detailed instructions on when SYNAGIS will be given.

“RSV season” is the time of year when RSV infections most commonly happen, usually fall through spring, but it may begin earlier or last longer in certain areas)…
Your child should receive the first SYNAGIS injection before the RSV season starts to help prevent RSV infection…

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

Severe allergic reactions. Severe allergic reactions may happen after any injection of SYNAGIS, and may be life-threatening or cause death. Call your healthcare provider or get medical help right away if your child has any of the signs or symptoms of a serious allergic reaction.