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.

GANIRELIX ACETATE (NDA-021057)

(GANIRELIX ACETATE)

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

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09/23/2024 (SUPPL-24)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Ganirelix Acetate Injection is contraindicated under the following conditions:

• Known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield (see HOW SUPPLIED).

• Known hypersensitivity to GnRH or any other GnRH analog.

• Known or suspected pregnancy (see PRECAUTIONS).

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

General

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance (see ADVERSE REACTIONS). If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.

The rigid needle shield of this product may contain dry natural rubber/latex which comes into contact with this product and may cause allergic reactions (see CONTRAINDICATIONS and HOW SUPPLIED).

08/14/2023 (SUPPL-14)

Approved Drug Label (PDF)

6 Adverse Reactions

Additions and/or revisions underlined:

…

During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with Ganirelix Acetate, as early as with the first dose (see PRECAUTIONS).

Congenital Anomalies

An observational study in more than 1000 newborns compared the incidence of congenital anomalies in newborns of women administered Ganirelix Acetate to historical controls of a GnRH agonist. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using Ganirelix Acetate was comparable with that reported after a COH treatment cycle using a GnRH agonist.

The incidence of congenital malformations after some Assisted Reproductive Technologies (ART) [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. The causal relationship between these congenital anomalies and Ganirelix Acetate Injection is unknown.

08/14/2023 (SUPPL-17)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED).

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

General

The needle shield of this product contains dry natural rubber/latex which comes into contact with this product and may cause allergic reactions (see CONTRAINDICATIONS and HOW SUPPLIED).

08/14/2023 (SUPPL-19)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED).

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

General

The needle shield of this product contains dry natural rubber/latex which comes into contact with this product and may cause allergic reactions (see CONTRAINDICATIONS and HOW SUPPLIED).