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.

ELIGARD KIT (NDA-021343)

(LEUPROLIDE ACETATE)

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

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05/06/2026 (SUPPL-60)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

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

. . .

Psychiatric Disorders- Suicidal ideation and attempt

. . .

02/24/2025 (SUPPL-56)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Severe Cutaneous Adverse Reactions

Newly added subsection:

Severe cutaneous adverse reactions (SCARs), including Steve-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and erythema multiforme, occurred in patients receiving ELIGARD [see Adverse Reactions (6.2)].

Monitor patients for the development of SCARs. Advise patients of the signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy).

If a SCAR is suspected, interrupt ELIGARD until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue ELIGARD

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Skin reactions- Erythema multiforme, SJS/TEN

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Severe Cutaneous Adverse Reactions

Inform patients that severe cutaneous adverse reactions (SCARs), including Stevens- Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which may be life threatening or fatal, may occur during treatment with ELIGARD. Advise patients to contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs [see Warnings and Precautions (5.6)].

…

Continuation of ELIGARD Treatment:

Inform patients that ELIGARD is usually continued, often with additional medication, after the development of non-metastatic and metastatic castration-resistant prostate cancer [see Dosage and Administration (2.1)].

07/20/2023 (SUPPL-47)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Convulsions

Newly added subsection:

Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above. Patients receiving a GnRH agonist who experience convulsion should be managed according to current clinical practice.

6 Adverse Reactions

Newly added information

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

· Tumor Flare [see Warnings and Precautions (5.1)]

· Hyperglycemia and Diabetes [see Warnings and Precautions (5.3)]

· Cardiovascular Disease [see Warnings and Precautions (5.4)]

· Effect on QT/QTc Interval [see Warnings and Precautions (5.5)]

· Convulsions [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of ELIGARD®. 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 casual relationship to drug exposure.

…

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

The majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older. Clinical studies of ELIGARD® did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients.

07/20/2023 (SUPPL-48)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Convulsions

Newly added subsection:

6 Adverse Reactions

Newly added information

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

· Tumor Flare [see Warnings and Precautions (5.1)]

· Hyperglycemia and Diabetes [see Warnings and Precautions (5.3)]

· Cardiovascular Disease [see Warnings and Precautions (5.4)]

· Effect on QT/QTc Interval [see Warnings and Precautions (5.5)]

· Convulsions [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

02/15/2019 (SUPPL-39)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Embryo-Fetal Toxicity

(Newly Added Subsection)

Based on findings in animal studies and mechanism of action, leuprolide acetate may cause fetal harm when administered to a pregnant woman. In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

6 Adverse Reactions

6.2 Postmarketing experience

(Additions and/or revisions are underlined)

Pituitary apoplexy-During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Nervous System-Convulsions

Respiratory System-Interstitial lung disease

8 Use in Specific Populations

8.1 Pregnancy

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

Risk Summary

Based on findings in animal studies and mechanism of action, ELIGARD® may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Expected hormonal changes that occur with ELIGARD® treatment increase the risk for pregnancy loss. In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Animal Data

In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug.

8.2 Lactation

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

The safety and efficacy of ELIGARD® have not been established in females. There is no information regarding the presence of ELIGARD® in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from ELIGARD®, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

8.3 Females and Males of Reproductive Potential

(Newly Added Subsection)

Infertility Males

Based on mechanism of action, ELIGARD® may impair fertility in males of reproductive potential

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

PATIENT COUNSELING INFORMATION

(Extensive changes; please refer to labeling)