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.

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (NDA-205054)

(LEUPROLIDE ACETATE)

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

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11/14/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Severe Cutaneous Adverse Reactions

Newly added subsection:

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), may occur in patients receiving LEUPROLIDE ACETATE FOR DEPOT SUSPENSION; including cases with visceral involvement and/or requiring skin grafts [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 LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 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 LEUPROLIDE ACETATE FOR DEPOT SUSPENSION.

6 Adverse Reactions

Additions and revisions underlined:

The following is discussed in more detail in other sections of the labeling:

Tumor Flare [see Warnings and Precautions (5.1)]
Metabolic Syndrome [see Warnings and Precautions (5.2)]
Cardiovascular Disease [see Warnings and Precautions (5.3)]
Effect on QT/QTc Interval [see Warnings and Precautions (5.4)]
Convulsions [see Warnings and Precautions (5.5)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)]

6.1 Post-marketing Experience

Newly added information:

Skin reactions – rash, urticaria, photosensitivity, erythema multiforme, bullous dermatitis, exfoliative dermatitis, DRESS, SJS/ TEN, and AGEP

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

PATIENT COUNSELING INFORMATION

Newly added information:

Severe Cutaneous Adverse Reactions

Inform patients that severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which may be life threatening or fatal, may occur during treatment with LEUPROLIDE ACETATE FOR DEPOT SUSPENSION.
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)].

08/08/2024 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Metabolic Syndrome

Subsection title revised

Additions and/or revisions underlined:

The use of GnRH agonists may lead to metabolic changes such as hyperglycemia, diabetes mellitus, and hyperlipidemia. Non-alcoholic fatty liver disease, including cirrhosis, occurred in the post-marketing setting. Hyperglycemia may represent new-onset diabetes mellitus or worsening of glycemic control in patients with pre-existing diabetes. Monitor for changes in serum lipids, blood glucose and/or glycosylated hemoglobin (HbA1c) in patients receiving a GnRH agonist, and manage according to current treatment guidelines.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Metabolic Syndrome [see Warnings and Precautions (5.2)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Mood swings, including depression, have been reported. There have been very rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LEUPROLIDE ACETATE FOR DEPOT SUSPENSION.

Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported.

…

Localized reactions including induration and abscess have been reported at the site of injection.

Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.

…

Immune Disorders: Anaphylaxis

Psychiatric Disorders: Depression

Cardiovascular System - hypotension, myocardial infarction, pulmonary embolism

Respiratory, Thoracic and Mediastinal disorder - Pneumonitis, interstitial lung disease

Hepato-biliary disorder - serious drug-induced liver injury, non-alcoholic fatty liver disease

Blood and Lymphatic System - decreased WBC

Central/Peripheral Nervous System - convulsion, peripheral neuropathy, spinal fracture/paralysis Endocrine System - diabetes mellitus

Musculoskeletal System - tenosynovitis-like symptoms Urogenital System - prostate pain

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Metabolic Syndrome

Advise patients that there is an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non- alcoholic fatty liver disease with LEUPROLIDE ACETATE FOR DEPOT SUSPENSION therapy. Inform patients that periodic monitoring for metabolic changes is required when being treated witLEUPROLIDE ACETATE FOR DEPOT SUSPENSION [see Warnings and Precautions (5.2)].