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.

CAMCEVI ETM (NDA-219745)

(LEUPROLIDE MESYLATE)

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

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07/21/2026 (SUPPL-1)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:
CAMCEVI ETM and CAMCEVI are contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs, or any of the excipients in CAMCEVI ETM or CAMCEVI. Anaphylactic reactions to GnRH agonist analogs have been reported in medical literature.

5 Warnings and Precautions

5.1 Tumor Flare

Additions and/or revisions underlined:

CAMCEVI ETM and CAMCEVI, like other GnRH agonists, cause a transient increase in serum levels of testosterone during the first week of treatment, declining thereafter to baseline levels or below by the end of the second week of treatment. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostate cancer, may develop during the first few weeks of CAMCEVI ETM or CAMCEVI treatment. Patients treated with CAMCEVI ETM or CAMCEVI may experience a temporary increase in bone pain, which can be managed symptomatically.

…

5.3 Cardiovascular Diseases

Additions and/or revisions underlined:

Increased risk of developing myocardial infarction, sudden cardiac death, and stroke has been reported in association with use of GnRH agonists in men. Evaluate patients for cardiovascular risk factors.

Monitor for symptoms and signs suggestive of development of cardiovascular disease and manage according to current clinical practice.

5.5 Convulsions

Additions and/or revisions underlined:

Convulsions have been reported in patients receiving GnRH agonists, including CAMCEVI ETM or CAMCEVI [see Adverse Reactions (6.2)]. Manage patients receiving a GnRH agonist who experience convulsions according to current clinical practice.

5.6 Severe Cutaneous Adverse Reactions

Additions and/or revisions underlined:

CAMCEVI ETM and CAMCEVI can cause 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). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving CAMCEVI ETM or CAMCEVI or other GnRH agonists; including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions (6.2)].

Monitor patients for the development of SCARs.

If a SCAR is suspected, interrupt CAMCEVI ETM or CAMCEVI 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 CAMCEVI ETM or CAMCEVI.

5.7 Laboratory Tests

Additions and/or revisions underlined:

Monitor serum levels of testosterone following injection of CAMCEVI ETM or CAMCEVI. In the majority of patients treated with CAMCEVI ETM or CAMCEVI, testosterone levels increased above baseline during the first week, and then declined thereafter to castration levels (<50 ng/dL) within 4 weeks [see Adverse Reactions (6) and Clinical Studies (14)].

5.8 Embryo-Fetal Toxicity

Additions and/or revisions underlined:

Based on findings in animal studies and mechanism of action, CAMCEVI ETM and CAMCEVI can cause fetal harm when administered to a pregnant woman.

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Allergic Conditions: anaphylactoid or asthmatic process, rash, urticaria, hypersensitivity reactions including anaphylaxis, and photosensitivity reactions

…

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Based on findings in animal studies and mechanism of action, CAMCEVI ETM and CAMCEVI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)].

…

8.2 Lactation

Risk Summary

The safety and efficacy of CAMCEVI ETM and CAMCEVI have not been established in females. There is no information regarding the presence of leuprolide in human milk, the effects on the breast-fed child, or the effects on milk production.

…

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Based on findings in animals and mechanism of action, CAMCEVI ETM and CAMCEVI may impair fertility in males of reproductive potential [see Clinical Pharmacology (12.1), Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and efficacy of CAMCEVI ETM and CAMCEVI in pediatric patients have not been established.

8.5 Geriatric Use

Additions and/or revisions underlined:

CAMCEVI ETM 21 mg for 3-Month Administration:

Of the 144 patients who received CAMCEVI ETM in the FP01C-17-001, 74% were 65 years of age or older, while 31% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients over the age of 65 and younger patients.

CAMCEVI 42 mg for 6-Month Administration:

Of the 137 patients who received CAMCEVI in the FP01C-13-001 study, 74% were 65 years of age or older, while 37% were 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Hypersensitivity

Inform patients that CAMCEVI ETM and CAMCEVI are contraindicated in patients who have experienced hypersensitivity with other GnRH agonist drugs, including CAMCEVI ETM and CAMCEVI [see Contraindications (4)].

Tumor Flare

Inform patients that CAMCEVI ETM and CAMCEVI can cause tumor flare during the first weeks of treatment. Inform patients that the increase in testosterone can cause an increase in urinary symptoms or pain. Advise patients to contact their healthcare provider if ureteral obstruction, spinal cord compression, paralysis, or new or worsened symptoms occur after beginning CAMCEVI ETM or CAMCEVI treatment [see Warnings and Precautions (5.1)].

Hyperglycemia and Diabetes

Advise patients that there is an increased risk of hyperglycemia and diabetes with CAMCEVI ETM and CAMCEVI treatment. Inform patients that periodic monitoring for hyperglycemia and diabetes is required when being treated with CAMCEVI ETM or CAMCEVI [see Warnings and Precautions (5.2)].

Cardiovascular Diseases

Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with CAMCEVI ETM and CAMCEVI treatment. Advise patients to immediately report signs and symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.3)].

QT/QTc Prolongation

Inform patients that CAMCEVI ETM and CAMCEVI can cause QT/QTc prolongation. Advise patients to immediately contact their healthcare provider in the event of syncope, presyncopal symptoms, or cardiac palpitations [see Warnings and Precautions (5.4)].

Convulsions

Inform patients that there is an increased risk of convulsions with CAMCEVI ETM and CAMCEVI treatment. Advise patients to immediately contact their healthcare provider if they experience convulsions [see Warnings and Precautions (5.5)].

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 CAMCEVI ETM and CAMCEVI. Advise patients to contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs, e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy [see Warnings and Precautions (5.6)].

Urogenital Disorders

Advise patients that CAMCEVI ETM and CAMCEVI may cause impotence.

Infertility

Inform patients that CAMCEVI ETM and CAMCEVI may cause infertility [see Use in Specific Populations (8.3)].