Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
For Injection: 11.25 mg of leuprolide acetate as a white lyophilized microsphere powder for reconstitution in a single dose prefilled dual chamber syringe; with one chamber containing the lyophilized powder and the other chamber containing the clear diluent.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
LUPRON DEPOT 11.25 mg is contraindicated in women with the following: Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 11.25 mg [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.2 ) ] Undiagnosed abnormal uterine bleeding Pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 ) ] When norethindrone acetate is administered with LUPRON DEPOT 11.25 mg, the contraindications to the use of norethindrone acetate also apply to this combination regimen. Refer to the norethindrone acetate prescribing information for a list of contraindications for norethindrone acetate.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following clinically significant adverse reactions are described elsewhere in the labeling: Loss of Bone Mineral Density [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Initial Flare of Symptoms with Management of Endometriosis [see Warnings and Precautions ( 5.5 )] Convulsions [see Warnings and Precautions ( 5.6 )] Clinical Depression [see Warnings and Precautions ( 5.7 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
No drug-drug interaction studies have been conducted with LUPRON DEPOT 11.25 mg.
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone [GnRH or luteinizing hormone releasing hormone (LH-RH)], a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension for injection) is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres powder which, when mixed with diluent, become a suspension intended as an IM injection. The front chamber of LUPRON DEPOT 11.25 mg prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (11.25 mg), polylactic acid (99.3 mg) and D-mannitol (19.45 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. During the manufacture of LUPRON DEPOT 11.25 mg, acetic acid is lost, leaving the peptide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
The safety and efficacy of LUPRON DEPOT 11.25 mg for the indicated populations has been established based on adequate and well-controlled studies in adults (See Table 8 ) of LUPRON DEPOT 3.75 mg and on a single trial of LUPRON DEPOT 11.25 mg [see Indications and Usage ( 1 )].
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Each LUPRON DEPOT 11.25 mg kit (NDC 0074-3663-03) contains: one prefilled dual-chamber syringe one plunger two alcohol swabs Each single-dose dual chamber syringe contains sterile white lyophilized microsphere powder of 11.25 mg of leuprolide acetate incorporated in a biodegradable polymer in one chamber and a colorless diluent (1.5 mL) in the other chamber. When mixed with the diluent, LUPRON DEPOT 11.25 mg for injection, is administered as a single IM injection. Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Loss of Bone Density Advise patients about the risk of loss of bone mineral density and that treatment is limited [see Dosage and Administration ( 2.1 ) ] . Advise patients about other factors that can increase and decrease their risk of bone mineral density loss [see Warnings and Precautions ( 5.1 ) ] . Embryo-Fetal Toxicity Advise females of reproductive potential of the possible risk to a fetus. Advise patients to inform healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Special Populations ( 8.1 ) ] . If contraception is indicated, advise females of reproductive potential to use non-hormonal contraception during treatment with LUPRON DEPOT 11.25 mg [see Use in Special Populations ( 8.3 ) ] . Severe Cutaneous Adverse Reactions Inform patients that severe cutaneous adverse reactions (SCARs), may occur during treatment with LUPRON DEPOT 11.25 mg. Advise patients to discontinue LUPRON DEPOT 11.25 mg and to immediately contact their healthcare provider if they experience signs or symptoms of SCARs [see Warnings and Precautions ( 5.3 ) ]. Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including anaphylaxis, have been reported with LUPRON DEPOT. Advise patients to seek appropriate medical care if symptoms of hypersensitivity reactions occur [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.2 ) ]. Initial Flare of Symptoms Advise patients that they may experience an increase in symptoms during the initial days of therapy. Advise patients that these symptoms should dissipate with continued therapy [see Warnings and Precautions ( 5.5 ) ]. Convulsions Inform patients that convulsions have been reported in patients who have received LUPRON DEPOT. Advise patients to seek medical attention in the event of a convulsion [see Warnings and Precautions ( 5.6 ) ] . Clinical Depression Inform patients that depression may occur or worsen during treatment with GnRH agonists, including LUPRON DEPOT 11.25 mg, especially in patients with a history of depression. Advise patients to immediately report thoughts and behaviors of concern to healthcare providers [see Warnings and Precautions ( 5.7 ) ] . Manufactured for AbbVie Inc. North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645 Revised 09/2025 20085415
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0074-3663-03 FOR ADULT USE 11.25 mg for 3-Month administration Single Dose Administration Kit with prefilled dual-chamber syringe. LupronDepot ® (leuprolide acetate for depot suspension) 11.25 mg for 3-Month administration FOR INTRAMUSCULAR INJECTION The front chamber contains: leuprolide acetate 11.25 mg, polylactic acid 99.3 mg, D-mannitol 19.45 mg The second chamber contains: D-mannitol 75.0 mg, carboxymethylcellulose sodium 7.5 mg, polysorbate 80 1.5 mg, water for injection, USP, and glacial acetic acid, USP to control pH Rx only
