Lupron Depot leuprolide acetate Kit
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Gonadotropin Releasing Hormone Receptor Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Leuprolide injection is used to treat certain types of prostate cancer central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy, irregular bleeding) anemia (a lower-than-normal number of red blood cells) caused by uterine fibroids (growths i...
Read the full MedlinePlus article ↗- That's a really common concern, and it's smart to ask. When you first start leuprolide, your testosterone levels actually spike for a week or two before the drug kicks in and bring...
- Why does my doctor say my symptoms might get worse right after starting leuprolide?
- Hot flashes are actually one of the most common side effects in men taking leuprolide — over half of men in clinical studies experienced them. Because leuprolide drops testosterone...
- Will I get hot flashes? I thought that was just a women's issue.
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2,174.170 | — |
| Medicaid paysCMS SDUD · 12 mo | $761.44 | — |
| Medicare drug plans payPart D · Q2 2026 | $2,187.83 | — |
| Medicare Part B allowsASP · J9217 | $160.342 / J9217 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leuprolide Acetate 00781-4003-32 | Sandoz | 1 kit | $197.606 | AP | Availability likely | save 91% |
| Leuprolide Acetate 55150-0478-01 | Eugia | 1 kit | $197.606 | AP | Availability likely | save 91% |
| leuprolide acetate 47335-0936-40 | Sun | 1 kit | $197.606 | AP | Availability likely | save 91% |
| Leuprolide Acetate 70710-1769-03 | Zydus | 1 kit | $197.606 | AP | Availability likely | save 91% |
| Leuprolide Acetate 72664-0611-28 | VGYAAN | 1 kit | $261.318 | AP | FDA listed | save 88% |
| Lupron Depot 00074-3641-03 | AbbVie | 1 kit | $1,821.130 | — | Availability likely | save 16% |
| Lupron Depotthis 00074-3642-03 | AbbVie | 1 kit | $2,174.170 | — | Availability likely | — |
| Lupron Depot 00074-3663-03 | AbbVie | 1 kit | $5,430.930 | — | Availability likely | +150% |
| Lupron Depot 00074-3346-03 | AbbVie | 1 kit | $6,516.300 | — | Availability likely | +200% |
| Fensolvi 62935-0153-50 | TOLMAR | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3473-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-9694-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2108-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2440-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3683-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Leuprolide Acetate Depot 69097-0909-50 | CIPLA | 1 kit | — | — | FDA listed | — |
| Lutrate Depot 83831-0134-01 | Avyxa | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3575-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Leuprolide Acetate 70771-1687-03 | Zydus | 1 kit | — | AP | FDA listed | — |
| Lupron Depot-PED 00074-2282-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3779-03 | AbbVie | 1 kit | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00074-3642-03 You're viewing this | 1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET | $2,174.17 / ea | — | 1989-01-27 | Active |
| 00074-3642-55 | 1 KIT in 1 CELLO PACK (0074-3642-55) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET | $2,174.17 / ea | — | 2026-03-15 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($2,174.17 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00074-3642-03?
What NDC number is used to bill for this package of Lupron Depot leuprolide acetate Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION LUPRON DEPOT must be administered by a healthcare provider. In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of non-metastatic and metastatic castration-resistant prostate cancer. Table 1.
LUPRON DEPOT Recommended Dosing Dosage 7.5 mg for 1-Month Administration 22.5 mg for 3-Month Administration 30 mg for 4-Month Administration 45 mg for 6-Month Administration Recommended dose 1 injection every 4 weeks 1 injection every 12 weeks 1 injection every 16 weeks 1 injection every 24 weeks LUPRON DEPOT must be administered under the supervision of a physician. Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule. ( 2 ) LUPRON DEPOT 7.5 mg for 1-month administration, given as a single intramuscular injection every 4 weeks.
( 2.1 ) LUPRON DEPOT 22.5 mg for 3-month administration, given as a single intramuscular injection every 12 weeks. ( 2.2 ) LUPRON DEPOT 30 mg for 4-month administration, given as a single intramuscular injection every 16 weeks. ( 2.3 ) LUPRON DEPOT 45 mg for 6-month administration, given as a single intramuscular injection every 24 weeks.
( 2.4 ) Figure 1 Figure 2 Figure 3 figure 4 figure 5 Figure 6 Figure 7
2.1LUPRON DEPOT 7.5 mg for 1-Month Administration The recommended dose of LUPRON DEPOT 7.5 mg for 1-month administration is one injection every 4 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics. Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be administered every 4 weeks as a single intramuscular injection.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.5 .
2.2LUPRON DEPOT 22.5 mg for 3-Month Administration The recommended dose of LUPRON DEPOT 22.5 mg for 3-month administration is one injection every 12 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics. Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be administered every 12 weeks as a single intramuscular injection.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.5 .
2.3LUPRON DEPOT 30 mg for 4-Month Administration The recommended dose of LUPRON DEPOT 30 mg for 4-month administration is one injection every 16 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics. Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be administered every 16 weeks as a single intramuscular injection.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.5 .
2.4LUPRON DEPOT 45 mg for 6-Month Administration The recommended dose of LUPRON DEPOT 45 mg for 6-month administration is one injection every 24 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics. Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be administered every 24 weeks as a single intramuscular injection.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.5 .
2.5Reconstitution and Administration for Injection of LUPRON DEPOT Reconstitute and administer the lyophilized microspheres as a single intramuscular injection. Inject the suspension immediately or discard if not used within two hours, because LUPRON DEPOT does not contain a preservative. 1. Visually inspect the LUPRON DEPOT powder. DO NOT USE the sy…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration are each supplied as a kit with a prefilled single-dose dual chamber syringe containing white lyophilized microsphere powder in one chamber and a clear, colorless diluent for reconstitution in the other chamber. 7.5 mg, 22.5 mg, 30 mg, and 45 mg injections in a kit with prefilled dual chamber syringe. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS LUPRON DEPOT is contraindicated in: Hypersensitivity LUPRON DEPOT is contraindicated in individuals with known hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT. Reports of anaphylactic reactions to GnRH agonists have been reported in the medical literature. Hypersensitivity to GnRH, GnRH agonist or any of the excipients in LUPRON DEPOT. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Tumor Flare: Increased serum testosterone (~ 50% above baseline) may occur when initiating treatment with LUPRON DEPOT. Monitor for worsening of prostate cancer symptoms during the first few weeks of treatment. Monitor patients for increased bone pain, neuropathy, hematuria, ureteral obstruction, and spinal cord compression.
Spinal cord compressions may contribute to paralysis with or without fatal complications. ( 5.1 ) Metabolic Syndrome: The use of GnRH agonists may lead to an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease. Monitor for signs and symptoms of metabolic syndrome including lipids, blood glucose level and/or HbA1c and manage according to current treatment guidelines.
( 5.2 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to institutional guidelines. ( 5.3 ) Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval.
Consider risks and benefits. ( 5.4 ) Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to institutional guidelines.
( 5.5 ) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), occurred in patients treated with LUPRON DEPOT. Interrupt LUPRON DEPOT if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed.
( 5.6 ) Embryo-Fetal Toxicity: LUPRON DEPOT may cause fetal harm. ( 5.8 , 8.1 )
5.1Tumor Flare Initially, LUPRON DEPOT, like other GnRH agonists, causes increases in serum levels of testosterone to approximately 50% above baseline during the first weeks of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction. Spinal cord compression may contribute to paralysis with or without fatal complications.
Monitor patients for tumor flare symptoms during the first few weeks of treatment with LUPRON DEPOT. Closely monitor patients with metastatic vertebral lesions and/or with urinary tract obstruction for new or worsening symptoms.
5.2Metabolic Syndrome 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.
5.3Cardiovascular Diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to institutional guidelines.
5.4Effect on QT/QTc Interval Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected.
Consider periodic monitoring of electrocardiograms and electrolytes.
5.5 Convuls…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 )] 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.
LUPRON DEPOT 7.5 mg for 1-month administration: The most common adverse reactions (>10%) were general pain, hot flashes/sweats, GI disorders, edema, respiratory disorder, urinary disorder. ( 6.1 ) LUPRON DEPOT 22.5 mg for 3-month administration: The most common adverse reactions (>10%) were general pain, injection site reaction, hot flashes/sweats, GI disorders, joint disorders, testicular atrophy, urinary disorders. ( 6.2 ) LUPRON DEPOT 30 mg for 4-month administration: The most common adverse reactions (>10%) were asthenia, flu syndrome, general pain, headache, injection site reaction, hot flashes/sweats, GI disorders, edema, skin reaction, urinary disorders.
( 6.3 ) LUPRON DEPOT 45 mg for 6-month administration: The most common adverse reactions (>10%) were hot flush, injection site pain, upper respiratory infection, and fatigue. ( 6.4 ) In postmarketing experience, mood swings, depression, rare reports of suicidal ideation and attempt, rare reports of pituitary apoplexy, and rare reports of serious drug-induced liver injury have been reported. ( 6.5 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1LUPRON DEPOT 7.5 mg for 1-Month Administration In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction or hematuria which, if aggravated, may lead to neurological problems such as temporary weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms [see Warnings and Precautions ( 5.1 )] .
In a clinical trial of LUPRON DEPOT 7.5 mg for 1-month administration, the following adverse reactions were reported in 5% or more of the patients during the initial 24-week treatment period. Table 2. Adverse Reactions Reported in ≥ 5% of Patients LUPRON DEPOT 7.5 mg for 1-Month Administration (N=56) N (%) Body As A Whole General pain 13 (23.2) Infection 3 (5.4) Cardiovascular System Hot flashes/sweats* 32 (57.1) Digestive System GI disorders 8 (14.3) Metabolic and Nutritional Disorders Edema 8 (14.3) Nervous System Libido decreased* 3 (5.4) Respiratory System Respiratory disorder 6 (10.7) Urogenital System Urinary disorder 7 (12.5) Impotence* 3 (5.4) Testicular atrophy* 3 (5.4) * Due to the expected physiologic effect of decreased testosterone levels.
In this same study, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 7.5 mg for 1-month administration. Body As A Whole - asthenia, cellulitis, fever, headache, injection site reaction, neoplasm Cardiovascular System - angina, congestive heart failure Digestive System - anorexia, dysphagia, eructation, peptic ulcer Blood and Lymphatic System - ecchymosis Musculoskeletal System - myalgia Nervous System - agitation, insomnia/sleep disorders, neuromuscular disorders Respiratory System - emphysema, hemoptysis, lung edema, sputum increased Skin and Appendages - hair disorder, skin reaction Urogenital System - balanitis, breast enlargement, urinary tract infe…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drug/Laboratory Test Interactions Administration of LUPRON DEPOT in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Due to the suppression of the pituitary-gonadal system by LUPRON DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUPRON DEPOT may be affected.
🔄 Drug / Laboratory Test Interactions ▾
7.1Drug/Laboratory Test Interactions Administration of LUPRON DEPOT in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Due to the suppression of the pituitary-gonadal system by LUPRON DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUPRON DEPOT may be affected.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Females and males of reproductive potential: LUPRON DEPOT may impair fertility. Counsel patients on pregnancy planning and prevention. ( 8.3 ) Pediatric: These LUPRON DEPOT formulations are not indicated for use in children.
See the LUPRON DEPOT PED ® prescribing information for the use of leuprolide acetate in children with central precocious puberty. Geriatric: This label reflects clinical trials for LUPRON DEPOT in prostate cancer in which the majority of the subjects studied were at least 65 years of age.
8.1Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, LUPRON DEPOT may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies, administration of a monthly formulation of leuprolide acetate on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose based on body surface area using an estimated daily dose (see data) .
Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Data Animal Data Major fetal malformations were observed in developmental and reproductive toxicology studies in rabbits after a single administration of the monthly formulation of leuprolide acetate on day 6 of pregnancy at doses of 0.00024, 0.0024, and 0.024 mg/kg (approximately 1/1600 to 1/16 the human dose based on body surface area using an estimated daily dose in animals and humans). Since a depot formulation was utilized in the study, a sustained exposure to leuprolide was expected throughout the period of organogenesis and to the end of gestation.
Similar studies in rats did not demonstrate an increase in fetal malformations, however, there was increased fetal mortality and decreased fetal weights with the two higher doses of the monthly formulation of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
8.2Lactation The safety and efficacy of LUPRON DEPOT have not been established in females. There is no information regarding the presence of LUPRON DEPOT 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 LUPRON DEPOT, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
8.3Females and Males of Reproductive Potential Infertility Males Based on findings in animals and mechanism of action, LUPRON DEPOT may impair fertility in males of reproductive potential [see Nonclinical Toxicology ( 13.1 )] .
8.4Pediatric Use See LUPRON DEPOT-PED ® (leuprolide acetate for depot suspension) labeling for the safety and effectiveness in children with central precocious puberty.
8.5Geriatric Use In the clinical trials for LUPRON DEPOT in prostate cancer 80% of the subjects studied were at least 65 years of age. Therefore, the labeling reflects the efficacy and safety of LUPRON DEPOT in this population.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, LUPRON DEPOT may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies, administration of a monthly formulation of leuprolide acetate on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose based on body surface area using an estimated daily dose (see data) .
Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Data Animal Data Major fetal malformations were observed in developmental and reproductive toxicology studies in rabbits after a single administration of the monthly formulation of leuprolide acetate on day 6 of pregnancy at doses of 0.00024, 0.0024, and 0.024 mg/kg (approximately 1/1600 to 1/16 the human dose based on body surface area using an estimated daily dose in animals and humans). Since a depot formulation was utilized in the study, a sustained exposure to leuprolide was expected throughout the period of organogenesis and to the end of gestation.
Similar studies in rats did not demonstrate an increase in fetal malformations, however, there was increased fetal mortality and decreased fetal weights with the two higher doses of the monthly formulation of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
🧒 Pediatric Use ▾
8.4Pediatric Use See LUPRON DEPOT-PED ® (leuprolide acetate for depot suspension) labeling for the safety and effectiveness in children with central precocious puberty.
🧓 Geriatric Use ▾
8.5Geriatric Use In the clinical trials for LUPRON DEPOT in prostate cancer 80% of the subjects studied were at least 65 years of age. Therefore, the labeling reflects the efficacy and safety of LUPRON DEPOT in this population.
🆘 Overdosage ▾
10 OVERDOSAGE There is no experience of overdosage in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in dyspnea, decreased activity, and excessive scratching. In early clinical trials with daily subcutaneous leuprolide acetate, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy.
Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.
12.2Pharmacodynamics In humans, administration of leuprolide acetate results in an initial increase in circulating concentrations of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in concentrations of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased concentrations of LH and FSH. In males, testosterone is reduced to castrate concentrations.
In premenopausal females, estrogens are reduced to postmenopausal concentrations. These decreases occur within two to four weeks after initiation of treatment, and castrate concentrations of testosterone in prostatic cancer patients have been demonstrated for more than five years. Leuprolide acetate is not active when given orally.
12.3Pharmacokinetics Absorption LUPRON DEPOT 7.5 mg for 1-Month Administration Following a single injection of LUPRON DEPOT 7.5 mg for 1-month administration to patients, mean plasma measured concentrations were 20 ng/mL at 4 hours and 0.36 ng/mL at 4 weeks. However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study. LUPRON DEPOT 22.5 mg for 3-Month Administration Following a single injection of LUPRON DEPOT 22.5 mg for 3-month administration in patients, mean peak plasma concentrations were 48.9 ng/mL at 4 hours and then declined to 0.67 ng/mL at 12 weeks.
Leuprolide appeared to be released at a constant rate following the onset of steady-state concentrations during the third week after dosing, providing steady plasma concentrations through the 12-week dosing interval. However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study. The initial burst, followed by a decline to a steady-state concentration, was similar to the release pattern seen with the monthly formulation.
LUPRON DEPOT 30 mg for 4-Month Administration Following a single injection of LUPRON DEPOT 30 mg for 4-month administration in sixteen orchiectomized prostate cancer patients, mean plasma concentrations were 59.3 ng/mL at 4 hours and then declined to 0.30 ng/mL at 16 weeks. Mean plasma concentrations from weeks 3.5 to 16 was 0.44 ± 0.20 ng/mL (range: 0.20-1.06). Leuprolide appeared to be released at a constant rate following the onset of steady-state concentrations during the fourth week after dosing, providing steady plasma concentrations throughout the 16-week dosing interval.
However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study. The initial burst, followed by a decline to a steady-state concentration, was similar to the release pattern seen with the other depot formulations. LUPRON DEPOT 45 mg for 6-Month Administration Following a single injection of LUPRON DEPOT 45 mg for 6-month administration in 26 prostate cancer patients, mean peak plasma concentration of 6.7 ng/mL was observed at 2 hours and then declined to 0.07 ng/mL at 24 weeks.
Leuprolide appeared to be released continuously following the onset of steady-state concentrations during the third week after dosing providing steady plasma concentrations through the 24-week dosing interval. The initi…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy.
Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each LUPRON DEPOT kit contains: one prefilled dual-chamber syringe containing needle with LuproLoc® safety device one plunger two alcohol swabs a complete prescribing information enclosure Strength Frequency of Administration Description NDC Number 7.5 mg Every month Single-dose prefilled dual-chamber syringe containing sterile white lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer to be mixed with 1 mL of accompanying clear, colorless diluent.
0074-3642-03 0074-3642-55 22.5 mg Every 3 months Single-dose prefilled dual-chamber syringe containing sterile white lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer to be mixed with 1.5 mL of accompanying clear, colorless diluent. 0074-3346-03 0074-3346-55 30 mg Every 4 months Single-dose prefilled dual-chamber syringe containing sterile white lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer to be mixed with 1.5 mL of accompanying clear, colorless diluent.
0074-3683-03 0074-3683-55 45 mg Every 6 months Single-dose prefilled dual-chamber syringe containing sterile white lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer to be mixed with 1.5 mL of accompanying clear, colorless diluent. 0074-3473-03 0074-3473-55 Store between 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. 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 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection.
The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS .
The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 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. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS .
The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 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. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS .
The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 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. Chemical structure of leuprolide acetate
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like LUPRON DEPOT, LUPRON DEPOT is contraindicated [see Contraindications ( 4 )]. Tumor Flare Inform patients that LUPRON DEPOT 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 bone pain, neuropathy, hematuria, bladder outlet obstruction, spinal cord compression, or new or worsened symptoms occur after beginning LUPRON DEPOT treatment [see Warnings and Precautions ( 5.1 )]. 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 LUPRON DEPOT therapy. Inform patients that periodic monitoring for metabolic changes is required when being treated with LUPRON DEPOT [see Warnings and Precautions ( 5.2 )].
Cardiovascular Disease Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with LUPRON DEPOT 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 )]. 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 LUPRON DEPOT.
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 )] . Injection Site Reactions Inform patients and caregivers that injection site reactions such as pain, induration, abscess, and necrosis may occur with LUPRON DEPOT. Advise patients to contact their healthcare provider if they experience injection site reactions [see Adverse Reactions ( 6.4 , 6.5 )].
Urogenital Disorders Advise patients that LUPRON DEPOT may cause impotence [see Adverse Reactions ( 6 )] . Infertility Inform patients that LUPRON DEPOT may cause infertility [see Use in Specific Populations ( 8.3 )]. Continuation of LUPRON DEPOT Treatment Inform patients that LUPRON DEPOT 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 )].
Manufactured for AbbVie Inc. North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645 LUPRON DEPOT and its design are trademarks of AbbVie Endocrine Inc. © 2026 AbbVie. All rights reserved.
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