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Product Features & Attributes

LUPRON DEPOT offers a proprietary delivery system and formulation designed with you and your patient's experience in mind.

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Watch educational videos, preview and download informational literature, and learn more about LUPRON DEPOT below.
MIXING & ADMINISTERING VIDEO
LUPRON DEPOT ADMINISTRATION
LUPRON DEPOT ADMINISTRATION

Clinical Evidence

LUPRON DEPOT delivers testosterone suppression below castrate levels across multiple formulations, as shown in multicenter clinical trials enrolling patients with histologically confirmed advanced prostate cancer.1

Effective Testosterone Suppression

A graph showing testosterone suppression with 6-month dosingA graph showing testosterone suppression with 6-month dosing
Jackson, a LUPRON DEPOT patient, standing proudly and smiling

Safety With 6-Month Dosing

6-Month Safety6-Month Safety
aIncludes influenza, nasal congestion, nasopharyngitis, rhinorrhea, upper respiratory tract infection, and viral upper respiratory tract infection.
bIncludes basal cell carcinoma, bladder transitional cell carcinoma, lung neoplasm, malignant melanoma, non-Hodgkin lymphoma, and squamous cell carcinoma.
A graph showing testosterone suppression with 4-month dosing A graph showing testosterone suppression with 4-month dosing

Safety With 4-Month Dosing

The 4-month formulation of LUPRON DEPOT 30 mg was utilized in clinical trials that studied the drug in 49 nonorchiectomized prostate cancer patients for 32 weeks or longer and in 24 orchiectomized prostate cancer patients for 20 weeks.
4-Month Safety4-Month Safety

Post Hoc Analysis of Combined 4- and 6-Month Data

Consideration for Testosterone Measurement
  • Based on assays available 40 years ago, surgical castrate levels of testosterone were reported as <50 ng/dL8,9
  • US FDA and American Urological Association (AUA) currently define medical castration as testosterone levels <50 ng/dL10,11
  • Current testosterone assay techniques are more rapid and accurate8
  • Surgical castrate level using current assays determined as median 15 ng/dL (95% Cl: 12-17 ng/dL)8
  • <20 ng/dL is the recommended goal for ADT therapy by the European Association of Urology Guidelines (EAU) 2019 and Bethesda consensus 20119,12
  • No robust clinical data have clearly established the value of achieving testosterone <20 ng/dL8,12
Post hoc analysis of combined 4- and 6-month data, including pooled data
In a combined post hoc analysis of two phase 3 open-label studies in patients with histologically confirmed prostate adenocarcinoma, serum testosterone levels were pooled at each common timepoint to determine the number and proportion of patients who had levels <20 ng/dL. Assays with similar testosterone sensitivity were used.13
Limitations
Post hoc analyses are not powered or tested to demonstrate statistically significant differences in treatment effect. Pooled data limitation: patients with histologically confirmed adenocarcinoma were evaluated. Cancer staging and other patient characteristics (eg, age, prior treatment) may have been different between studies. The relationship between testosterone values and clinical outcomes has not been established.
Pooled Data Pooled Data

Indication1

LUPRON DEPOT® (leuprolide acetate for depot suspension) 7.5 mg for 1‑month, 22.5 mg for 3-month, 30 mg for 4‑month, and 45 mg for 6‑month administration are indicated for the palliative treatment of advanced prostatic cancer.

Important Safety Information1

  • LUPRON DEPOT is contraindicated in patients with hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT.
  • LUPRON DEPOT causes an initial increase in serum testosterone (~50% above baseline) during the first few weeks of treatment. This initial increase can cause:
    • Transient worsening of symptoms, or additional signs and symptoms of prostate cancer.
    • Temporary increase in bone pain in a small number of patients, which can be managed symptomatically.
    • Isolated cases of ureteral obstruction and spinal cord compression, which may contribute to paralysis with or without fatal complications. Observe patients with vertebral metastasis and/or urinary tract obstruction closely.
  • Hyperglycemia and increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in men receiving a GnRH agonist, and manage hyperglycemia or diabetes.
  • An increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists in men, although the risk appears low. Evaluate the risks carefully, including cardiovascular risk factors, when determining prostate cancer treatment. Patients receiving a GnRH agonist should be monitored for signs and symptoms of cardiovascular disease and managed appropriately.
  • Androgen deprivation therapy (ADT) may prolong the QT/QTc interval. Consideration should be given to whether the benefits of ADT 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. Correct electrolyte abnormalities and consider periodic monitoring of electrocardiograms and electrolytes.
  • Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy, including patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications associated with convulsions, such as bupropion and SSRIs. Convulsions have also been reported in the absence of any of the conditions mentioned above.
  • Periodic monitoring of serum testosterone and PSA levels is recommended.
  • LUPRON DEPOT may cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
  • LUPRON DEPOT may impair fertility in males of reproductive potential.
  • In controlled clinical trials of advanced prostatic cancer patients receiving LUPRON DEPOT, the following adverse events occurred in >10% of patients:
    • LUPRON DEPOT 7.5 mg for 1‑month administration: hot flashes/sweats, general pain, edema, urinary disorders, GI disorders, and respiratory disorders.
    • LUPRON DEPOT 22.5 mg for 3‑month administration: hot flashes/sweats, general pain, testicular atrophy, GI disorders, urinary disorders, injection site reactions, and joint disorders.
    • LUPRON DEPOT 30 mg for 4‑month administration: hot flashes/sweats, injection site reactions, general pain, edema, urinary disorders, joint disorders, GI disorders, asthenia, flu syndrome, skin reactions, and headache.
    • LUPRON DEPOT 45 mg for 6‑month administration: hot flush/flushing, upper respiratory tract infection/influenza-like illness, injection site pain/discomfort, and fatigue/lethargy.
US-LUPR-190307
Please see accompanying Full Prescribing Information.
References:
  1. LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc; 2019.
  2. Data on file. AbbVie Inc. ABVRRTI63636.
  3. Nygren O, Olofsson E, Johannson L. NIOSH definition of closed-system drug-transfer devices. Ann Occup Hyg. 2009;53(5):549. doi:10.1093/annhyg/mep030.
  4. Spitz A, Young JM, Larsen L, et al. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012;15(1):93-99. doi:10.1038/pcan.2011.50.
  5. Data on file. AbbVie Inc. ABVRRTI69626.
  6. Sharifi R, Dean Knoll L, Smith J, et al. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998;51(2):271-276. doi:10.1016/S0090-4295(97)00500-1.
  7. Data on file. AbbVie Inc. ABVRRTI69625.
  8. Oefelein M, Feng A, Scolieri M, et al. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000;56(6):1021-1024. doi:10.1016/S0090-4295(00)00793-7.
  9. European Association of Urology. Prostate cancer. https://uroweb.org/guideline/prostate-cancer/#6. Accessed October 8, 2019.
  10. US Food & Drug Administration. Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry. https://www.fda.gov/media/129027/download. Accessed October 8, 2019.
  11. Cookson MS, Roth BH, Dahm P, et al; American Urological Association. Castration-Resistant Prostate Cancer: AUA Guideline. https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline. Approved May 2018. Accessed October 8, 2019.
  12. Djavan B, Eastham J, Gomella L, et al. Testosterone in prostate cancer: the Bethesda consensus. BJU Int. 2012; 110(3):334-352. doi:10.1111/j.1464-410X.2011.10719.x.
  13. Spitz A, Gittelman M, Karsh LI, et al. Intramuscular depot formulations of leuprolide acetate suppress testosterone levels below a 20 ng/dL threshold: a retrospective analysis of two Phase III studies. Res Rep Urol. 2016;8:159-164. doi:10.2147/RRU.S111475.