LUPRON DEPOT
SAFETY AND EFFICACY

Lupron Depot delivers testosterone suppression
below castrate levels across all formulations

LUPRON DEPOT
45 mg for

LUPRON DEPOT
30 mg for

LUPRON DEPOT
22.5 mg for

LUPRON DEPOT
7.5 mg for

LUPRON DEPOT: A legacy that began in 1985

LUPRON DEPOT dosing options offer individualized treatment
for your advanced prostate cancer patients

LUPRON DEPOT
45 mg for
6-month
administration

+

Mean serum testosterone at Week 4:
Below castrate level at 15.9 ng/dL

+

Mean serum testosterone after Week 4 was suppressed below 15 ng/dL for the remainder of the 48-week treatment period and was ≤11 ng/dL at the end of each treatment cycle

Clinical Study Design1,2

Open-label, non-comparative, multicenter study of 151 patients with prostate cancer. LUPRON DEPOT 45 mg was given by two intramuscular injections at 24-week intervals (139/151 of the patients received two injections). Patients were followed for a total of 48 weeks.

Primary Endpoint1,2

Serum testosterone was suppressed to ≤50 ng/dL from Week 4 through Week 48 in an estimated 93.4% of patients (two-sided 95% Cl: 89.2%, 97.6%, N=148)

LUPON DEPOT 45 MG FOR 6-MONTH ADMINISTRATION:
ADVERSE EVENTS IN >5% OF PATIENTS1

 

LUPRON DEPOT
30 mg for
4-month
Administration

+

Mean serum testosterone at Week 4:
Below castrate level at 15.6 ng/dL (SD=16, N=47)

+

Mean serum testosterone at Week 32: 11.3 ng/dL (SD=5.1, N=35)
After falling to 10.7 ng/dL by Week 6, mean serum testosterone fluctuated between 9.7 ng/dL and 21.0 ng/dL from Week 6 to Week 32

Clinical Study Design1,3

An Open-label, non-comparative, multicenter clinical study assessed 49 patients with stage D2 prostatic adenocarcinoma who received LUPRON DEPOT 30 mg intramuscularly every 16 weeks. The study included a 32-week treatment phase and a long-term treatment phase continued at the investigator's discretion.

Primary Endpoint1,3

Castrate levels were achieved in 94% of patients by Day 30, and in all patients by Day 43. After falling to castrate range, mean testosterone levels remained within the castrate range throughout each dosing interval.

LUPON DEPOT 30 MG FOR 4-MONTH ADMINISTRATION:
ADVERSE EVENTS IN >5% OF PATIENTS1

LUPRON DEPOT
22.5 mg for
3-month
Administration

+

Mean serum testosterone at Week 4:
Below castrate level at 21.3 ng/dL (N=86)

+

Mean serum testosterone at Week 24: 16.7 ng/dL (N=55)

Clinical Study Design1,5

Two nearly identical open-label multicenter studies evaluated LUPRON DEPOT 22.5 mg administered IM every 12 weeks to patients with stage D2 prostate cancer. Clinical evaluations were performed every 12 weeks and serum testosterone levels were monitored biweekly or weekly for 24 weeks.

Primary Endpoint5

Castrate levels (50 ng/dL) of testosterone were achieved within 30 days of the initial injection in 95% (87/92) of patients in the two studies. After falling to castrate range, mean testosterone levels remained within the castrate range throughout each 12-week dosing interval.

LUPON DEPOT 22 MG FOR 3-MONTH ADMINISTRATION:
ADVERSE EVENTS IN >5% OF PATIENTS1

LUPRON DEPOT
7.5 mg for
1-month
Administration

+

Mean serum testosterone at Week 3: Below castrate level at 33.8 ng/dL (SD=26.2, N=52)

+

Mean serum testosterone at Week 4: Below castrate level at 17.0 ng/dL (SD=9.9, N=52)

+

Mean serum testosterone at Week 24: 23.7 ng/dL (SD=89.9, N=46)

Clinical Study Design1,7

An open-label, non-comparative, multicenter study assessed 56 patients with stage D2 prostate cancer to determine in LUPRON DEPOT 75 mg injected once every 4 weeks would reduce serum testosterone levels to and maintain them at castrate levels (<50 ng/dL), and to assess safety.

Primary Endpoint1,7

Serum testosterone was suppressed to castrate range (<50 ng/dL) within 30 days of the initial injection in 94% (51/54) of patients for whom suppression was achieved within 66 days in all 54 patients. Mean serum testosterone was suppressed to castrate level by week 3.

LUPON DEPOT 7.5 MG FOR 1-MONTH ADMINISTRATION:
ADVERSE EVENTS IN >5% OF PATIENTS1

Our Commitment to Your Patients and Practice:
A Legacy that Began in 1985

GnRHa=gonadotrophin-releasing hormone agonist; mCRPC=metastatic castration-resistant prostate cancer; nmCRPC=non-metastatic castration-resistant prostate cancer.

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-181869

Please click here for Full Prescribing information.

US-LUPR-181869

References: 1. LUPRON DEPOT® [package insert]. North Chicago, IL: AbbVie Inc. 2. 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. 3. Sharifi R, Dean Knoll L, Smith J, Kramolowsky E. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998;51(2):271-276. 4. Data on file, AbbVie Inc. ABVRRTI63963. 5. Sharifi R, Bruskewitz RC, Gittleman MC, Graham SD Jr, Hudson PB, Stein B. Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996;18(4):647-657. 6. Data on file, AbbVie Inc. ABBRRTI63945. 7. Sharifi R, Soloway M. Clinical study of leuprolide depot formulation in the treatment of advanced prostate cancer. The Leuprolide Study Group. J Urol. 1990;143(1):68-71. 8. Data on file, AbbVie Inc. ABBRRTI63942. 9. Orange Book product details for NDA 019010. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=019010. Accessed February 11, 2019. 10. Orange Book product details for NDA 019732. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=019732. Accessed February 11, 2019. 11. Orange Book product details for NDA 020517. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020517. Accessed February 11, 2019. 12. Data on file, AbbVie Inc. LuproLink clinic count. August 31, 2015. 13. Data on file, AbbVie Inc. LuproLink clinic count. April 21, 2015.

US-LUPR-190110

Important Safety Information1

  • LUPRON DEPOT® (leuprolide acetate for depot suspension) 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-181869

Please click here for Full Prescribing information.

Indication 1

LUPRON DEPOT 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® (leuprolide acetate for depot suspension) 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

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-190024

Please click here for Full Prescribing information.

Important Safety Information1

LUPRON DEPOT® (leuprolide acetate for depot suspension) 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 

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