Current Science

Current Science

ELIGARD® achieves and maintains low castrate testosterone levels across all four doses, including the longest duration available (six-month dose). [1]

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Figure: Testosterone concentration over time

Testosterone target levels

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Table: percentage patients lower than 20 ng/dL across all studies

Current science reflects testosterone target levels of ≤20 ng/dL. [2]

Achieving and maintaining low testosterone (T) to surgical castration level is the goal of androgen deprivation therapy (ADT) for advanced prostate cancer.

ELIGARD achieves low castrate testosterone levels across all doses that reflects current science. [1]

Nadir T levels

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Table: Nadir T of ≤5 ng/dL was achieved in 91% of patients [3]

Current science considers nadir T levels. Nadir serum testosterone or nadir T is the lowest value during androgen deprivation therapy (ADT), and Evidence is accumulating for nadir T levels around prostate cancer treatments. [3] [4] [5] [6] [7] [8]

ELIGARD® achieved low nadir T levels across all pivotal trials nadir T of ≤5 ng/dL was achieved in 91% of patients. [3]

Current assay methodology shows testosterone (T) level post-surgical castration is ≤20 ng/dL. [2]

Serum PSA

Dose7.5 mg22.5 mg30 mg45 mg
Mean PSA reduction at study conclusion94%98%86%97%
Patients with normal PSA at study conclusion94%91%93%95%
Table: Effect of ELIGARD® on serum PSA values

91% to 95% of patients achieved normal serum PSA values at study conclusion. [1]

In all studies, ELIGARD decreased serum PSA in all patients whose baseline values were elevated above normal.

References
  1. ELIGARD® (leuprolide acetate) for injectable suspension, 7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing information. Fort Collins, CO: Tolmar Therapeutics, Inc.; 2016
  2. Shore N, et al., BJU Int 2016.
  3. Pieczonka C, et al., Rev Urol 2018
  4. Bryant AK, McKay RR, Kader AK, Parsons JK, Einck JP, Kane CJ, Mundt AJ, Murphy JD, Rose BS, Sub-castrate testosterone nadir and clinical outcomes in intermediate or high-risk localized prostate cancer, International Journal of Radiation Oncology • Biology • Physics (2019), doi: https://doi.org/10.1016/j. ijrobp.2018.12.001
  5. Suzman, Antonarakis, J Clin Oncol 2016
  6. Klotz, et al., J Clin Oncol 2015
  7. Kamada, et al., J Urol 2015
  8. Nabid et al., Eur Urol Suppl 2017

IMPORTANT SAFETY INFORMATION

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ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits.

May cause fetal harm. ELIGARD may impair fertility in males of reproductive potential.

Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverseevents include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

See package insert for full prescribing and safety information.