Current Science

Current Science

ELIGARD® achieves and maintains low 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 for castration 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 testosterone levels across all doses that reflects current science. [1]

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

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]

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 who had elevated levels at baseline.

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.; 2019
  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®, (leuprolide acetate) for injectable suspension, is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonists 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. Monitor patients at risk closely and manage as appropriate.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. 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 agonists 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. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.

ELIGARD may impair fertility in males of reproductive potential.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events 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.

Please see full Prescribing Information for ELIGARD and full Prescribing Information for ELIGARD with Pre-connected Syringe System.