Efficacy

Efficacy

ELIGARD® delivers powerful and sustained testosterone suppression that reflects current science.

One open-label, multicenter study was conducted with each ELIGARD formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A through D prostate cancer who were treated with at least a single injection of study drug. These studies evaluated the achievement and maintenance of castrate serum testosterone suppression over the duration of therapy.

Castrate levels in 2-4 weeks

Testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second or third week in the majority of patients. Castrate levels were generally reached within two to four weeks.

Castrate levels maintained

Castrate testosterone levels were maintained for the duration of the treatment with ELIGARD 7.5 mg. No increases above the castrate level occurred in any of the patients.

Castrate levels were maintained for the duration of treatment with ELIGARD 22.5 mg with only one patient demonstrating breakthrough following 1st injection; that patient remained at castrate levels following the second injection.

Once castrate levels were achieved with ELIGARD 30 mg, most (86/89) patients remained suppressed throughout the study.

Once castrate levels were achieved with ELIGARD 45 mg, only one patient (< 1%) experienced a breakthrough, with testosterone levels > 50 ng/dL.

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ELIGARD (leuprolide acetate) for injectable suspension maintains castrate testosterone levels across all four doses, including the longest duration available (6-month dose).

Table: Testosterone concentration over time

Serum PSA decrease

Serum PSA decreased in all patients in all studies whose baseline values were elevated above the normal limit. [1]

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

Response to ELIGARD should be monitored by periodic measurement of serum concentrations of testosterone and prostate specific antigen.

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%
In all studies, ELIGARD decreased serum PSA in all patients whose baseline values were elevated above normal. [1]
Table: Effect of ELIGARD® on serum PSA values
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

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.