PROVEN Efficacy

 

CONSIDER CURRENT SCIENCE AROUND NADIR T SUPPRESSION LEVELS

nadir - The lowest point

Current science doesn’t just reflect T targets of <20 ng/dL, it also considers lowest T levels, also known as nadir T1

 

Evidence of nadir T level around prostate cancer treatments

Nadir serum testosterone or nadir T is the lowest value during androgen deprivation therapy (ADT)1

Bryant et al. Int. J Radiat Oncol Biol Phys. 20192

Sub-castrate testosterone nadir and clinical outcomes in intermediate or high-risk localized prostate cancer

Suzman, Antonarakis. J Clin Oncol. 20153

Does degree of androgen suppression matter in hormone-sensitive prostate cancer?

Pieczonka et al. Rev Urol. 20181

Effectiveness of subcutaneously administered leuprolide acetate to achieve low nadir testosterone in prostate cancer patients

Klotz et al. J Clin Oncol. 20154

Nadir testosterone within first year of androgen-deprivation therapy (ADT) predicts for time to castration-resistant progression: a secondary analysis of the PR-7 trial of intermittent versus continuous ADT

Nabid et al. Eur Urol Suppl. 20175

Does nadir testosterone at the end of long term androgen deprivation therapy predict outcomes in high risk prostate cancer? Data from a phase Ill trial

Kamada et al. J Urol. 20156

Nadir testosterone after long-term followup predicts prognosis in patients with prostate cancer treated with combined androgen blockade

 

eligard ACHIEVED PROFOUND T SUPPRESSION ACROSS 1-, 3-, 4-, AND 6-MONTH DOSES7

The percentage of patients achieving serum testosterone concentration of ≤20 ng/dL across all studies*7

*Data from week 3 time point excluded as it reflects initial T surge and not final levels of suppression

 

 

Mean testosterone level (ng/dL) achieved across all doses at study conclusion8

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

Increasing evidence suggests that the historical target threshold for serum testosterone concentration when using ADT in treating advanced prostate cancer (≤50 ng/dL) is not equivalent to the concentrations achieved by surgical castration.“7

— Shore et al 2016
2012 Bethesda (US) Consensus9

Recommends 20 ng/dL for serum T during ADT in patients with advanced PCa as levels between 20 ng/dL and 50 ng/dL have worst clinical outcomes

2016 EAU Guidelines10

Define target for T during ADT as <20 ng/dL

2018 Canadian Urologic Association Consensus11

Encourages adoption of ≤20 ng/dL as castrate level. Recommends regular monitoring of T and PSA (3m–6m) as clinically appropriate during ADT and to reassess strategy if T not suppressed or PSA rises regardless of adequate T suppression

 

LOW OCCURENCE OF T MICROSURGES*1

Incidence of microsurges within 4 weeks after second dose

Pooled incidence of >50 microsurges was 2 out of 424 throughout the studies1

*Microsurge: absolute increase in T >25 ng/dL within 4 weeks after second dose

ELIGARD, a long-acting injectable, can help12

ENSURE

treatment
adherence

PROVIDE

reliable and controlled T suppression

REDUCE

the possibility of T breakthroughs

 

eligard Helps achieve PSA goals

In all studies, ELIGARD decreased serum PSA in all patients whose baseline values were elevated above normal8

91-95 percent of patients

PSA levels are a good indicator of disease progression but measuring T levels ensures your patient continues to achieve the goal of ADT

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)—Prostate Cancer13

For patients with metastatic prostate cancer, NCCN guidelines recommend ADT with treatment intensification, and ADT alone may be appropriate for some patients.

This recommendation is based on the data showing improved survival in newly diagnosed patients with metastatic prostate cancer with a PSA value ≤4 ng/mL after 7 months of ADT.

Consider our well-established safety profile

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IMPORTANT SAFETY INFORMATION

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.