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Innovative Delivery System

Innovative Delivery System

polymeric gel extended delivery system
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polymeric gel extended delivery system
In-situ polymeric gel extended delivery system

ELIGARD® offers uniquely innovative technology in leuprolide acetate delivery. The polymeric gel delivery system is an innovative, controlled-release delivery system designed to continuously release leuprolide acetate from an in situ formed solid implant over a one-, three-, four- or six-month dosing period. After injection, the unique polymeric gel delivery system forms a solid implant in situ, enabling sustained and controlled release of leuprolide acetate as it safely biodegrades. [1]

The extended delivery system contains a unique biodegradable polymer of D, L-lactide-co glycolide dissolved in N-methyl-2-pyrrolidone. Optimization of the polymer matrix ratios enables extended release dosing formulations, resulting in continuous gonadotropin and testosterone suppression across one-, three-, four- or six-months with very low injection volumes. [2]

References
  1. Sartor O. Eur Urol 2006
  2. 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®, (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.