Description

Effective testosterone suppression

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

Effective testosterone suppression

ELIGARD’s innovative in-situ polymeric gel extended delivery system provides controlled drug release enabling consistent suppression of testicular testosterone synthesis throughout the dosing period. [1]

Learn more about ELIGARD’s Clinical Data here.

Clinical Data

Flexible dosing

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ELIGARD flexible dosing

Flexible dosing

ELIGARD offers four (4) dosing options to meet different patient needs. [2]

Learn more about ELIGARD’s Dosage Options here.

Dosage Options

Enhanced patient experience

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Subcutaneous injection

Enhanced patient experience

ELIGARD’s subcutaneous injection allows for numerous injection sites contributing to the patient’s comfort level. [3]

Benefits of subcutaneous (SC) injection include:

For patients…

  • Is safe for people taking anticoagulants
  • Provides a wide range of injection site options
    Avoids muscle soreness
  • Is suitable for patients with little muscle mass
  • Has a low risk of bone or nerve damage

For health care professionals…

  • Allows for flexibility in site of care — can be administered in semi-private settings (e.g., infusion center)
  • Is easy to administer to patients in wheelchairs
  • Is safe for patients who are on anticoagulants
  • Is suitable for patients with little muscle mass
  • Has a lower risk of bone or nerve damage

Chemical makeup

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Chemical makeup of leuprolide acetate

Leuprolide acetate has been used to treat patients with advanced prostate cancer for over 30 years. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH).

When given continuously, it:

  • inhibits pituitary gonadotropin secretion
  • suppresses testicular and ovarian steroidogenesis.

The analog possesses greater potency than the natural hormone.

The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt).

USP <800> considerations

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is only applicable in the context of compounding. ELIGARD is a conventionally manufactured product, and preparation in accordance with the approved labeling for administration to an individual patient is not considered compounding. Therefore, USP <800> does not apply to the mixing and administration of ELIGARD.

FDA approval

ELIGARD is indicated for the palliative treatment of advanced prostate cancer. The one-month, three-month, four-month, and six-month formulations received FDA approval in Jan 2002, July 2002, Feb 2003 and Dec 2004, respectively.

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.
  3. Prettyman J. Urologic Nursing 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.