Activate ELIGARD’s Clinical Effect

Activate ELIGARD’s Clinical Effect

Through Correct Mixing and Administration2

Room temperature thermometer

Preparation

Allow the product to reach room temperature before using

Mixing icon

Mixing

Thoroughly mix the product for approximately 45 seconds

90 degree angle icon

Administration

Inject ELIGARD at a 90° angle

Handling and Preparation2

IMPORTANT: ELIGARD must be brought to room temperature before mixing.

Room Temperature Icon

  • Make sure patient is in the treatment room, as ELIGARD must be administered within 30 minutes of mixing
  • Always wash your hands and use gloves
  • Open both ELIGARD packages
  • Discard the desiccant packs from each package and ensure all contents are in place. You are now ready to assemble and mix ELIGARD
Assembly2

1 Open both ELIGARD packages

On a clean field open both trays, discard the desiccant packs from each package and ensure all contents are in place. You are now ready to assemble and mix ELIGARD.

Tray Contents

2 Start with Syringe B: Pull out blue plunger

Pull out the short blue plunger rod with attached gray stopper from Syringe B and discard.

Syringe B

3 Insert the long white plunger rod from Syringe A package

Gently insert the long white plunger rod from the Syringe A package into the gray primary stopper inside Syringe B by twisting it into place.

White plunger

4 Remove caps

  • Unscrew the clear cap from Syringe A and remove the gray rubber cap from Syringe B.
  • Discard both caps.
Remove Caps

5 Join the syringes

  • Join the two syringes together by pushing Syringe A into Syringe B and twisting until secure.
  • Be careful not to over tighten.
Join the syringes
Mixing2

Mix contents

Inject the liquid contents of Syringe A into Syringe B (which contains the leuprolide acetate powder).
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Mix contents
  • Thoroughly mix the product by pushing back and forth between the syringes for about 45 seconds to obtain a uniform suspension.
  • NOTE: Product must be mixed as described to ensure a uniform suspension is achieved. Shaking will not provide adequate mixing of the product.
  • When thoroughly mixed, the suspension will appear colorless to pale yellow or light tan to tan in color (depending on the strength).

Remove Syringe A

Hold syringes vertically with Syringe B on the bottom. Syringes should remain securely coupled. Draw all the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.

    Remove syringe A

    Uncouple syringes

    • Uncouple Syringe A while continuing to push down on the Syringe A plunger.
    • Small air bubbles will remain in the formulation (this is acceptable)

    Uncouple syringes

    Attach the sterile needle provided

    • Hold Syringe B upright.
    • Hold back the white plunger on Syringe B to prevent loss of product.
    • Holding the needle in its protective sheath, twist the syringe clockwise until the needle is fully seated. Be careful not to over tighten the needle or it will become stripped.
    • Move the safety sheath away from needle and pull off needle cover.
    • You are now ready to inject!

    Attach sterile needle

     
    Administration2

    10Choosing an injection site

    • Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with belt or clothing waistband).
    • Choose an area that has not recently been used for injection. Cleanse the area with an alcohol swab.
    Subcutaneous Administration

    11Administer injection

    • Using the thumb and forefinger of your non-dominant hand, grasp an area of skin around the injection site.
    • Using your dominant hand, insert needle quickly at a 90° angle, then release the skin with your non-dominant hand; inject the drug using a slow, steady push. Withdraw the needle quickly at the same 90° angle of insertion.
    Administer injection at 90 degree angle

    12Activate needle safety shield

    Activate the needle’s safety shield by using a thumb, finger or flat surface to push the shield forward until it covers the needle. It should lock into place with a click you can hear and feel. Discard all components in an appropriate biohazard container.

    Activate needle safety shield
    See the simple steps to mix and Administer ELIGARD

    See how to correctly prepare, mix and administer ELIGARD

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    IMPORTANT SAFETY INFORMATION

    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. 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.

    INDICATION

    ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.

    Please see full Prescribing Information for ELIGARD.

    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