March 2023 - ELIGARD® Information Center

Month: March 2023

Contents of Packaging

Contents of Packaging ELIGARD is packaged in a carton containing the pre-connected syringe system and a safety needle:

Preparation

Preparation Important Allow the product to reach room temperature before mixing. Though ELIGARD is shipped refrigerated, it can be stored for up to eight (8) weeks at room temperature. Once mixed, the product must be administered within 30 minutes or it should be discarded. Use aseptic technique ...

Mixing

Mixing Is your ELIGARD correctly prepared? If not, go back to Step 1: Preparation Follow the step-by-step instructions below, or watch the full mixing & administration training video. Step 2 – Mix

Administration

Administration Step 3 – Administration ELIGARD can be injected on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that hasn’t recently been used. Avoid areas with excessive pigment, nodules, lesions, or hair. Would you like a mixing & admini...

Tips & Troubleshooting

Tips & Troubleshooting Tips for injecting ELIGARD Set expectations with your patient while mixing ELIGARD ELIGARD must be mixed for 60 cycles, so this is a great time to let the patient know what to expect. For example, you can tell them: Troubleshooting If ELIGARD is very difficult to mix an...

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.