Articles by Eligard

Contraindications

Contraindications Hypersensitivity 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.

Warnings & Precautions

Warnings and Precautions Tumor flare ELIGARD® 7.5 mg, 22.5 mg, and 30 mg, like other GnRH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. ELIGARD 45 mg causes a transient increase in serum concentrations of testosterone during the ...

Adverse Reactions

Adverse Reactions ELIGARD® has a well-established safety profile. Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases...

Specific Populations

Specific Populations Pregnancy Risk summary Based on findings in animal studies and mechanism of action, ELIGARD® may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology]. There are no available data in pregnant women to inform the drug-associated risk. Expected horm...

Overdosage

Overdosage In clinical trials in patients with prostate cancer using daily subcutaneous injections of leuprolide acetate and doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.

Cold Storage & Shipping

Cold Storage & Shipping ELIGARD is shipped refrigerated. Store at 35.6 – 46.4 °F (2 – 8 °C). Once outside the refrigerator this product may be stored in its original packaging at room temperature 15 – 30 °C (59 – 86 °F) for up to eight weeks prior to mixing and administration.

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.