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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 hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss.

Animal data

In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation.

There were increased fetal mortality and decreased fetal weights in rats and rabbits.

The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug.

Lactation

The safety and efficacy of ELIGARD have not been established in females. There is no information regarding the presence of ELIGARD in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from ELIGARD, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Individuals of reproductive potential

Based on mechanism of action, ELIGARD may impair fertility in males of reproductive potential [see Clinical Pharmacology].

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

The majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older.

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.