Eligard Drug Information

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

ELIGARD ® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation. Table 1.

ELIGARD ® Recommended Dosing As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injections were administered in the upper- or mid-abdominal area.

As with other similar agents, the use of gloves is recommended during mixing and administration. 1 Allow the product to reach room temperature before mixing. Once mixed, the product must be administered within 30 minutes or it should be discarded. ELIGARD ® is packaged in a carton containing two thermoformed trays and this package insert: Table 2: Contents of the Two Trays in the ELIGARD ® Carton Follow the detailed instructions below to ensure correct preparation of ELIGARD ® prior to administration: 11.

Move the safety sheath away from the needle and towards the syringe and pull off the clear needle cartridge cover immediately prior to administration. Note: Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged needle should NOT be replaced and the product should NOT be injected.

In the event of damage to the needle hub, use a new replacement ELIGARD ® carton. Using the thumb and forefinger, grab and bunch the area of skin around the injection site. 4. Withdraw the needle quickly at the same 90° angle used for insertion. 7.

Immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place. 8.

Clinical Trial Experience

The safety of all ELIGARD ® formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of ELIGARD ® 7.5 mg was evaluated in 8 surgically castrated males (Table 5). ELIGARD ®, like other GnRH analogs, caused a transient increase in serum testosterone concentrations during the first one to two weeks of treatment.

Therefore, potential exacerbations of signs and symptoms of the disease during the first weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms. During the clinical trials, injection sites were closely monitored.

Refer to Table 4 for a summary of reported injection site events. Table 4. Reported Injection Site Adverse Events These localized adverse events were non-recurrent over time.

No patient discontinued therapy due to an injection site adverse event. The following possibly or probably related systemic adverse events occurred during clinical trials with ELIGARD ®, and were reported in > 2% of patients (Table 5). Often, causality is difficult to assess in patients with metastatic prostate cancer.

Reactions considered not drug-related are excluded. Table 5. Summary of Possible or Probably Related Systemic Adverse Events Reported by > 2% of Patients Treated with In addition, the following possibly or probably related systemic adverse events were reported by < 2% of the patients treated with Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist analog.

It can be anticipated that long periods of medical castration in men will have effects on bone density.

Postmarketing Experience

Pituitary apoplexy-During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse.

Immediate medical attention has been required. Nervous System-Convulsions Respiratory System-Interstitial lung disease

No pharmacokinetic drug-drug interaction studies were conducted with ELIGARD ®.

Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, ELIGARD ® may cause fetal harm when administered to a pregnant woman. 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.

In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus (see Data). 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.

Pediatric Use The safety and effectiveness of ELIGARD ® in pediatric patients have not been established.

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.

In clinical trials using daily subcutaneous injections of leuprolide acetate in patients with prostate cancer, 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.