The safety of all ELIGARD® formulations was eva luated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of ELIGARD® 7.5 mg was eva luated in 8 surgically castrated males (Table 7). ELIGARD®, like other LH-RH 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 (see WARNINGS and PRECAUTIONS ).

During the clinical trials, injection sites were closely monitored. Refer to Table 6 for a summary of reported injection site 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 7). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.

In addition, the following possibly or probably related systemic adverse events were reported by < 2% of the patients treated with ELIGARD® in these clinical studies.

Table 6 Reported Injection Site Adverse Events  7.5 mg 22.5 mg 30 mg 45 mg
Study Number AGL9904 AGL9909 AGL0001 AGL0205
Number of patients 120 117 90 111
Treatment 1 injection every month up to 6 months 1 injection every 3 months up to 6 months 1 injection every 4 months up to 8 months 1 injection every 6 months up to 12 months
Number of injections 716 230 175 217
 
Transient burning/stinging 248 (34.6%) injections;84% reported as mild 50 (21.7%) injections; 86% reported as mild 35 (20%) injections; 100% reported as mild 35 (16%) injections; 91.4% reported as mildFollowing injection of ELIGARD® 30 mg, three of the 35 burning/stinging events were reported as moderate. 
Pain (generally brief and mild) 4.3% of injections (18.3% of patients) 3.5% of injections (6.0% of patients) 2.3% of injectionsA single event reported as moderate pain resolved within two minutes and all 3 mild pain events resolved within several days following injection of ELIGARD® 30 mg. (3.3% of patients) 4.6% of injectionsTransient pain was reported as mild in intensity in nine of ten (90%) events and moderate in intensity in one of ten (10%) events following injection of ELIGARD® 45 mg. 
Erythema (generally brief and mild) 2.6% of injections (12.5% of patients) 0.9% of injectionsErythema was reported following 2 injections of ELIGARD® 22.5 mg. One report characterized the erythema as mild and it resolved within 7 days. The other report characterized the erythema as moderate and it resolved within 15 days. Neither patient experienced erythema at multiple injections. (1.7% of patients) 1.1% of injections (2.2% of patients) 
Bruising (Mild) 2.5% of injections (11.7% of patients) 1.7% of injections (3.4% of patients)  2.3% of injectionsMild bruising was reported following 5 (2.3%) study injections and moderate bruising was reported following 2 (<1%) study injections of ELIGARD® 45 mg.&