one were severe.
*
Expected pharmacological consequences of testosterone suppression.
Study Number AGL9904 AGL9802 AGL9909 AGL0001 AGL0205
Number of patients 120 8 117 90 111
Treatment 1 injection every month up to 6 months 1 injection (surgically castrated patients) 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
Body System Adverse Event Number (Percent)
Body as a Whole Malaise and Fatigue 21 (17.5 %) 7 (6.0%) 12 (13.3%) 13 (11.7%)
Weakness 4 (3.6%)
Nervous System Dizziness 4 (3.3%) 4 (4.4%)
Vascular Hot flashes/sweats 68 (56.7%)* 2 (25.0%)* 66 (56.4%)* 66 (73.3%)* 64 (57.7%)*
Renal/Urinary Urinary frequency 3 (2.6%) 2 (2.2%)
Nocturia 2 (2.2%)
Gastrointestinal Nausea 4 (3.4%) 2 (2.2%)
Gastroenteritis/colitis 3 (2.5%)
Skin Pruritis 3 (2.6%)
Clamminess 4 (4.4%)*
Night sweats 3 (3.3%)* 3 (2.7%)*
Alopecia 2 (2.2%)
Musculoskeletal Arthralgia 4 (3.4%)
Myalgia 2 (2.2%) 5 (4.5%)
Pain in limb 3 (2.7%)
Reproductive Testicular atrophy 6 (5.0%) 4 (4.4%)* 8 (7.2%)*
Gynecomastia 2 (2.2%)* 4 (3.6%)*
Testicular pain 2 (2.2%)
Psychiatric Decreased libido 3 (3.3%)*
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.
Body System Adverse Event
*
Expected pharmacological consequences of testosterone suppression.
General Sweating, insomnia, syncope, rigors, weakness, lethargy
Gastrointestinal Flatulence, constipation, dyspepsia
Hematologic Decreased red blood cell count, hematocrit and hemoglobin
Metabolic Weight gain
Musculoskeletal Tremor, backache, joint pain, muscle atrophy, limb pain
Nervous Disturbance of smell and taste, depression, vertigo
Psychiatric Insomnia, depression, loss of libido*
Renal/Urinary Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated
Reproductive/
Urogenital: Testicular soreness/pain, impotence*, decreased libido*, gynecomastia*, breast soreness/tenderness*, testicular atrophy*, erectile dysfunction, penile disorder*, reduced penis size
Skin Alopecia, clamminess, night sweats*, sweating increased*
Vascular Hypertension, hypotension
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 an LH-RH agonist analog.3 It can be anticipated that long periods of medical castration in men will have effects on bone density.
3Hatano T et al. Incidence of bone fracture in patients receiving luteinizing hormone-releasing hormone agonists for prostate cancer. BJU International 2000 86: 449–452.
Post-Marketing
Pituitary apoplexy
During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome |
