Eligard (Leuprolide Acetate) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Prostate Cancer »

What is the prostate gland?

The prostate gland is an organ that is located at the base or outlet (neck) of the urinary bladder. (See the diagram that follows.) The gland surrounds the first part of the urethra. The urethra is the passage through which urine drains from the bladder to exit from the penis. One function of the prostate gland is to help control urination by pressing directly against the part of the urethra that it surrounds. The main function of the prostate gland is to produce some of the substances that are found in normal semen, such as minerals and sugar. Semen is the fluid that transports the sperm to assist with reproduction. A man can manage quite well, however, without his prostate gland. (See the section on surgical treatment for prostate cancer.)

In a young man, the normal prostate gland is the size of a walnut (<30g). During normal aging, however, the gland usually grows larger. This hormone-related enlargement with aging is called b...

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SIDE EFFECTS

Clinical Trial Experience

The safety of all ELIGARD (leuprolide acetate) ® formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of ELIGARD (leuprolide acetate) ® 7.5 mg was evaluated in 8 surgically castrated males (Table 4). ELIGARD (leuprolide acetate) ®, 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 [see WARNINGS AND PRECAUTIONS].

During the clinical trials, injection sites were closely monitored. Refer to Table 3 for a summary of reported injection site events.

Table 3: 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 mild³
Pain (generally brief and mild)	4.3% of injections (18.3% of patients)	3.5% of injections (6.0% of patients)	2.3% of injections² (3.3% of patients)	4.6% of injections⁴
Erythema (generally brief and mild)	2.6% of injections (12.5% of patients)	0.9% of injections¹ (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 injections⁵
Pruritis	1.4% of injections (9.2% of patients)	0.4% of injections (0.9% of patients)
Induration	0.4% of injections (2.5% of patients)
Ulceration	0.1% of injections ( > 0.8% of patients)
¹ Erythema was reported following 2 injections of ELIGARD (leuprolide acetate) ® 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. ² A single event reported as moderate pain resolved within two minutes and all 3 mild pain events resolved within several days following injection of ELIGARD (leuprolide acetate) ® 30 mg. ³ Following injection of ELIGARD (leuprolide acetate) ® 30 mg, three of the 35 burning/stinging events were reported as moderate. ⁴ Transient 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 (leuprolide acetate) ® 45 mg. ⁵ Mild bruising was reported following 5 (2.3%) study injections and moderate bruising was reported following 2 ( < 1%) study injections of ELIGARD (leuprolide acetate) ® 45 mg.

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 (leuprolide acetate) ®, 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.

Table 4: Summary of Possible or Probably Related Systemic Adverse Events Reported by > 2% of Patients treated with ELIGARD (leuprolide acetate) ®

		7.5 mg	7.5 mg	22.5 mg	30 mg	45 mg
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 upto 8 months	1 injection every 6 months up to 12 months
Body System	Adverse Event		Number	(Percent)
Body as a	Malaise and Fatigue	21 (17.5 %)		7 (6.0%)	12 (13.3%)	13 (11.7%)
Whole	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%)
Renal/Urinary	Nocturia				2 (2.2%)
Gastrointestinal	Nausea			4 (3.4%)	2 (2.2%)
Gastrointestinal	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%)*
*Expected pharmacological consequences of testosterone suppression. In the patient populations studied with ELIGARD (leuprolide acetate) ® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe. In the patient population studied with ELIGARD (leuprolide acetate) ® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe. In the patient population studied with ELIGARD (leuprolide acetate) ® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe. In the patient population studied with ELIGARD (leuprolide acetate) ® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; none were severe.

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

Body System	Adverse Event
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
* Expected pharmacological consequences of testosterone suppression.

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

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.