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Eligard

"The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

The FDA initially appr"...

Eligard

Side Effects
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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%)  
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%)*  
*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.

Read the Eligard (leuprolide acetate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No pharmacokinetic drug-drug interaction studies were conducted with ELIGARD (leuprolide acetate) ®.

Last reviewed on RxList: 3/3/2011
This monograph has been modified to include the generic and brand name in many instances.

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