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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.

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Eligard

Eligard

Eligard Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Eligard (leuprolide acetate) is used in men to treat the symptoms of prostate cancer. It is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids, and is also used to treat precocious (early-onset) puberty in both male and female children. Leuprolide is a man-made form of a hormone that regulates many processes in the body. Common side effects include hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, increased urination at night, mental/mood changes (e.g., depression, mood swings), dizziness, or mild burning/pain/bruising at the injection site.

Eligard is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period, depending on the dose. Other drugs may interact with Eligard. Tell your doctor all prescription and over-the-counter medications and supplements you use. Eligard must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Consult your doctor to discuss birth control. Non-hormonal birth control methods are recommended.

It is unknown if this drug passes into breast milk. Because the effects of this drug on a nursing infant are unknown, breast-feeding is not recommended. Our Eligard (leuprolide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Eligard in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • pain, burning, stinging, bruising, or redness where the medication was injected;
  • feeling like you might pass out;
  • painful or difficult urination;
  • urinating more often than usual;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
  • sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Rare but serious side effects may include:

  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use; and
  • loss of bowel or bladder control.

Less serious side effects may include:

  • acne, increased growth of facial hair;
  • breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
  • dizziness, weakness, tired feeling;
  • hot flashes, night sweats, chills, clammy skin;
  • nausea, diarrhea, constipation, stomach pain;
  • skin redness, itching, or scaling;
  • joint or muscle pain;
  • vaginal itching or discharge
  • breast swelling or tenderness;
  • testicle pain;
  • impotence, loss of interest in sex;
  • depression, sleep problems (insomnia), memory problems; or
  • redness, burning, stinging, or pain where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eligard (Leuprolide Acetate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Eligard Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, increased urination at night, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

During the first few weeks of treatment, your level of testosterone will actually increase before it decreases. This is a normal response by your body to this drug. This may sometimes result in new or worsening symptoms for a few weeks. If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor immediately if you experience any of the following serious side effects: bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, inability to move.

Tell your doctor right away if you have any serious side effects, including: new/worsening bone pain, easily broken bones, increased thirst/urination, mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression in children).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, irregular heartbeat, weakness on one side of the body, slurred speech, seizures.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Eligard (Leuprolide Acetate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Eligard FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Eligard (Leuprolide Acetate) »

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Eligard - User Reviews

Eligard User Reviews

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Here is a collection of user reviews for the medication Eligard sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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