For U.S. Residents Only
IMPORTANT SAFETY IMFORMATION FOR ELIGARD
ELIGARD Side Effects
ELIGARD – A Hormonal Therapy for Prostate Cancer
ELIGARD is a prescription medication for the palliative treatment (management of
symptoms) of advanced prostate cancer. ELIGARD is an LHRH (luteinizing hormone-releasing
hormone) agonist. It is designed to reduce the amount of testosterone in the body
by reducing the testicles' production of testosterone. It is not a cure for advanced
prostate cancer.
ELIGARD is available in 4 different prescription doses, with dosing options for
treating your advanced prostate cancer. The ELIGARD 45 mg shot, is a 6-month hormone
therapy for the treatment of advanced prostate cancer. ELIGARD 45 mg gives you the
option of a full year of hormone therapy with 2 injections at 6 month intervals.
Ask your doctor if a 6-month dose would be appropriate for you. ELIGARD is also
available as a 1 month, 3 month, and 4 month dosing option.
ELIGARD decreases the level of male hormones in the body. As a result, ELIGARD may
cause side effects. The most common systemic adverse events include mild to severe
hot flashes/sweats, fatigue, weakness, fever, muscle pain, testicular shrinkage
and breast enlargement. Please see additional safety information below. The most
common injection site effects include temporary burning and stinging, pain, bruising,
and redness.
Elevated blood sugar and an increased risk of developing diabetes have been reported
in men receiving the drugs in ELIGARD’s class. Your doctor will monitor your blood
sugar levels. Increased risk of heart attack, sudden death due to heart attack,
and stroke has also been reported in men with the use of the drugs in ELIGARD’s class.
Your doctor will monitor you for heart disease.
It's important that you pay attention to how you're feeling and share that information
with your doctor or nurse. They may have suggestions beyond what's on this web site
on how to manage the effects.
For more information, see the ELIGARD
Prescribing Information or talk to your doctor or nurse.
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Most Common Systemic Side Effects of ELIGARD (reported by greater than 2% or more
of men) in clinical trials
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Dose
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Side Effects
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ELIGARD
7.5 mg
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- Hot flashes/sweats
- Fatigue
- Decrease in the size of the testes
- Dizziness
- Inflammation of the stomach/intestine
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ELIGARD
22.5 mg
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- Hot flashes/sweats
- Fatigue
- Nausea
- Joint Pain
- Itching
- Urinary frequency
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ELIGARD
30 mg
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- Hot flashes
- Fatigue
- Dizziness
- Clamminess
- Testicular atrophy (decrease in the size of the testes)
- Decreased libido
- Night sweats
- Gynecomastia (breast growth)
- Testicular pain
- Hair loss
- Frequent need to urinate, especially at night
- Myalgia (muscle pain)
- Nausea
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ELIGARD
45 mg
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- Hot flashes
- Fatigue
- Testicular atrophy (decrease in the size of the testes)
- Myalgia (muscle pain)
- Gynecomastia (breast growth)
- Weakness
- Night sweats
- Pain in limb
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Other Systemic Side Effects of ELIGARD (reported by fewer than 2% of men)
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Body System
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Adverse Event
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General
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Sweating, insomnia, syncope, rigors, weakness, lethargy
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Gastrointestinal
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Flatulence, constipation, dyspepsia
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Hematologic
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Decreased red blood cell count, hematocrit and hemoglobin
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Metabolic
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Weight gain
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Musculoskeletal
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Tremor, backache, joint pain, muscle atrophy, limb pain
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Nervous
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Disturbance of smell and taste, depression, vertigo
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Psychiatric
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Insomnia, depression, loss of libido*
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Renal/Urinary
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Difficulties with urination, pain on urination, scanty urination, bladder spasm,
blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia
aggravated
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Reproductive/Urogenital
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Testicular soreness/pain, impotence*, decreased libido*, gynecomastia*, breast soreness/tenderness*,
testicular atrophy*, erectile dysfunction, penile disorder*, reduced penis size
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Skin
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Alopecia, clamminess, night sweats*, sweating increased*
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Vascular
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Hypertension, hypotension
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* Expected pharmacological consequences of testosterone suppression
Important Safety Information
Other adverse events can occur that are not listed in these reports. Report any
side effects you may experience to your doctors.
- What side effects am I likely to experience?
- Can you recommend ways to manage side effects?
- Are the side effects permanent or temporary?
- Are there certain foods that might help?
- What form of exercise is right for me?
Important Safety Information for ELIGARD
ELIGARD should not be used by anyone who is allergic to any drug product in the
same class of products, or who is allergic to any of the ingredients of Eligard,
including leuprolide acetate. Life-threatening allergic reactions have been reported
with the drugs in Eligard’s class . Eligard should not be used in women who are
pregnant of may become pregnant. ELIGARD can cause pregnancy loss and harm to the
fetus when used by a pregnant woman.
Eligard, like other drugs in its class, causes a temporary increase in testosterone
during the first and second weeks of treatment. Patients may experience worsening
of symptoms or new symptoms during the first weeks of treatment, including bone
pain, nerve damage, blood in the urine, pressure on the spine, or difficulty urinating.
If your cancer has spread to the spine or urinary tract, urinary blockage or pressure
in the spine may occur and can sometimes lead to paralysis, which may be fatal.
You may require close medical attention during the first few weeks of therapy and
you should notify your doctor if you develop any new or worsened symptoms after
beginning treatment with Eligard.
Elevated blood sugar and an increased risk of developing diabetes have been reported
in men receiving the drugs in Eligard’s class. Your doctor will monitor your blood
sugar levels. Increased risk of heart attack, sudden death due to heart attack,
and stroke has also been reported in men with the use of the drugs in Eligard’s class.
Your doctor will monitor you for heart disease.
The most common injection site side effects are temporary burning and stinging,
pain, bruising and redness. The most common systemic adverse events include mild
to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess,
testicular shrinkage and breast enlargement. For more information on these and other
side effects, please talk to your doctor.
Indication
ELIGARD is a prescription drug, given by injection, for the management of advanced
prostate cancer. However, there is no known cure for prostate cancer.
Please see and full mixing and administration instructions.
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