Important Safety Information for ELIGARD (leuprolide acetate for injectable suspension)
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.
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 full Prescribing Information.