Important
Safety Information
ELIGARD®
is used for the palliative treatment of advanced
prostate cancer. ELIGARD is a prescription
medication that must be administered by a health
care professional.
- ELIGARD should not be
used by anyone who is allergic to any of the
ingredients in ELIGARD or to any similar drugs.
- ELIGARD causes an
increase in testosterone during the first few
weeks of therapy and some men may experience new
or worsening symptoms of prostate cancer e.g.,
bone pain, urinary symptoms, or nerve problems
such as numbness, during this period. If your
cancer has spread to the urinary tract or spine,
urinary blockage or pressure on the spine that can
lead to paralysis may occur. Your doctor will
discuss with you the benefits and risks of taking
ELIGARD.
- Increased risk of heart
attack, sudden death due to heart problems and
stroke have also been reported in men taking
ELIGARD. ELIGARD may also affect electrical
activity in the heart that can cause an irregular
heartbeat. Your doctor will monitor you for heart
conditions.
- Elevated blood sugar and
an increased risk of developing diabetes have been
reported in men receiving ELIGARD. Your doctor
will monitor blood sugar levels.
- Convulsions have been
observed in patients taking leuprolide acetate,
including patients who have a history of seizures,
epilepsy, or brain disorders (related to blood
vessels, nerves, or tumors), and in those taking
medications associated with convulsions.
Convulsions have also been reported in patients
without any of these conditions.
- ELIGARD may cause fetal
harm when administered to a pregnant woman.
Expected hormonal changes that occur with ELIGARD
treatment increase the risk for pregnancy loss.
- ELIGARD
may impair fertility in males of reproductive
potential.
The most
common injection site reactions are transient burning
and stinging, pain, bruising, and redness. The most
common side effects include hot flashes/sweats,
fatigue, weakness, muscle pain, dizziness, clamminess,
testicular shrinkage, decreased erections and
enlargement of breasts. Other side effects, including
thinning of bones that may lead to fracture, and rare
but serious problems with the pituitary gland in the
brain, have been reported with ELIGARD.
These
are not all the possible side effects of ELIGARD.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088.
Please see Full
Prescribing Information
for additional Important Safety Information.
References
- Key
Statistics for Prostate Cancer. American Cancer
Society Website.
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Accessed July 2020.
- Risk
Factors for Prostate Cancer. Cancer Treatment
Centers of America Website.
https://www.cancercenter.com/cancer-types/prostate-cancer/risk-factors.
Accessed July 2020.
- ELIGARD®
(leuprolide acetate) for injectable suspension,
7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing
information. Fort Collins, CO: Tolmar
Therapeutics, Inc.; 2019.
- https://www.nccn.org/patients/guidelines/prostate/index.html.
Accessed January 2020
- Sartor
O. Eur Urol 2006
- Prettyman,
Urologic Nursing
2019