Simple to store.
Longer shelf life.
Treatment in the convenience
of a room temperature,
intramuscular injection.
INDICATIONS & USAGE1
LEUPROLIDE ACETATE INJECTION DEPOT (leuprolide acetate
for depot suspension) 22.5 mg for 3-month administration
(leuprolide acetate) is indicated for palliative treatment of
advanced prostate cancer.
IMPORTANT SAFETY INFORMATION1
Contraindications: Hypersensitivity: LEUPROLIDE ACETATE
INJECTION DEPOT is contraindicated in individuals with known
hypersensitivity to GnRH agonists or any of the excipients
in LEUPROLIDE ACETATE INJECTION DEPOT. Anaphylactic
reactions to GnRH agonists have been reported.
Warnings And Precautions:
x
Tumor Flare: LEUPROLIDE ACETATE INJECTION DEPOT
causes increases in serum levels of testosterone during
the first weeks of treatment. Isolated cases of ureteral
obstruction and spinal cord compression have been
observed, which may contribute to paralysis with or without
fatal complications. Transient worsening of symptoms may
develop. Patients may experience a temporary increase in
bone pain. Patients with metastatic vertebral lesions and/or
with urinary tract obstruction should be closely observed.
x
Hyperglycemia and Diabetes: Hyperglycemia and an
increased risk of developing diabetes have been reported in
men receiving GnRH agonists. Monitor blood glucose and/or
glycosylated hemoglobin (HbA1c) periodically
in patients receiving a GnRH.
x
Cardiovascular Diseases: Increased risk of developing
myocardial infarction, sudden cardiac death and stroke has
been reported, and should be evaluated carefully along with
cardiovascular risk factors. Patients receiving a GnRH agonist
should be monitored for symptoms and signs suggestive of
development of cardiovascular disease and be managed
accordingly.
x
Effect on QT/QTc Interval: Androgen deprivation therapy
may prolong the QT/QTc interval. Providers should consider
whether the benefits of androgen deprivation therapy
outweigh the potential risks in patients with congenital
long QT syndrome, congestive heart failure, frequent
electrolyte abnormalities, and in patients taking drugs
known to prolong the QT interval. Electrolyte abnormalities
should be corrected. Consider periodic monitoring of
electrocardiograms and electrolytes.
REFERENCES:
1. LEUPROLIDE PRESCRIBING INFORMATION, CIPLA, 2018.
2. Data on file. CIP-REF-LEU-001. Warren, NJ: Cipla USA; 2022
Medical Information:
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