A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Eligard Warnings, Precautions, Pregnancy, Nursing, Abuse - Leuprolide acetate
Eligard Warnings, Precautions, Pregnancy, Nursing, Abuse - Leuprolide acetate
WARNINGS
ELIGARD™ 7.5 mg, like other LH-RH agonists, causes a
transient increase in serum concentrations of testosterone during the first
week of treatment. Patients may experience worsening of symptoms or onset of
new signs and symptoms during the first few weeks of treatment, including bone
pain, neuropathy, hematuria, or bladder outlet obstruction. Isolated cases of
ureteral obstruction and/or spinal cord compression, which may contribute to
paralysis with or without fatal complications, have been observed in the palliative
treatment of advanced prostate cancer using LH-RH agonists. (see PRECAUTIONS
).
If spinal cord compression or renal impairment develops, standard
treatment of these complications should be instituted.
PRECAUTIONS
General: Patients with metastatic vertebral lesions and/or
with urinary tract obstruction should be closely observed during the first few
weeks of therapy (see WARNINGS
section).
Laboratory tests: Response to ELIGARD™ 7.5 mg should
be monitored by measuring serum concentrations of testosterone and prostate-specific
antigen periodically.
In the majority of patients, testosterone levels increased
above Baseline during the first week, declining thereafter to Baseline levels
or below by the end of the second week. Castrate levels were generally reached
within two to four weeks and once achieved were maintained for the duration
of treatment. No increases to above the castrate level occurred in any of the
patients.
Results of testosterone determinations are dependent on assay
methodology. It is advisable to be aware of the type and precision of the assay
methodology to make appropriate clinical and therapeutic decisions.
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