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VANTAS is indicated in the palliative treatment of advanced prostate cancer.
VANTAS is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist
analogs, or any components in VANTAS. VANTAS is contraindicated in women and
pediatric patients and was not studied in women or children. VANTAS, like other
LHRH agonists, causes a transient increase in serum concentration of testosterone
during the first week of treatment. Patients may experience worsening of symptoms
or onset of new symptoms including bone pain, neuropathy, hematuria, or ureteral
or bladder outlet obstruction. Cases of ureteral obstruction and spinal cord
compression, which may contribute to paralysis with or without fatal complications,
have been reported with LHRH agonists. If spinal cord compression or renal impairment
develops, standard treatment of these complications should be instituted.
The most common systemic side effects were hot flashes (65.5%), asthenia (9.9%),
implant site reaction (5.8%), testicular atrophy (5.3%), and renal impairment
(4.7%). Five of the 8 patients had only a single occurrence of mild renal impairment
(defined as creatinine clearance 
30 and < 60 mL/min), which returned to a normal range by the next visit. The
most common local side effects were bruising (7.2%), and pain/soreness/tenderness
(3.6%).
Once serum testosterone concentrations at or below castrate level (
 50 ng/dL)
were achieved, a total of 4 patients (3%) demonstrated breakthrough during the
study. In one patient, a serum testosterone level of 63.1 ng/dL was reported
at week 44; this patient's serum testosterone level returned to 8.1 ng/dL at
the next reading. In another patient, a serum testosterone level of 3,340 ng/dL
was reported at week 40. This aberrant value was possibly related to lab error.
In two patients, serum testosterone rose above castrate level and the implant
could neither be palpated nor visualized with ultrasound.
Response to VANTAS should be monitored by measuring serum concentrations of
testosterone and PSA periodically, especially if the anticipated clinical or
biochemical response to treatment has not been achieved.
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