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| Things to Know About VANTAS®
This front and back, 8 ½ by 11 inch informational
sheet with a pocket for the PI explains 10 things
that is helpful for a patient to know about Once-Yearly
VANTAS.
More information about VANTAS and its possible
side effects is also provided on this card, so
the patient understands how the medicine may affect
them.
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| Patient Care Card This pocket
size card explains six things the patient should
do to keep the area where the VANTAS was implanted
clean and dry. This helps the patient remember
the after care instructions even after they leave
their doctor’s office.
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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.
References:
1. What are the key statistics about prostate cancer?
American Cancer Society Web site. Available at: http://www.cancer.org.
Accessed August 30, 2004.
2. Data on file. Indevus Pharmaceuticals, Inc.
3. McDavid K, Lee J, Fulton JP, et al. Prostate cancer
incidence and mortality rates and trends in the United
States and Canada. Public Health Rep. 2004;119:174-186.
4. Hernandez J, Thompson IM. Diagnosis and treatment
of prostate cancer. Med Clin N Am. 2004;88:267-279.
5. Prostate cancer: overview. Mayo Clinic Web site.
Available at: http://www.mayoclinic.com. Accessed July
15, 2004.
6. National Cancer Institute, U.S. National Institutes
of Health Web site. Prostate Cancer (PDQ®): Treatment.
Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient.
Accessed July 15, 2004.
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Prescribing Information
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