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VANTAS (histrelin implant) is indicated in the palliative treatment of advanced prostate cancer.

Important Safety Information

VANTAS is contraindicated in women, pediatric patients and patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the other components of VANTAS.

VANTAS, like other LHRH 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 symptoms, including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction, cases of ureteral obstruction and spinal cord compression. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

Implant insertion and removal is a surgical procedure and should use aseptic technique. Careful adherence to the recommended insertion and removal procedures is recommended. In all clinical trials combined, an implant was not recovered in 8 patients, 2 of these 8 patients had serum testosterone levels above castrate level and the implant was not visualized with ultrasound. In all of the 8 patients, the implant was not palpable.

Response to VANTAS should be monitored measuring serum concentrations of testosterone and PSA periodically.

In clinical trials, the most common adverse reactions were hot flashes, fatigue, and implant site reaction. During post-marketing surveillance, rare cases of pituitary apoplexy have been reported after the administration of GnRH agonists.