VANTAS delivers more freedom
and flexibility in 4 key ways:

Chart your patients’ course for more freedom with a sound safety and
tolerability profile

The most common adverse events associated with VANTAS were injection site reactions, the majority of which were reported as mild and resolved within the first 2 weeks.

Percent of patients experiencing implant site reactions (N=138)

Bruising	7.2%	Pain/soreness/tenderness	3.6%
Redness	2.8%	Swelling	0.7%

Reactions persisted in 4 (2.8%) patients. An additional 4 (2.8%) patients developed application site reactions after the first 2 weeks following insertion

Incidence of “Possibly or Probably Related” systemic adverse events reported by
>2% of patients treated with VANTAS for up to 24 months

Adverse Event (N=171)

Hot flashes	65.5%	Renal impairment	4.7%	Headache	2.9%
Fatigue	9.9%	Gynecomastia	4.1%	Insomnia	2.9%
Implant site reaction	5.8%	Constipation	3.5%	Libido decreased	2.3%
Testicular atrophy	5.3%	Erectile dysfunction	3.5%	Weight increased	2.3%

Severe hot flashes were reported in 2.3% of patients
—25.4% of patients reported moderate hot flashes and 37.7% reported mild hot flashes

Over 30,000 implants administered ¹

Reference: 1. Data on file, Indevus Pharmaceuticals, Inc., 2003.

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.

VANTAS delivers more freedom and flexibility in 4 key ways:

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Important Safety Information

VANTAS delivers more freedom
and flexibility in 4 key ways: