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Viadur 99% Successful in Reducing Testosterone Within 2 to 4 Weeks		    
     
 
Testosterone was below the castrate threshold between weeks two and four in all but one patient, following the expected initial increase. Continuous androgen reduction in this patient occurred at week 28.
    Patients may experience worsening of symptoms or onset of new symptoms including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction, and spinal cord compression during the first week of treatment.  
  Once reduced, testosterone remained well below the castrate threshold for the duration of treatment.  
  Reduction was maintained following removal and insertion of a new implant with no rise in testosterone.  

Testosterone suppression over 2 years*

Androgen Suppression Graph

* These results are based on open-label, noncomparative, multicenter studies that evaluated 131 patients, 118 of whom continued therapy for 2 years. Two thirds of these patients had stage C or less advanced disease.1,2
1. Prescribing information--Viadur (leuprolide acetate implant), Bayer HealthCare Pharmaceuticals and ALZA Corporation, 2004.
2. Data on file. Bayer HealthCare Pharmaceuticals and ALZA Corporation.

For further information about clinical trial results, see Clinical Trial Phase III Results.

  
Details about 0% testosterone breakthroughs once continuous suppression was achieved
 
Further details about patient reactions during clinical trials
 
Further details about the clinical trials
 
Clinical Trial Phase III Results

 

Important Safety Considerations
Viadur is contraindicated in patients with hypersensitivity to Gn-RH, Gn-RH agonist analogs, or any of the components in Viadur.

Viadur is contraindicated in women and pediatric patients and was not studied in women or children.

Viadur, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience a worsening of symptoms or onset of new symptoms including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction, and spinal cord compression.

The most comment systemic side effects were hot flashes (67.9%), asthenia (7.6%), gynecomastia (6.9%), depression (5.3%), and sweating (5.3%). The most common local side effects were bruising (34.6%) and burning (5.6%).

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© Copyright 2007 Bayer HealthCare Pharmaceuticals. Viadur is a trademark of ALZA Corporation under license to Bayer HealthCare Pharmaceuticals. DUROS® is a registered trademark of ALZA Corporation.

The information provided on Bayer products is only intended for the United States audience. Regulatory requirements, regulations, laws, and distribution of information about drug products may vary from country to country. Product names and indications (product uses) also may be different in different countries. The prescribing information provided here is based on United States labeling and may not be appropriate outside of the United States.