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Physician Support
Patient Tolerability Reported in Clinical Trials		    
     
 

No serious adverse events were related to treatment

Leuprolide delivery can be terminated at any time by removing the implant.
  Most patients (118/131) had a new implant inserted for a second year of therapy following removal of the first implant(s).  

Side effects*
Hot flashes** 67.9%
Asthenia 7.6%
Gynecomastia** 6.9%
Depression 5.3%
Sweating** 5.3%

* Experienced in greater than 5% of patients in clinical trials.
** Expected pharmacologic consequences of androgen reduction.

Most local reactions were minor and resolved shortly following insertion/removal

The most common application site reactions were bruising (34.6%) and burning (5.6%).
  Other local adverse events included pulling, pressure, itching, erythema, pain, edema, and bleeding.  
  Local reactions persisted in 9.3% of patients; 10.3% of patients developed local reactions 2 weeks after insertion.  
  The majority of local reactions began and resolved within the first 2 weeks.  

Important safety considerations

Viadur is contraindicated in patients with hypersensitivity to GnRH, GnRH 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 or 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.  

All-inclusive implant kit facilitates in-office procedure

  Sterile kit provides everything required for the procedure, except sterile gloves.  
  In clinical trials, the mean physician time for initial insertion (from incision to close) was 4 minutes (range 1 - 15 minutes) excluding patient preparation and recovery time. Preparation time includes identifying insertion site, preparing sterile field, loading the implanter, and anesthetizing the area.  

Read further details about the Phase III Clinical Trial patient parameters. Phase III study was completed February 2000.

  
Details about 0% testosterone breakthroughs once coninuous suppressions was achieved
 
Further details about patient reactions during clinical trials
 
Further details about the clinical trials
 
Clinical Trial Phase III Parameters

 

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.