Safety and Tolerability Profile
Demonstrated Safety and Tolerability Profile—With
Once-Yearly VANTAS®
- There was a demonstrated safety profile throughout the duration of therapy (104 weeks) in a clinical trial.1
- —A VANTAS implant was implanted and removed once yearly
- No serious adverse events related to treatment were reported in a clinical trial2
- The incidence of adverse events was similar between week 1 to week 52 and week 52 to week 1043,4
Incidence of “Possibly or Probably Related” systemic adverse events reported by ≥2% of patients treated with VANTAS® for up to 24 months5
Adverse Events |
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| The safety of VANTAS was evaluated in 171 patients with prostate cancer treated for up to 36 months in 2 clinical trials. The pivotal study (study 301) consisted of 138 patients, while a separate supportive study (study 302) consisted of 33 patients. | ||
- To report an adverse event, call Endo Pharmaceuticals at 1-800-462-ENDO (3636)
In a multi-year clinical study, 94% of patients (n=113) elected to receive a second implant following their first year of treatment.5*
VANTAS, like other GnRH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment.
*Open-label multicenter phase 3 study in 138 patients with prostate cancer treated with a single VANTAS implant and evaluated for at least 60 weeks. At week 52, the study included the option for removal and insertion of a new implant, with evaluation for an additional 52 weeks. A total of 120 patients completed the initial 52-week treatment period. 113 patients underwent removal of the first implant and insertion of a second implant for another year of therapy.3,5
