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FASLODEX safety

FASLODEX has a well understood tolerability profile, with a low incidence of treatment withdrawals

FASLODEX (fulvestrant) at either the 250-mg or the 500-mg dose has a well understood tolerability profile. From market experience, and until April 2010, the total cumulative worldwide patient exposure to FASLODEX has been estimated to be over 175,000 patient-years.1

FASLODEX side effects – 500 mg

FASLODEX 500 mg has a tolerability profile that is well understood

Efficacy benefits of FASLODEX 500 mg are achieved without compromising safety or tolerability.2

In a randomised, double-blind, parallel-group, multicentre, phase III study comparing the efficacy (time to progression) of FASLODEX 250 mg monthly and FASLODEX 500 mg monthly, tolerability was also assessed.

  • FASLODEX 500 mg had a safety profile consistent with that of FASLODEX 250 mg
  • There was no evidence that any adverse event was dose dependent

Please refer to the FASLODEX Summary of Product Characteristics (SmPC) for pooled safety data for multiple FASLODEX 500 mg trials.

FASLODEX 500 mg had a safety profile consistent with that of the 250-mg dose.

In the phase III advanced breast cancer trial comparing the efficacy and safety of FASLODEX 500 mg and FASLODEX 250 mg (the CONFIRM trial), FASLODEX 500 mg had a safety profile consistent with that of FASLODEX 250 mg, with no evidence of dose dependence for any adverse event.2

Eleven types of adverse events were predefined in the protocol for statistical analysis; the predefined adverse events and their percentage incidence are shown below for FASLODEX 500 mg and FASLODEX 250 mg, respectively  (FASLODEX 500 mg, n=361; FASLODEX 250 mg, n=374).3 Differences between the 2 treatments were not statistically significant.

  • Gastrointestinal disturbances (20.2% vs 20.3%)
  • Hot flashes (8.3% vs 6.1%)
  • Injection site reactions (13.6% vs 13.4%)
  • Ischemic cardiovascular disorders (1.4% vs 1.9%)
  • Joint disorders (18.8% vs 18.7%)
  • Osteoporosis (0.3% vs 0.0%)
  • Thromboembolic events (0.8% vs 1.6%)
  • Uinary tract infection (2.2 % vs 2.1%)
  • Vaginitis (0.8% vs 0.3%)
  • Weight gain (0.3% vs 0.0%)

There were no reports of endometrial dysplasia with either dose.

FASLODEX side effects – 250 mg

View FASLODEX 250mg SmPC

Seven types of adverse events were predefined in the protocol for statistical analysis in the combined clinical trial analysis; the predefined adverse events and their percentage incidence are shown below for FASLODEX and anastrozole, respectively  (FASLODEX 250 mg monthly, n=428; anastrozole 1 mg daily, n=423).3 Differences between the 2 treatments were not statistically significant.

  • Gastrointestinal disturbances: 46.3% vs 43.7%
  • Hot flushes: 21.0% vs 20.6%
  • Joint disorders: 5.4% vs 10.6%
  • Thromboembolic disease: 3.5% vs 4.0%
  • Urinary tract infection: 7.3% vs 4.3%
  • Vaginitis: 2.6% vs 1.9%
  • Weight gain: 0.9% vs 1.7%

The only adverse event category for which a significant difference was observed was joint disorders, which occurred less frequently in the FASLODEX 250 mg treatment arm (P=0.0036).

The FASLODEX injection – injection-site reactions

A low incidence of injection-site reactions

In these phase III trials, local injection-site reactions were mostly mild or moderate and occurred in about 1.1% of patients who received the single 5 ml FASLODEX injection. Across the 2 trials, only 2 patients in the FASLODEX group withdrew because of an injection-site reaction.3

For additional safety information, download the View FASLODEX 250mg SmPC.

FASLODEX 500 mg and 250 mg: no adverse effects seen in the endometrium or bone in the NEWEST study

In a phase II neoadjuvant study (NEWEST) comparing the biological and safety effects of 16 weeks of exposure to either FASLODEX 500 mg or FASLODEX 250 mg, neither dose had adverse effects on endometrial thickness or bone turnover markers.4

Find out more about the FASLODEX 0020/0021 and CONFIRM clinical trials.

References

  1. AstraZeneca, Data on file; FDX2810101.
  2. Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.
  3. Robertson JF et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 2003; 98(2): 229–38.
  4. Kuter I et al. Impact of fulvestrant 500 mg/month versus fulvestrant 250 mg/month on bone turnover markers and endometrial thickness: findings from the NEWEST study. Eur J Cancer 2010; 8: 64. Abstract 20.