ONE demonstrated safety profile

Adverse reactions and discontinuation rates1

Adverse reactions occurring in at least 5% of women receiving ORIAHNN and at a greater frequency than placebo in ELARIS UF-1 and UF-2

Incidence

  ORIAHNN
(n=395)
Placebo
(n=196)
Hot flush
22% 9%
Headache 9% 7%
Fatigue 6% 4%
Metrorrhagia 5% 1%

Discontinuation

Low discontinuation due to any adverse reactions 

ORIAHNN

10%

Placebo

7%


No more than 1% of women taking ORIAHNN discontinued due to any one adverse reaction

Serious adverse events were reported in 3 (0.8%) women taking ORIAHNN in ELARIS UF-1 and UF-2. Two women had heavy menstrual bleeding and required blood transfusion due to anemia (0.5%) and 1 woman with a history of bariatric surgery had a laparoscopic cholecystectomy due to cholelithiasis.1

Bone mineral density considerations

BMD change from baseline at lumbar spine in women who received ORIAHNN® in ELARIS UF-1, UF-2, and UF-EXTEND BMD change from baseline at lumbar spine in women who received ORIAHNN® in ELARIS UF-1, UF-2, and UF-EXTEND BMD change from baseline at lumbar spine in women who received ORIAHNN® in ELARIS UF-1, UF-2, and UF-EXTEND

Bone mineral density information1

  • ORIAHNN use should be limited to 24 months to limit the impact on BMD
  • ORIAHNN may cause a decrease in BMD, which is greater with increasing duration of use and may not be completely reversible after stopping treatment
  • Assessment of BMD by DXA may be recommended when starting ORIAHNN and periodically thereafter
  • Consider discontinuing ORIAHNN if the risk associated with bone loss exceeds the potential benefit of treatment
  • ORIAHNN is contraindicated in women with known osteoporosis

More information about BMD

Learn more about Z-scores and fracture risk in clinical trials

BMD=bone mineral density; DXA=dual-energy x-ray absorptiometry.

Data was based off least squares mean.