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

Graph depicting the bone mineral density changes in women who received ORIAHNN. Graph depicting the bone mineral density changes in women who received ORIAHNN. Graph depicting the bone mineral density changes in women who received ORIAHNN.

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.

*The ORIAHNN free trial provides a single 28-day trial supply of ORIAHNN at no cost to new patients residing in the United States with a valid prescription for an FDA-approved indication of ORIAHNN and who enroll in Oriahnn Complete. The trial is intended solely to allow new patients not currently taking ORIAHNN to determine with their healthcare provider whether ORIAHNN is right for them. There is no obligation to continue use of ORIAHNN after the trial has concluded and this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORIAHNN trial supply will be dispensed only through an AbbVie-authorized pharmacy to the patient’s home address and may not be sold or further distributed. No claims for payment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial at any time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.

Data was based off least squares mean.