What is ORIAHNN?

ORIAHNN is an FDA-approved oral medication specifically made to reduce heavy periods due to uterine fibroids

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How does ORIAHNN work?

Uterus Icon.

ORIAHNN is a combination medication:

  • Elagolix, the main ingredient, dials down estrogen and progesterone. Lowering these hormones can help lighten heavy periods, but can also lead to possible side effects like bone loss
  • To help manage these side effects, ORIAHNN also contains 2 other ingredients: estradiol (E2) and norethindrone acetate (NETA)

What were the clinical trial results?

ORIAHNN was studied in two 6-month clinical trials, including premenopausal women aged 25-53.

ORIAHNN was proven to lighten heavy periods in about

7 in 10 women*

This meant bleeding volume was reduced by at least 50% from start of trial, and to below 80 mL (about 1/3 of a cup) at the final month of treatment.

*Compared with about 1 in 10 women taking placebo.

How quickly does ORIAHNN work?

Average periods were reduced quickly—by about half at Month 1 and about 85% at Month 3


Measuring cup depicting the amount of menstrual bleeding at the start of the ORIAHNN clinical trial.

Start of Trial

228 mL

Measuring cup depicting menstrual bleeding after month 1 of the ORIAHNN clinical trial.

Month 1

-122 mL

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51%

Measuring cup depicting menstrual bleeding after month 3 of the ORIAHNN clinical trial.

Month 3

-194 mL

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86%

Measuring cup depicting menstrual bleeding after month 6 of the ORIAHNN clinical trial.

Month 6

-188 mL

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89%

ORIAHNN values for Trial 2. Placebo values were 256 mL at start of trial and resulted in a 6% (16 mL) average decrease at Month 1, a 12% (27 mL) average decrease at Month 3, and a 9% (12 mL) average increase at Month 6.

For Trial 1, ORIAHNN values were 238 mL at start of trial, and resulted in a 52% (124 mL) average decrease at Month 1, an 82% (187 mL) average decrease at Month 3, and an 81% (189 mL) average decrease at Month 6. Placebo values were 259 mL at start of trial and resulted in a 13% (33 mL) average decrease at Month 1, a 4% (0.1 mL) average decrease at Month 3, and a 3% (9 mL) average decrease at Month 6.

What are the common side effects?

Most common side effects reported by women in the clinical trials


 
Most common side effects ORIAHNN Placebo

 
Hot flashes 22% 9%
Headache 9% 7%
Fatigue (tiredness) 6% 4%
Irregular periods 5% 1%

These are not all the possible side effects of ORIAHNN. Percentages based on 395 women who took ORIAHNN and 196 women who took placebo in two 6-month clinical trials. Table shows all adverse reactions reported in 5% or more of women and at a greater percentage than placebo.

How do you take ORIAHNN?

ORIAHNN Packaging Icon.

Packaging shown is not actual size.

Morning Icon.

Take 1 capsule in the morning


Evening Icon.

Take 1 capsule in the evening


Silverware Icon.

With or without food
 

Take at approximately the same times each day

Starting ORIAHNN

Once you and your doctor have decided ORIAHNN is right for you, be sure to:

  • Review the additional Important Safety Information at the bottom of this page
  • Verify you are not pregnant or start within 7 days after you start your period
  • Discuss an effective method of birth control to use during your treatment with ORIAHNN and for 28 days after you stop treatment because it does not prevent pregnancy
  • Go over your medical history; your doctor may order an x-ray test called a DXA scan to check your bone mineral density when you start taking ORIAHNN and periodically after you start because bone loss may occur
  • Schedule a follow-up appointment
  • Sign up for Oriahnn® Complete and get personalized support to help you start and stay on track with your prescribed treatment plan