What is ORIAHNN®? Oral Treatment for Heavy Bleeding Due to Uterine Fibroids

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

ORIAHNN is different—it's not a surgery, procedure, or birth control.

Proven heavy period reduction

A majority of women taking ORIAHNN had lighter periods at the final month of treatment.

And ORIAHNN quickly reduced the amount of bleeding—by half at Month 1.

See trial results

Hear about the broad range of women in the clinical trials and their results

Transcript

A closer look at how ORIAHNN was studied

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A closer look at how ORIAHNN was studied

[ORIAHNN logo]

What is ORIAHNN?
ORIAHNN^® is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.

Please see Use and Important Safety Information for ORIAHNN at the end of this video.
Please see Full Prescribing Information, including Medication Guide for ORIAHNN, on Oriahnn.com.

[ORIAHNN logo]

SAFETY CONSIDERATIONS
ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, and/or are obese. Stop taking ORIAHNN and talk to a doctor right away if you have symptoms of a heart attack, stroke, or blood clot.

Please see Use and Important Safety Information for ORIAHNN at the end of this video.
Please see Full Prescribing Information, including Medication Guide for ORIAHNN, on Oriahnn.com.

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How was ORIAHNN proven to work in clinical trials?

NAOMI:
How was ORIAHNN proven to work? I can show you how it worked for women in clinical trials…

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ORIAHNN lightened heavy periods for about 7 in 10 women
*In two 6‐month clinical trials of premenopausal women aged 25‐53 with heavy periods due to fibroids, about 7 in 10 women taking ORIAHNN had lighter periods at final month of treatment vs about 1 in 10 women taking placebo.

NAOMI:
because I was one of them! Hi! I’m Naomi.

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ONE OF MILLIONS

NAOMI:
One of millions of women with uterine fibroids. My gynecologist said one option to treat my heavy bleeding was surgery.

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SURGERY?

NAOMI:
But I wasn’t sure I wanted that right now.

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NON-SURGICAL OPTION

NAOMI:
I was looking for a non‐surgical option. So when she told me about the clinical trials for ORIAHNN to manage heavy menstrual bleeding due to uterine fibroids, I definitely wanted to take part.

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Who took part in the trials?

NAOMI:
Let’s see who else participated.

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Age: 25 to 53

NAOMI:
There were two 6-month clinical trials for ORIAHNN, which included 790 women aged 25 to 53 who were diagnosed with uterine fibroids.

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Weight: 108 lbs to 355 lbs
68% African American
29% Caucasian
3% Other

NAOMI:
The women varied in weight and race. Some had children and some did not.

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Amount of menstrual bleeding at start of trials
=about 1/3 cup
84 mL
Lowest

NAOMI:
At the start of the trials, menstrual bleeding ranged from 84 milliliters…

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Amount of menstrual bleeding at start of trials
=about 1 cup
240 mL
Average

NAOMI:
…to an average of 240 milliliters…

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Amount of menstrual bleeding at start of trials
=about 5 cups
1207 mL
Highest

NAOMI:
…to 1207 milliliters per period, which could mean a lot of pads and tampons!

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How did scientists know how much menstrual blood women lost?

NAOMI:
How did scientists know how much menstrual blood women lost? They measured it. Each month, we had to bring in all our used pads and tampons. Scientists then measured how much blood was on each of the supplies to see if our bleeding was reduced. To prove if ORIAHNN really worked, they split us into groups. One group took ORIAHNN. The other group took a placebo, which is a pill that doesn’t have any medicine in it.

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Pills were taken each morning and evening.

NAOMI:
We didn’t know which group we were in. We just took our pills daily, for 6 months, bringing in our used pads and tampons each month to measure our bleeding.

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What were the results of the clinical trials?

NAOMI:
What were the results of the clinical trials? ORIAHNN did lighten heavy periods.

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ORIAHNN
~7 in 10 HAD LIGHTER PERIODS
Lighter periods defined as at least 50% reduction from start of trial and to below 80 mL at final month of treatment.

NAOMI:
At the final month, about 7 in 10 women who took ORIAHNN had lighter periods.

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PLACEBO
~1 in 10 HAD LIGHTER PERIODS
Lighter periods defined as at least 50% reduction from start of trial and to below 80 mL at final month of treatment.

NAOMI:
On the other hand, about 1 in 10 women taking placebo showed that improvement.

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ORIAHNN	Start of Trial	Month 1
		51% Reduction

Results from Trial 2.
For Trial 1, women taking ORIAHNN saw a 52% (124 mL) average decrease at Month 1 and an 81% (189 mL) average decrease at Month 6.
Women taking placebo saw a 13% (33 mL) average decrease at Month 1 and a 3% (9 mL) average decrease at Month 6.

NAOMI:
On average with ORIAHNN, periods at the first monthly check-in were reduced by 122 milliliters. That’s 51% less than at the start of the trial.

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ORIAHNN	Start of Trial	Month 1
PLACEBO	Start of Trial	Month 1

Results from Trial 2.
For Trial 1, women taking ORIAHNN saw a 52% (124 mL) average decrease at Month 1 and an 81% (189 mL) average decrease at Month 6.
Women taking placebo saw a 13% (33 mL) average decrease at Month 1 and a 3% (9 mL) average decrease at Month 6.

NAOMI:
By comparison, women taking placebo had an average reduction of 16 milliliters, or about 5%.

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ORIAHNN	Start of Trial	Month 1	Month 3	Month 6
PLACEBO	Start of Trial	Month 1	Month 3	Month 6

Results from Trial 2.
For Trial 1, women taking ORIAHNN saw a 52% (124 mL) average decrease at Month 1 and an 81% (189 mL) average decrease at Month 6.
Women taking placebo saw a 13% (33 mL) average decrease at Month 1 and a 3% (9 mL) average decrease at Month 6.

NAOMI:
Average bleeding reductions for women taking ORIAHNN were also lighter at months 3 and 6 of the trials.

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Start of Trial

Month 1

Month 3

Month 6

89% (-188 mL) Reduction

Results from Trial 2. Women taking placebo averaged an increase of 9% (+12 mL) at month 6.
For Trial 1, women taking ORIAHNN saw a 52% (124 mL) average decrease at Month 1 and an 81% (189 mL) average decrease at Month 6.
Women taking placebo saw a 13% (33 mL) average decrease at Month 1 and a 3% (9 mL) average decrease at Month 6.

NAOMI:
Overall, from the start of my trial to Month 6, the average bleeding reduction was 188 milliliters or 89%.

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Most Common Side Effects	ORIAHNN	PLACEBO
Hot flashes	22%	9%
Headache	9%	7%
Fatigue (tiredness)	6%	4%
Irregular periods	5%	1%

These side effects were reported in 5% or more of women and at a greater percentage than placebo. These are not all the possible side effects of ORIAHNN.

NAOMI:
The most common side effects reported in the clinical trials were hot flashes, headache, fatigue, and irregular periods. In the clinical trials, ORIAHNN lightened heavy periods due to uterine fibroids for the majority of us. Lighter periods could be possible for you too.

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SHARE

NAOMI:
Ask your gynecologist if ORIAHNN is right for you. And share this video with the women in your life who have heavy menstrual bleeding due to uterine fibroids.

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ORIAHNN logo

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USE

ORIAHNN^® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORIAHNN?

ORIAHNN may cause serious side effects, including:

Cardiovascular Conditions
- ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, or are obese. Stop taking ORIAHNN and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:
  - Leg pain or swelling that will not go away
  - Sudden shortness of breath
  - Double vision, bulging of the eyes, or sudden blindness (partial or complete)
  - Pain or pressure in your chest, arm, or jaw
  - Sudden, severe headache unlike your usual headaches
  - Weakness or numbness in an arm or leg, or trouble speaking

Bone Loss (Decreased Bone Mineral Density [BMD])
- While taking ORIAHNN, your estrogen levels may be low. Low estrogen levels can lead to BMD loss.
- If you have bone loss on ORIAHNN, your BMD may improve after you stop taking ORIAHNN, but complete recovery may not occur. It is unknown if these BMD changes could increase your risk for broken bones as you age. For this reason, you should not take ORIAHNN for more than 24 months.
- Your healthcare provider 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.
- Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle.

Effects on Pregnancy
- Do not take ORIAHNN if you are pregnant or trying to become pregnant, as it may increase the risk of early pregnancy loss.
- If you think you may be pregnant, stop taking ORIAHNN right away and call your HCP.
- ORIAHNN can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other pregnancy signs like breast tenderness, weight gain, and nausea.
- ORIAHNN does not prevent pregnancy. You will need to use effective methods of birth control while taking ORIAHNN and for 28 days after you stop taking ORIAHNN. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
- Talk to your HCP about which birth control to use during treatment with ORIAHNN. Your HCP may change the birth control you are on before you start taking ORIAHNN.

Do not take ORIAHNN if you:

Have or have had:
- A stroke or heart attack
- A problem that makes your blood clot more than normal
- Blood circulation disorder
- Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- Blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- High blood pressure not well controlled by medicine
- Diabetes with kidney, eye, nerve, or blood vessel damage
- Certain kinds of headaches with numbness, weakness, or changes in vision, or have migraine headaches with aura if you are over age 35
- Breast cancer or any cancer that is sensitive to female hormones
- Osteoporosis
- Unexplained vaginal bleeding that has not been diagnosed
- Liver problems including liver disease
Smoke and are over 35 years old
Are taking medicines known as strong OATP1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix. Ask your HCP if you are not sure if you are taking this type of medicine.
Have had a serious allergic reaction to elagolix, estradiol, norethindrone acetate, or any of the ingredients in ORIAHNN. Ask your HCP if you are not sure.
FD&C Yellow No. 5 (tartrazine) is an ingredient in ORIAHNN, which may cause an allergic type reaction such as bronchial asthma in some patients who are also allergic to aspirin.

What should I discuss with my HCP before taking ORIAHNN?

Tell your HCP about all your medical conditions, including if you:

Have or have had:
- Broken bones or other conditions that may cause bone problems
- Depression, mood swings, or suicidal thoughts or behavior
- Yellowing of the skin or eyes (jaundice) or jaundice caused by pregnancy (cholestasis of pregnancy)
Are scheduled for surgery. ORIAHNN may increase your risk of blood clots after surgery. Your doctor may advise you to stop taking ORIAHNN before you have surgery. If this happens, talk to your HCP about when to restart ORIAHNN after surgery.
Are pregnant or think you may be pregnant.
Are breastfeeding. It is not known if ORIAHNN can pass into your breastmilk. Talk to your HCP about the best way to feed your baby if you take ORIAHNN.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Women on thyroid or cortisol replacement therapy may need increased doses of the hormone.

Keep a list of your medicines with you to show to your HCP and pharmacist when you get a new medicine.

What should I avoid while taking ORIAHNN?

Avoid grapefruit and grapefruit juice during treatment with ORIAHNN since they may affect the level of ORIAHNN in your blood, which may increase side effects.

What are the possible side effects of ORIAHNN?

ORIAHNN can cause additional serious side effects, including:

Suicidal thoughts, suicidal behavior, and worsening of mood. ORIAHNN may cause suicidal thoughts or actions. Call your HCP or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. Pay attention to any changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings.
Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.
High blood pressure. You should see your HCP to check your blood pressure regularly.
Gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy.
Increases in blood sugar, cholesterol, and fat (triglyceride) levels.
Hair loss (alopecia). Hair loss and hair thinning can happen while taking ORIAHNN, and it can continue even after you stop taking ORIAHNN. It is not known if this hair loss or hair thinning is reversible. Talk to your HCP if this is a concern for you.
Changes in laboratory tests, including thyroid and other hormone, cholesterol, and blood clotting tests.

The most common side effects of ORIAHNN include: hot flashes, headache, fatigue, and irregular periods.

These are not all of the possible side effects of ORIAHNN. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.

Take ORIAHNN exactly as your HCP tells you. The recommended oral dosage of ORIAHNN is one yellow/white capsule in the morning and one blue/white capsule in the evening, with or without food.

This is the most important information to know about ORIAHNN. For more information, talk to your doctor or HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

US-ORIA-210459

Please see the Full Prescribing Information, including the Medication Guide.

About 7 in 10 women taking ORIAHNN had lighter periods at the final month of treatment.

See proven results

How does ORIAHNN work?

ORIAHNN is a combination medication:

Elagolix, the main ingredient, dials down estrogen and progesterone. Lowering these hormones can help lighten heavy periods, but this 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)

Got questions? We've got answers.

Proven Results in Clinical Trials

What Is
ORIAHNN?

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

Proven heavy period reduction