Oriahnn is a brand-name prescription drug. It’s FDA-approved to reduce heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus). Oriahnn is used in adults who haven’t gone through menopause.
Oriahnn should not be used for more than 24 months because of the risk of bone loss. (For more information on bone loss, refer to the “Oriahnn side effects” section below.)
Drug details
Oriahnn contains three active drugs: elagolix, estradiol, and norethindrone acetate. Elagolix belongs to a group of drugs called gonadotropin-releasing hormone (GnRH) antagonists. Estradiol is a type of estrogen hormone, and norethindrone acetate is a type of progestin hormone. Oriahnn lightens your periods by lowering the sex hormone levels in your body.
Oriahnn comes as two separate capsules that you swallow. Each capsule is taken at a different time each day.
The white and yellow capsule contains 300 milligrams (mg) of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate. You’ll likely take the white and yellow capsule once per day in the morning. The white and blue capsule contains 300 mg of elagolix. You’ll likely take the white and blue capsule once per day in the evening.
FDA approval
In 2020, the Food and Drug Administration (FDA) approved Oriahnn to treat heavy menstrual bleeding related to uterine fibroids.
Effectiveness
To learn about the effectiveness of Oriahnn, refer to the “Oriahnn uses” section below.
Oriahnn can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Oriahnn. These lists don’t include all possible side effects.
For more information about the possible side effects of Oriahnn, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Oriahnn, you can do so through MedWatch.
Mild side effects
Mild side effects of Oriahnn can include:*
- fatigue
- headache
- hot flashes†
- abnormal uterine bleeding,† such as spotting or bleeding between periods
Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
* This is a partial list of mild side effects from Oriahnn. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Oriahnn’s prescribing information.
† For more information about this side effect, refer to “Side effect details” below.
Serious side effects
Serious side effects from Oriahnn aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Gallbladder disease. Symptoms can include:
- dark-colored urine
- fever
- jaundice (yellowing of your skin or the whites of your eyes)
- loss of appetite
- nausea and vomiting
- sudden abdominal (belly) pain
- Hypertension (high blood pressure). This condition doesn’t usually cause any symptoms.
- High blood sugar. Symptoms can include:
- feeling more thirsty than usual
- urinating more often than usual
- High cholesterol. This condition doesn’t usually cause any symptoms.
- Liver problems. Symptoms can include:
- dark-colored urine
- fatigue
- jaundice
- nausea and vomiting
- upper-right abdominal pain
- Hair thinning or hair loss, which may or may not be reversible
- Allergic reaction.*
- Blood clots and blood vessel disorders,*† such as heart attack or stroke.
- Bone loss.*
- Mood changes, including suicidal thoughts and behaviors.*
* For more information about these side effects, refer to “Side effect details” below.
† Oriahnn has a
Side effect details
You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.
Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Oriahnn.
Some people may have an allergic reaction to the drug itself. Other people may have a reaction to a certain ingredient in Oriahnn called yellow No. 5. (To learn more, refer to “Can I take Oriahnn if I’m allergic to food coloring, food dyes, or aspirin?” under “Common questions related to Oriahnn” below.)
It isn’t known how many people in clinical trials had an allergic reaction to Oriahnn or yellow No. 5.
Symptoms of a mild allergic reaction can include:
- skin rash
- itchiness
- flushing
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
Call your doctor right away if you have an allergic reaction to Oriahnn, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Blood clots and blood vessel disorders
In some people, taking Oriahnn can increase the risk of developing blood clots and blood vessel disorders, such as heart attack or stroke. Oriahnn has a
Certain people may have a higher risk of developing blood clots or blood vessel disorders with Oriahnn. This includes people older than age 35 years who smoke. It also includes people who have obesity, diabetes, high cholesterol, or unmanaged hypertension (high blood pressure).
Blood clots
Taking Oriahnn can raise your risk for blood clots. Types of blood clots that could occur with Oriahnn include:
- deep vein thrombosis (DVT), a blood clot in a deep vein
- pulmonary embolism (PE), a blood clot in the lungs
- retinal vein thrombosis, a blood clot in the retina (a layer of tissue in the back of your eye)
Symptoms of DVTs and PEs may include pain in your arm, chest, or leg, or swelling in your leg or arm. You could also experience trouble breathing or warmth in the affected area.
Symptoms of a blood clot in the retina may include bulging eyes, double vision, migraine. Symptoms also include sudden vision changes in one eye, such as loss of vision or blurry vision.
In clinical trials, adults were given either Oriahnn or a placebo (a treatment with no active drug) to treat their heavy menstrual bleeding. Of the people taking Oriahnn:
- 0.2% had a DVT after taking Oriahnn for 30 days
- 0.2% had a PE after taking Oriahnn for 8 months
It isn’t known how many people who took a placebo had a DVT or PE. In addition, it isn’t known how many people had a blood clot in their retina after taking Oriahnn or a placebo.
If you’re concerned about your risk for blood clots while taking Oriahnn, talk with your doctor.
Heart attack
Oriahnn treatment may increase the risk of a heart attack. The percentage of people who may have had a heart attack while taking Oriahnn in clinical trials isn’t known.
Symptoms of a heart attack include a tightness, squeezing, pressure, or pain in your chest that may spread to your neck, back, or jaw.
If you’re concerned about your risk for a heart attack during your Oriahnn treatment, talk with your doctor.
Stroke
Taking Oriahnn may raise the risk of a stroke. The percentage of people who may have had a stroke while taking Oriahnn in clinical trials isn’t known.
Symptoms of a stroke include:
- severe headache
- trouble seeing, speaking, or walking
- weakness in one side of your face, one leg, or one arm
If you’re concerned about your risk for a stroke while taking Oriahnn, talk with your doctor.
Hot flashes
Hot flashes are a possible side effect of Oriahnn. In clinical trials of adults, hot flashes happened in:
- 22% of people who took Oriahnn
- 9% of people who took a placebo
The amount of time these hot flashes lasted isn’t known. Of the people who took Oriahnn, 1% experienced hot flashes so bothersome that they had to stop taking the drug. It’s not known how many people may have stopped taking a placebo because of hot flashes.
If you’re concerned about having hot flashes while taking Oriahnn, talk with your doctor. They can suggest ways to help relieve this side effect.
Abnormal uterine bleeding
Taking Oriahnn may lead to abnormal uterine bleeding, such as spotting or bleeding between periods.
In clinical trials of adults, abnormal uterine bleeding occurred in:
- 5% of those who took Oriahnn
- 1% of those who took a placebo
The amount of time this side effect lasted isn’t known. Of people who took Oriahnn in these studies, 1% stopped taking the drug because of abnormal uterine bleeding. It’s not known how many people may have stopped taking a placebo because of abnormal uterine bleeding.
If you have concerns about abnormal uterine bleeding while taking Oriahnn, talk with your doctor.
Bone loss
Taking Oriahnn may cause loss of bone mineral density (also called bone loss). Bone mineral density is a term that describes bone thickness and strength.
It’s not known how often this side effect may have occurred in clinical trials of Oriahnn. The risk of bone loss is higher if Oriahnn is taken for more than 24 months. (Oriahnn should not be used for more than 24 months because of this risk of bone loss.)
Loss of bone mineral density may increase your risk for bone fractures. In clinical trials:
- 1.5% of people who took Oriahnn experienced a fracture
- 0.5% of people who took placebo experienced a fracture
Some of the fractures that happened in people who took Oriahnn took place after treatment with the drug had been stopped. The impact of treatment with Oriahnn on your risk for future fractures isn’t currently known.
It’s possible that bone loss caused by Oriahnn could be reversed after the drug is stopped.
Talk with your doctor about your risk for bone loss while taking Oriahnn. They can suggest ways to help keep your bones healthy and strong, such as taking vitamin D and calcium.
Before and while you’re taking Oriahnn, your doctor may want to order what is known as a DEXA scan to check your bone mineral density. If they detect a decrease that is troubling, they may decide to have you stop taking Oriahnn.
Suicidal thoughts and behaviors
Oriahnn may increase the risk of mood disorders, including suicidal thoughts and behaviors.
In clinical trials of adults, depression, depressed mood, or crying with no known cause were reported by:
- 3% of those who took Oriahnn
- 1% of those who took a placebo (a treatment with no active drug)
In these trials, no one taking Oriahnn or a placebo died by suicide.
Tell your doctor right away if you have any of the following changes in mood or behavior while using Oriahnn:
- aggressive behavior
- agitation (feeling bothered or restless)
- anger
- anxiety
- depression
- irritability
- other unusual changes in mood or behavior
If you have any thoughts of suicide while taking Oriahnn, call 911 or your local emergency number right away.
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
Oriahnn is available only as a brand-name medication. It’s not currently available in generic form.
A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.
Oriahnn contains three active drugs: elagolix, estradiol, and norethindrone acetate.
As with all medications, the cost of Oriahnn can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Before approving coverage for Oriahnn, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If you’re not sure if you’ll need to get prior authorization for Oriahnn, contact your insurance company.
Financial and insurance assistance
If you need financial support to pay for Oriahnn, or if you need help understanding your insurance coverage, help is available.
A patient assistance program called myAbbVie Assist is available for Oriahnn. This program may help lower the cost of the drug for you. For more information and to find out if you’re eligible for support, call 800-222-6885 or visit the program website.
Generic version
Oriahnn isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.
Your doctor will start you on the typical dosage of Oriahnn used to reduce heavy menstrual bleeding. Then they’ll monitor your condition over time to decide if you need to keep taking the drug.
Your doctor will ultimately prescribe Oriahnn for the shortest amount of time needed to treat your heavy menstrual bleeding while keeping your risk for side effects low. (For more information on side effects, refer to the “Oriahnn side effects” section below.)
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Oriahnn comes as two separate capsules that you swallow:
- The white and yellow capsule contains three active ingredients: 300 milligrams (mg) of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate.
- The white and blue capsule contains one active ingredient: 300 mg of elagolix.
Dosage for heavy menstrual bleeding due to uterine fibroids
Oriahnn is approved to treat heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus).
The typical dosage of Oriahnn is:
- one white and yellow capsule taken once a day in the morning
- one white and blue capsule taken once a day in the evening
You should take each dose of Oriahnn at about the same time each morning and evening. You can take each dose with or without food.
Oriahnn capsules come in a blister pack. This is a special type of packaging that organizes the drug by its daily doses. Each blister pack contains 1 week of Oriahnn doses (seven morning doses and seven evening doses).
What if I miss a dose?
If you miss a dose of Oriahnn, take the missed dose as soon as you remember. However, if it’s been more than 4 hours since your missed dose was supposed to be taken, just skip the missed dose. Then take your next dose at its usual time.
Do not take extra doses to make up for your missed dose. Doing this can raise your risk for side effects. (For more information, refer to the “Oriahnn side effects” section below.)
To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.
Will I need to use this drug long term?
No, Oriahnn isn’t meant to be used as a long-term treatment. Oriahnn shouldn’t be used for more than 24 months because of its risk of bone loss. (For more information on bone loss, refer to the “Oriahnn side effects” section below.)
The Food and Drug Administration (FDA) approves prescription drugs such as Oriahnn to treat certain conditions. Oriahnn may also be prescribed off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.
Oriahnn for heavy menstrual bleeding due to uterine fibroids
Oriahnn is FDA-approved to reduce heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus). It’s used in adults who haven’t gone through menopause.
Oriahnn should not be used for more than 24 months because of its risk of bone loss. (For more information on bone loss, refer to the “Oriahnn side effects” section above.)
Uterine fibroids are noncancerous tumors on the uterus. Fibroids can vary in size and shape. They can also grow slowly over time and may be present for several years before they cause any symptoms.
Besides heavy menstrual bleeding, symptoms of fibroids can include abdominal pain or cramps, constipation, and pain in the pelvis or lower back.
The exact reason that fibroids cause heavy menstrual bleeding isn’t known. The pressure of the fibroids against the uterus wall may cause the uterus to bleed more than usual. Fibroids may also keep the uterus from being able to tighten its blood vessels to stop the bleeding.
You can visit our women’s health hub for more information about this and other topics.
Effectiveness for heavy menstrual bleeding due to uterine fibroids
Oriahnn has been found to be effective for reducing heavy menstrual bleeding related to uterine fibroids.
In two clinical trials each lasting 6 months, adults were given either Oriahnn or a placebo (a treatment with no active drug). Researchers wanted to determine how many people would respond to either treatment. “Responding to treatment” was defined as:
- losing less than 80 milliliters (mL) of menstrual blood in the last month of treatment, and
- having a 50% decrease in the amount of menstrual blood lost during the last month of treatment compared with before treatment started
The results showed that:
- 68.5% to 76.5% of people who took Oriahnn responded to treatment
- 8.7% to 10.5% of people who took a placebo responded to treatment
For some people, taking Oriahnn reduced their bleeding so much that they didn’t have a period anymore (although spotting may still have occurred). Researchers also looked at the percentage of people who didn’t have a period during the last month of treatment. The results showed that:
- 57% to 61% of people who took Oriahnn had no period
- 4% to 5% of people who took a placebo had no period
Oriahnn and children
Oriahnn isn’t approved for use in children. It isn’t known if the drug is safe or effective for children.
There aren’t any known interactions between Oriahnn and alcohol. However, drinking alcohol while taking Oriahnn may worsen certain side effects of the drug. (For more information about side effects, refer to the “Oriahnn side effects” section above.)
Side effects that could be worsened with alcohol use include:
- Blood clots. Drinking alcohol may raise your risk for developing a blood clot. Taking Oriahnn can also raise your risk for a blood clot. In fact, the drug has a
boxed warning about this risk.* Therefore, drinking alcohol during your treatment with Oriahnn can increase your chances of having a blood clot even more. - Hot flashes. Drinking alcohol can cause flushing. Taking Oriahnn can cause hot flashes, and flushing can happen during hot flashes. Therefore, drinking alcohol while taking Oriahnn could make your hot flashes worse.
If you drink alcohol, talk with your doctor about how much is safe for you to drink while using Oriahnn.
* A boxed warning is the most serious warning from the FDA. For more information, refer to the “Oriahnn side effects” section above.
Oriahnn can interact with several other medications. It can also interact with certain foods.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Oriahnn and other medications
Below is a list of medications that can interact with Oriahnn. This list doesn’t contain all drugs that may interact with Oriahnn.
Before taking Oriahnn, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Oriahnn and certain medications that affect how your body breaks down Oriahnn
Certain drugs can interact with Oriahnn because they block the activity of enzymes (proteins) that break down Oriahnn in your body. This increases the level of Oriahnn in your blood, which can raise your risk for side effects from the drug.
Examples of these drugs include:
- certain antibiotics, such as clarithromycin (Biaxin) and erythromycin (Ery-Tab)
- certain antifungals, such as itraconazole (Sporanox) and ketoconazole
- certain antivirals, such as ritonavir (Norvir)
Another antibiotic, rifampin (Rifadin), can also raise levels of Oriahnn in your blood. This is because it blocks a different type of protein, called a transporter. Transporters distribute drugs throughout your body and clear them from your body. According to Oriahnn’s manufacturer, you should not take Oriahnn with rifampin because of the risk for increased Oriahnn levels in your blood. This could raise your risk for side effects from the drug.
Other drugs can interact with Oriahnn by increasing the activity of enzymes that break Oriahnn down in your body. This decreases the level of Oriahnn in your blood, which can make the drug less effective. Examples of these drugs include certain seizure medications such as carbamazepine (Carbatrol, Tegretol), and phenytoin (Dilantin).
Before starting Oriahnn, talk with your doctor about any drugs you currently take. They can help make sure your other medications are safe to take with Oriahnn.
Oriahnn and certain medications that affect how your body breaks down other drugs
Using certain other drugs with Oriahnn may make the other drugs less effective. This happens because Oriahnn can increase the activity of enzymes that break these drugs down in your body. This lowers the level of these drugs in your blood.
Examples of these drugs include:
- benzodiazepines, such as midazolam
- statins, such as rosuvastatin (Crestor)
Oriahnn may also raise your risk for side effects from other drugs. This happens because Oriahnn can block the activity of enzymes that break these drugs down in your body. This raises the level of these drugs in your blood.
Examples of these drugs include:
- digoxin (Lanoxin), which is used for heart failure
- proton pump inhibitors, such as omeprazole (Prilosec)
Talk with your doctor or pharmacist about all medications that you take before starting Oriahnn. They can determine whether any of your medications may interact with Oriahnn.
Oriahnn and herbs and supplements
There aren’t any herbs or supplements that have been specifically reported to interact with Oriahnn. However, you should still check with your doctor or pharmacist before using any of these products while taking Oriahnn.
Oriahnn and foods
Eating grapefruit or drinking grapefruit juice while taking Oriahnn may increase the level of Oriahnn in your blood. This could raise your risk for side effects from Oriahnn. (To learn about possible side effects, refer to the “Oriahnn side effects” section above.) If you have questions about eating certain foods with Oriahnn, talk with your doctor.
Oriahnn and lab tests
Oriahnn may affect the results of certain lab tests, including:
- thyroid function tests
- cortisol level tests
- tests to check the levels of hormones such as testosterone and estrogen
- blood tests, such as blood clotting tests
- glucose tolerance test
- cholesterol test
Make sure the healthcare professionals performing these tests know that you’re taking Oriahnn. If you have questions about how Oriahnn may affect your lab tests, talk with your doctor.
Other drugs are available that can treat heavy menstrual bleeding related to uterine fibroids (noncancerous tumors on the uterus). Some may be a better fit for you than others. If you’re interested in finding an alternative to Oriahnn, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.
Alternatives for heavy menstrual bleeding due to uterine fibroids
Examples of other drugs that may be used to treat heavy menstrual bleeding caused by uterine fibroids include:
- goserelin (Zoladex)
- leuprolide (Eligard, Lupron Depot)
- levonorgestrel intrauterine device (IUD) (Kyleena, Liletta, Mirena, Skyla)
- birth control pills (Camila, Elinest, Ortho Micronor)
- progesterone (Endometrin, Prometrium)
- tranexamic acid (Lysteda)
- triptorelin (Trelstar)
- ulipristal (Ella)
You may be wondering how Oriahnn compares to similar drugs, such as Orilissa. The following table gives an overview of these two drugs.
Oriahnn | Orilissa | |
Active drug | elagolix, estradiol, and norethindrone acetate | elagolix |
Form | two oral capsules | oral tablet |
Uses | reducing heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus) | treating moderate to severe pain due to endometriosis |
These drugs cause similar side effects, though Orilissa may cause fewer severe side effects than Oriahnn. You can refer to the details in the prescribing information for Oriahnn and Orilissa. You can also talk with your doctor or pharmacist about similarities and differences between these drugs.
You may be wondering how Oriahnn compares to similar drugs, such as Myfembree. The following table gives an overview of these two drugs.
Oriahnn | Myfembree | |
Active drug | elagolix, estradiol, and norethindrone acetate | relugolix, estradiol, and norethindrone acetate |
Form | two oral capsules | oral tablet |
Uses | reducing heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus) | reducing heavy menstrual bleeding caused by uterine fibroids; treating moderate to severe pain due to endometriosis |
Both Oriahnn and Myfembree should not be taken for more than 24 months because of the risk of bone loss.
These drugs cause similar side effects. For details, you can refer to the prescribing information for Oriahnn and Myfembree. You can also talk with your doctor or pharmacist for more information about how these drugs compare.
You should take Oriahnn according to your doctor’s or healthcare professional’s instructions.
Oriahnn comes as two different capsules that you swallow: a white and yellow capsule and a white and blue capsule.
When to take
You’ll likely take one white and yellow capsule once per day, in the morning. You’ll likely take one white and blue capsule once per day, in the evening.
Oriahnn capsules come in a blister pack. This is a special type of packaging that organizes the drug by its daily doses. Each blister pack contains 1 week of Oriahnn doses (seven morning doses and seven evening doses).
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Taking Oriahnn with food
You can take Oriahnn with or without food.
Can Oriahnn be crushed, split, or chewed?
No, you should not crush, split, or chew Oriahnn capsules. The manufacturer of Oriahnn hasn’t stated whether the capsules can be opened and their contents sprinkled on soft food, like applesauce. Talk with your doctor or pharmacist if you have trouble swallowing Oriahnn capsules.
Oriahnn is FDA-approved to reduce heavy menstrual bleeding caused by uterine fibroids. It can be used in adults who haven’t gone through menopause.
About uterine fibroids
Uterine fibroids are noncancerous tumors on the uterus. Fibroids can vary in size and shape. They can also grow slowly over time and may be present for several years before they cause any symptoms.
Symptoms of fibroids can include:
- abdominal pain or cramps
- constipation
- heavy menstrual bleeding
- pain in the pelvis or lower back
Fibroids can lead to other health problems, such as anemia (low red blood cell counts), infertility (inability to conceive a child), and miscarriage (loss of pregnancy).
The exact reason that fibroids cause heavy menstrual bleeding isn’t known. The pressure of the fibroids against the uterus wall may cause the uterus to bleed more than usual. Fibroids may also keep the uterus from being able to tighten its blood vessels to stop the bleeding.
What Oriahnn does
Oriahnn works by lowering the levels of certain sex hormones in your body. Lower levels of sex hormones typically help reduce menstrual bleeding.
Oriahnn itself contains sex hormones. However, the combination of hormones in Oriahnn helps reduce your levels of other sex hormones in your body that cause heavy menstrual bleeding. This can help lighten your periods.
Oriahnn is made up of three active drugs: elagolix, estradiol, and norethindrone acetate. Elagolix belongs to a group of drugs called gonadotropin-releasing hormone (GnRH) antagonists. Estradiol is a type of estrogen hormone. And norethindrone acetate is a type of progestin hormone.
How long does it take to work?
It may take about 1 month for Oriahnn to start working and for your menstrual bleeding to lighten. If you have questions about when you should start seeing results from Oriahnn, talk with your doctor.
Oriahnn is not safe to take during pregnancy. When used during pregnancy, Oriahnn may cause miscarriage (loss of pregnancy). The risk of pregnancy loss is higher during the first few months of pregnancy.
Before you start Oriahnn, you’ll likely take a pregnancy test to confirm that you aren’t pregnant. If you become pregnant while taking Oriahnn, stop taking it and tell your doctor right away.
Keep in mind that taking Oriahnn can reduce or stop your menstrual bleeding. Because menstrual bleeding usually stops during pregnancy, this effect of the drug can make it hard to tell if you’re pregnant. Therefore, you may need to look for other signs of pregnancy, such as nausea, tender breasts, or weight gain.
A pregnancy registry is currently collecting information on the effects of Oriahnn when taken during pregnancy. To learn more, you can talk with your doctor, visit the registry website, or call the pregnancy registry at 833-782-7241.
It is not safe to take Oriahnn during pregnancy. If you’re sexually active and you can become pregnant, talk with your doctor about your birth control needs while you’re taking Oriahnn.
It isn’t known if hormonal birth control makes Oriahnn less effective. For this reason, you should use nonhormonal birth control methods while taking the drug and for at least 1 week after your last dose.
Examples of nonhormonal birth control include:
For more information about taking Oriahnn during pregnancy, refer to the “Oriahnn and pregnancy” section above.
It’s unknown whether Oriahnn is safe to take while breastfeeding. It also isn’t known if Oriahnn can pass into breast milk during breastfeeding. Some of the active drugs found in Oriahnn are known to pass into breast milk, but Oriahnn itself hasn’t been studied.
The effects of Oriahnn on a breastfed child also haven’t been studied. However, the drug can reduce the amount of breast milk produced by the body.
It’s important to note that if you’re sexually active, your doctor will likely recommend using nonhormonal birth control if you take Oriahnn while breastfeeding. (For more information, refer to the “Oriahnn and pregnancy” and “Oriahnn and birth control” sections above.)
If you’re breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of taking Oriahnn.
Here are answers to some frequently asked questions related to Oriahnn.
Will Oriahnn cure my condition?
No, Oriahnn won’t cure heavy menstrual bleeding related to uterine fibroids. As long as you’re taking the drug, it’ll help manage your bleeding. However, Oriahnn won’t continue to help with your heavy menstrual bleeding after you stop taking it. And it won’t get rid of the fibroids that cause heavy bleeding.
The only way to cure heavy menstrual bleeding related to uterine fibroids is to have a hysterectomy (a procedure to remove your uterus).
Talk with your doctor about the best way to manage your heavy menstrual bleeding related to uterine fibroids.
Will Oriahnn affect my ability to get pregnant?
It isn’t known if Oriahnn will affect your ability to get pregnant. Animal studies haven’t shown the drug to have any negative effects on fertility (the ability to conceive a child). However, animal studies don’t always predict what will happen in humans.
Having fibroids (noncancerous tumors on the uterus) can cause fertility problems. Oriahnn is used to treat heavy menstrual bleeding in adults who have fibroids. Therefore, some people who take Oriahnn may have trouble getting pregnant because of their fibroids.
It’s important to note that Oriahnn is not safe to take during pregnancy, so you should not try to get pregnant while taking this drug. Oriahnn may cause early miscarriage (loss of pregnancy). If you’re sexually active, you should use nonhormonal birth control methods while taking the drug. (For more information, refer to the “Oriahnn and pregnancy” and “Oriahnn and birth control” sections above.)
If you have questions about how your condition or treatment may affect your ability to get pregnant, talk with your doctor.
Why do fibroids cause heavy menstrual bleeding?
The exact reason that fibroids cause heavy menstrual bleeding isn’t known. The pressure of the fibroids against the uterus wall may cause the uterus to bleed more than usual. Fibroids may also keep the uterus from being able to tighten its blood vessels to stop the bleeding.
If you have questions about how fibroids affect your menstrual bleeding, talk with your doctor.
Can I take Oriahnn if I’m allergic to food coloring, food dyes, or aspirin?
It depends on your specific allergy, but you should not take Oriahnn if you have an allergy to yellow No. 5. In addition, you should not take Oriahnn if you’re allergic to aspirin.
Oriahnn contains yellow No. 5, which is an artificial coloring used in some foods, cosmetics, and drugs. In rare cases, some people may have an allergic reaction to this ingredient. (For more information on allergic reaction, refer to the “Oriahnn side effects” section above.)
It’s more common for people who are allergic to aspirin to also be allergic to yellow No. 5. That’s why you may not be able to take Oriahnn if you have an allergy to aspirin.
Before you start your Oriahnn treatment, talk with your doctor or pharmacist about any allergies you have to food coloring, food dye, or drugs. They can determine whether it’s safe for you to take Oriahnn.
How long can I take Oriahnn?
You should not take Oriahnn for more than 24 months. This is because Oriahnn can lower the levels of estrogen in your blood, which may cause loss of bone mineral density (also called bone loss). Bone mineral density is a term that describes bone thickness and strength.
Bone density loss might raise your risk for broken bones as you get older. (For more information on bone loss as a possible side effect of Oriahnn, refer to the “Oriahnn side effects” section above.)
Before you start taking Oriahnn, your doctor may test your bone mineral density using a DEXA scan. In addition, they may check your bone mineral density regularly during your treatment. Your doctor may also suggest taking vitamin D and calcium to keep your bones healthy and strong.
Your doctor will monitor your condition over time to decide if you need to keep taking Oriahnn. If you have questions about the treatment length that’s right for you, talk with your doctor.
Does Oriahnn cause hair loss?
Yes, Oriahnn may cause hair loss. In clinical trials, 3.5% of adults who were given Oriahnn experienced hair loss or hair thinning. Of these:
- 79% had mild hair loss
- 21% had moderate hair loss
- 29% had hair loss so bothersome that they stopped taking the drug
In comparison, 1% of adults who were given a placebo (treatment with no active drug) had hair loss or hair thinning. And no one taking a placebo stopped treatment because of hair loss.
It isn’t known whether hair loss caused by Oriahnn is reversible. Hair loss may continue even after treatment with Oriahnn stops.
If you’re concerned about hair loss while using Oriahnn, talk with your doctor. They may recommend a different treatment option for you.
This drug comes with several precautions.
FDA warning: Blood clot and blood vessel disorders
This drug has a
Using estrogen with progestin therapy (such as Oriahnn) can raise your risk for blood clots and blood vessel disorders. Specific types of blood clots may include deep vein thrombosis (DVT), pulmonary embolism (PE), or retinal vein thrombosis. Blood vessel disorders may include heart attack or stroke.
Oriahnn should not be prescribed for use in people who have a higher risk for these conditions. This includes people older than age 35 years who smoke. It also includes people who have obesity, diabetes, high cholesterol, or unmanaged hypertension (high blood pressure).
Other precautions
Before taking Oriahnn, talk with your doctor about your health history. Oriahnn may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Headaches or migraine. Tell your doctor if you’re over the age of 35 years and have headaches or migraine (a condition that causes severe headaches) with aura. (“Aura” describes symptoms that may happen before or during a migraine episode, such as speech, vision, or hearing problems.) These conditions can raise your risk for blood clots, heart attack, or stroke while taking Oriahnn. Your doctor may recommend a different treatment option for you if you have headaches or migraine episodes.
- Cancers that are sensitive to sex hormones. You may not be able to take Oriahnn if you have or have had certain cancers (such as some types of breast cancer) that are sensitive to sex hormones. This is because two of the active drugs in Oriahnn are sex hormones: estradiol (an estrogen hormone) and norethindrone acetate (a progestin hormone). Sex hormones can cause certain cancers to grow and spread. If you have a history of cancer that’s affected by sex hormones, your doctor may recommend a different treatment for you other than Oriahnn.
- Osteoporosis or bone problems. Oriahnn should not be used for more than 24 months because of the risk of bone loss. (For more information on bone loss, refer to the “Oriahnn side effects” section above.) If you have osteoporosis or other bone problems, you have an even greater risk of bone loss while using Oriahnn. For this reason, Oriahnn should not be used in people with osteoporosis. Be sure to tell your doctor if you have these conditions before you start taking Oriahnn.
- Unexplained vaginal bleeding. If you have unexplained vaginal bleeding that hasn’t been diagnosed with a cause, talk with your doctor. They may want to determine the cause of the bleeding before you start Oriahnn. They’ll want to rule out a more serious potential cause of the bleeding, such as cancer, before you start taking the drug.
- Liver problems. Taking Oriahnn can cause liver problems. If you already have liver problems, taking Oriahnn could make these problems worse. For this reason, people with existing liver problems should not take Oriahnn. Be sure to tell your doctor if you have any liver problems before you take Oriahnn.
- Blood circulation issues, including problems with your heart valve or heart rhythm. You should not take Oriahnn if you have issues with blood circulation, including heart valve problems or heart rhythm problems. These conditions can cause blood clots in your heart. Oriahnn can also raise your risk for blood clots. (Oriahnn has a
boxed warning for blood clots. A boxed warning is the most serious warning from the FDA. For more information, refer to “Oriahnn side effects” above). Before taking Oriahnn, tell your doctor about any blood circulation issues you may have, including heart valve or heart rhythm problems. - Allergy to aspirin or yellow No. 5. If you’re allergic to aspirin, tell your doctor before you start taking Oriahnn. People who have an aspirin allergy are at higher risk of having an allergic reaction to an ingredient in Oriahnn called yellow No. 5. People with an allergy to aspirin should not take Oriahnn. You should also tell your doctor if you know you have an allergy to the food dye yellow No. 5, as Oriahnn contains this ingredient. You should not take Oriahnn if you have an allergy to yellow No. 5.
- Depression, mood changes, or suicidal thoughts or behavior. Depression, mood changes, and suicidal thoughts or behavior are possible side effects of Oriahnn. If you have a history of these conditions, you may have a higher risk for these side effects. Before taking Oriahnn, talk with your doctor if you currently have or have had depression, mood changes, or suicidal thoughts or behavior. They may monitor your mood more closely during treatment or recommend a different treatment for you instead.
- Surgery. Having surgery raises your risk for a blood clot. Blood clots are also a possible side effect of Oriahnn. Therefore, taking Oriahnn before surgery can raise your risk of blood clots even more. Be sure to tell your doctor if you’re using Oriahnn and have a planned surgery. They’ll decide if it’s safe for you to keep taking Oriahnn. (For more information on blood clots and other side effects, refer to the “Oriahnn side effects” section above.)
- Allergic reaction. If you’ve had an allergic reaction to Oriahnn or any of its ingredients, your doctor will not prescribe Oriahnn. Ask your doctor what other medications are better options for you.
- Pregnancy. It is not safe to take Oriahnn during pregnancy. For more information, refer to the “Oriahnn and pregnancy” section above.
- Breastfeeding. It is not known if Oriahnn is safe to take while breastfeeding. For more information, refer to the “Oriahnn and breastfeeding” section above.
Note: For more information about the potential negative effects of Oriahnn, refer to the “Oriahnn side effects” section above.
Using more than the recommended dosage of Oriahnn can lead to serious side effects.
Do not use more Oriahnn than your doctor recommends.
Overdose symptoms
Symptoms of an overdose can include:
- abdominal pain
- fatigue
- drowsiness
- nausea and vomiting
- tender breasts
- withdrawal bleeding (period-like bleeding that happens after you stop taking hormones)
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
When you get Oriahnn from the pharmacy, the pharmacist will add an expiration date to the label on the packaging. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
Storage
How long a medication remains good can depend on many factors, including how and where you store the medication.
Oriahnn capsules should be stored at room temperature (68°F to 77°F/20°C to 25°C). For short periods of time, Oriahnn can be stored at a temperature of 59°F to 86°F (15°C to 30°C).
Keep the capsules in their carton and sealed packaging away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.
Disposal
If you no longer need to take Oriahnn and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment. Do not flush leftover Oriahnn capsules down the toilet.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.
The following information is provided for clinicians and other healthcare professionals.
Indications
Oriahnn is indicated for the treatment of heavy menstrual bleeding caused by uterine fibroids in adults who haven’t gone through menopause. The drug should not be used for more than 24 months because of its associated risk of bone loss.
Administration
Each daily dose of Oriahnn is split into two capsules. The yellow and white capsule contains 300 milligrams (mg) of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate. The blue and white capsule contains 300 mg of elagolix.
The recommended daily dosage of Oriahnn is one yellow and white capsule each morning and one blue and white capsule each evening. The doses can be taken with or without food.
Mechanism of action
Elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, competitively binds to GnRH receptors that are located in the pituitary gland. This decreases the amount of circulating follicle-stimulating hormone and luteinizing hormone. In turn, blood concentrations of estradiol and progesterone are suppressed, resulting in a reduction in bleeding related to uterine fibroids.
Estradiol helps to counteract the estrogen-lowering effect of elagolix that may lead to bone loss.
Norethindrone acetate is a progestin that helps to counteract the potential adverse effects associated with unopposed estrogen.
Pharmacokinetics and metabolism
When given on an empty stomach, each component of Oriahnn reaches maximum drug concentrations within 1 to 2 hours after administration of a single dose. The maximum drug concentration is decreased by one-fourth to one-half in the presence of a high fat meal.
Oriahnn is hepatically metabolized by CYP3A, CYP2D6, CYP2C8, and uridine glucuronosyl transferases. Each component has an elimination half-life between 5.9 and 14.5 hours.
Drug exposure in people with hepatic impairment is three times to seven times higher compared with people whose hepatic function is normal. The pharmacokinetics of Elagolix are not meaningfully affected by renal function, dialysis, race, ethnicity, body weight, or body mass index.
Contraindications
Oriahnn is contraindicated in people who:
- are pregnant
- have undiagnosed abnormal vaginal bleeding
- have liver disease
- have osteoporosis
- have or have had breast cancer or other cancers that are sensitive to hormones such as estrogen
- are at high risk of having arterial thromboembolism, venous thromboembolism, or another thromboembolic disorder, such as females* who smoke and are older than age 35 years, and females with unmanaged hypertension, dyslipidemia, vascular disease, or obesity
- are taking concomitant OATP1B1 inhibitors, such as rifampin
- have hypersensitivity to Oriahnn or any of its ingredients
* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Storage
Oriahnn should be stored at room temperature (68°F to 77°F/20°C to 25°C). Temporary excursions of 59°F to 86°F (15°C to 30°C) are allowed.
The capsules should be kept in their sealed blister packaging and in their carton. Packaging should be kept away from light and should not be stored in areas where it could get damp or wet, such as bathrooms.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.