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Overview: Oriahnn is commonly used to treat uterine fibroids. Common side effects include hot flashes, tiredness, and headaches. Serious side effects are rare but include bone loss and suicidal thoughts. Oriahnn is a capsule you will swallow.

Uses

What is Oriahnn used for?

Oriahnn (elagolix/estradiol/norethindrone and elagolix) is commonly used to treat heavy menstrual bleeding caused by uterine fibroids.

Oriahnn may also be used for other conditions as determined by your healthcare provider.

How does Oriahnn work (mechanism of action)?

Oriahnn contains three different medicines: elagolix, estradiol, and norethindrone. Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist. It lowers the levels of specific hormones, called progesterone and estrogen, from being produced. Lowering levels of progesterone and estrogen in the body causes lighter periods with less bleeding. Estradiol (a form of estrogen) and norethindrone (a form of progesterone) are included to help prevent side effects due to the lower levels of progesterone and estrogen. 

How is Oriahnn supplied (dosage forms)?

Brands and other names

  • Oriahnn

Dosage forms and strengths

  • Elagolix/estradiol/norethindrone 300 mg/1 mg/0.5 mg oral capsules co-packaged with elagolix 300 mg oral capsules

How should I store Oriahnn?

Oriahnn should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Oriahnn?

The most common side effects of Oriahnn are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Hot flashes
  • Headache
  • Tiredness
  • Irregular periods or bleeding between periods

There may be other side effects of Oriahnn that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Oriahnn?

While less common, the most serious side effects of Oriahnn are described below, along with what to do if they happen.

Severe Allergic Reactions. Oriahnn may cause allergic reactions, which can be serious. Stop taking Oriahnn and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Oriahnn may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking Oriahnn and get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Weak Bones. Using Oriahnn for a long time may cause your bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause your bones to break (fracture) more easily. Tell your healthcare provider if you break a bone, and get a bone mineral density test if one is ordered for you.  

Suicidal Thoughts and Actions. Oriahnn may cause suicidal thoughts or actions in a small number of people. It may also cause depression and mood changes. People who have had depression, anxiety, or other mood changes in the past may be at higher risk. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Oriahnn. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Oriahnn may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your healthcare provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Hair Loss. Oriahnn may cause hair thinning and hair loss. Hair thinning or loss may not go away, even after you stop taking Oriahnn. Talk with your healthcare provider if you notice hair thinning or hair loss and this is a concern for you. 

Warnings & Precautions

Who should not use Oriahnn?

Allergies to Ingredients. People who are allergic to any of the following should not take Oriahnn.

  • Oriahnn
  • Elagolix
  • Estradiol
  • Norethindrone
  • Norethisterone
  • FD&C Yellow No. 5 (tartrazine) or a sensitivity to aspirin
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Oriahnn.

High Risk of Blood Clots. If you have certain factors that put you at a high risk of blood clots, you should not take Oriahnn. Some of these risk factors are listed below. Ask your healthcare provider if you are not sure if you have a high risk of blood clots.

  • Over the age of 35 and smoke
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • History of a heart attack or stroke
  • Any problems with your blood flow (circulation)
  • Heart valve problems or an irregular heart rhythm, such as atrial fibrillation
  • Blood clotting problems or a family history of blood clots
  • High blood pressure that is not treated, high cholesterol, diabetes, or obesity
  • Headaches that include problems with movement, speech, or eyesight, or migraine with aura, if you are over age 35

Previous Cancer. If you have previously had breast cancer or any cancer that was hormone-sensitive, you should not take Oriahnn.

Osteoporosis. Oriahnn should not be taken by people who have osteoporosis. Osteoporosis is a condition where your bones become thin and weak and may break more easily.

Liver Problems. Oriahnn should not be taken by people who have liver problems. Tell your healthcare provider if you have any current or prior liver problems. 

Abnormal Vaginal Bleeding. If you have abnormal vaginal bleeding that has not been diagnosed by a healthcare provider, you should not take Oriahnn.

Pregnancy. Do not take Oriahnn if you are pregnant or planning to become pregnant. If you become pregnant while taking Oriahnn, contact your healthcare provider right away. See the Pregnancy section for more details.

Drug Interactions. Oriahnn should not be used or taken while you are using certain other medicines. Before using Oriahnn, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Oriahnn before using it?

Do not take Oriahnn unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Oriahnn with other people, even if they have the same condition as you. It may harm them.

Keep Oriahnn out of the reach of children.

If you need to get rid of Oriahnn, you should not flush it down the toilet. Instead, take it to your pharmacy or visit www.fda.gov/drugdisposal to learn how to throw away the medicine safely. 

Keep all appointments, including for blood work, while you are taking Oriahnn. Oriahnn may cause an increase in your blood sugar, cholesterol, or triglyceride levels. 

What should I tell my healthcare provider before using Oriahnn?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Oriahnn is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have or have had any of the following.

  • Liver problems
  • Smoke or have smoked in the past
  • Heart problems, including heart disease 
  • Blood vessel problems or problems with your circulation
  • Blood clot problems or a family history of blood clot problems
  • Broken bones or health conditions that could cause bone problems, such as osteoporosis
  • Mental health problems, including depression, mood swings, or suicidal thoughts or behavior
  • Planned surgery or plans to be on bed rest or have limited movement
  • High cholesterol or high triglyceride levels
  • High blood pressure
  • Diabetes or prediabetes
  • Gallbladder problems

Pregnancy. Do not take Oriahnn while you are pregnant as it may increase the risk of pregnancy loss. Your healthcare provider will give you a test to make sure you are not pregnant before you start Oriahnn. You should use nonhormonal contraception, such as condoms, while taking Oriahnn and for 28 days after stopping it. Tell your healthcare provider if you are, think you are, or plan to become pregnant. 

Oriahnn can cause your period to stop or cause you to have irregular periods. This may make it hard to know if you are pregnant. Watch for other signs of pregnancy, such as nausea, weight gain, or breast tenderness. 

If you think you are pregnant, stop taking Oriahnn right away and contact your healthcare provider. If you become pregnant while taking Oriahnn, you can enroll in a Pregnancy Registry by calling 833-782-7241 or at www.bloompregnancyregistry.com. This registry collects safety information about the use of Oriahnn during pregnancy.

Breastfeeding. It is not known if Oriahnn passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Oriahnn?

For more information about Oriahnn, you can visit the manufacturer’s website at www.oriahnn.com or call them at 844-674-2466.

Interactions

Does Oriahnn interact with foods or drinks?

While taking Oriahnn, you should not eat grapefruit or drink anything that has grapefruit juice. Grapefruit can block your body’s ability to break down Oriahnn, causing too much of the medicine to stay in your body and increasing your risk for side effects.

It is unknown if drinking alcohol will affect Oriahnn.

Does Oriahnn interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Oriahnn.

  • A medicine known as an organic anion transporting polypeptide (OATP)1B1 inhibitor, such as cyclosporine or gemfibrozil
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD)
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • A benzodiazepine, such as midazolam, clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A statin, such as or rosuvastatin (Crestor), which is a medicine to lower cholesterol
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels 
  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions, asthma, or COPD 

Many other medicines may alter the blood levels of Oriahnn, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Oriahnn. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Oriahnn?

If you or someone else has used too much Oriahnn, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Oriahnn?

If you miss a dose, take it as soon as you remember, as long as it is within four hours of the time you were supposed to take it. If it has been more than four hours, skip the missed dose. Take your next dose at the regular time. Do not take double or extra doses.