Pronunciation:

el-a-GOE-lix, es-tra-DYE-ol, nor-ETH-in-drone AS-e-tate, el-a-GOE-lix

Brand Names:

• Oriahnn

Dosage Forms:

• Capsule

Warnings:

Thrombolic Disorders and Vascular EventsEstrogen and progestin combinations, including elagolix, estradiol, and norethindrone acetate plus elagolix, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.Elagolix, estradiol, and norethindrone acetate plus elagolix is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension .

Uses of This Medicine:

Elagolix, estradiol, and norethindrone combination is used to manage heavy menstrual bleeding caused by uterine leiomyomas (fibroids) in premenopausal women.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of elagolix, estradiol, and norethindrone combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of elagolix, estradiol, and norethindrone combination in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cyclosporine
• Eltrombopag
• Gemfibrozil
• Levoketoconazole
• Mavacamten
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Alprazolam
• Amifampridine
• Amiodarone
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Berotralstat
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Buprenorphine
• Bupropion
• Butabarbital
• Butalbital
• Capivasertib
• Capmatinib
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clarithromycin
• Clobazam
• Cloxacillin
• Clozapine
• Cobicistat
• Codeine
• Colesevelam
• Conivaptan
• Cosyntropin
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Daridorexant
• Darolutamide
• Darunavir
• Desogestrel
• Dexamethasone
• Dicloxacillin
• Dienogest
• Digoxin
• Dipyrone
• Donepezil
• Doxycycline
• Drospirenone
• Efavirenz
• Elagolix
• Elexacaftor
• Eliglustat
• Elvitegravir
• Enasidenib
• Encorafenib
• Entrectinib
• Enzalutamide
• Erdafitinib
• Eslicarbazepine Acetate
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Fedratinib
• Felbamate
• Fexinidazole
• Finerenone
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fruquintinib
• Gestodene
• Grazoprevir
• Griseofulvin
• Guar Gum
• Idelalisib
• Indinavir
• Isotretinoin
• Itraconazole
• Ivosidenib
• Ketoconazole
• Leflunomide
• Lemborexant
• Leniolisib
• Lesinurad
• Levonorgestrel
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Medroxyprogesterone
• Mephobarbital
• Meropenem
• Mestranol
• Methohexital
• Midazolam
• Midostaurin
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nirogacestat
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Octreotide
• Oliceridine
• Omaveloxolone
• Omeprazole
• Oxacillin
• Oxcarbazepine
• Oxycodone
• Oxytetracycline
• Palovarotene
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pimavanserin
• Pitolisant
• Pixantrone
• Posaconazole
• Pralsetinib
• Praziquantel
• Prednisolone
• Prednisone
• Primidone
• Quizartinib
• Red Clover
• Repotrectinib
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Saquinavir
• Secobarbital
• Segesterone
• Simeprevir
• Sirolimus Protein-Bound
• Somatrogon-ghla
• St John's Wort
• Sufentanil
• Sugammadex
• Sultamicillin
• Tacrolimus
• Tazemetostat
• Telaprevir
• Telithromycin
• Telotristat Ethyl
• Teriflunomide
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Tramadol
• Trofinetide
• Troglitazone
• Ubrogepant
• Ulipristal
• Valproic Acid
• Venetoclax
• Vonoprazan
• Voriconazole
• Voxilaprevir
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Lorazepam
• Parecoxib
• Selegiline
• Tacrine
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism) or history of or
• Breast cancer or history of or
• Heart attack, history of or
• Heart or blood vessel disease or
• Heart rhythm problems (eg, atrial fibrillation) or
• Hypertension (high blood pressure), uncontrolled or
• Liver disease, severe or
• Migraine headache or
• Osteoporosis (weak bones) or
• Stroke, history of—Should not be used in patients with these conditions.

• Allergy to aspirin—Use with caution. Oriahnn™ contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this condition.

• Cholestatic jaundice (bile problem) during pregnancy or previous pill use (eg, estrogen), history of or
• Diabetes or
• Dyslipidemia (high cholesterol in the blood) or
• Fracture (broken bone), history of or
• Gallbladder disease or
• Mental problems (eg, depression) or history of—Use with caution. May make these conditions worse.

• Obesity—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take the morning and evening capsules at about the same time each day.

Use this medicine within 7 days from the start of your menstrual period.

You may receive other medicines (eg, calcium or vitamin D supplements) to help reduce bone loss.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For heavy menstrual bleeding caused by uterine fibroids:
    • Adults—One white and yellow capsule [containing 300 milligrams (mg) elagolix, 1 mg estradiol, and 0.5 mg norethindrone] in the morning and one white and light blue capsule (containing 300 mg elagolix) in the evening for up to 24 months.
    • Children—Use and dose must be determined.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 4 hours from your normal dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and it is within 4 hours of your normal dose, take it as soon possible and go back to your regular dosing schedule. Do not take 2 doses to make up for a missed dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) during treatment and for at least 28 days after the last dose. If a pregnancy occurs while using the medicine, tell your doctor right away.

Do not use this medicine together with medicines called OATP 1B1 inhibitors that may increase elagolix levels in the blood. Your doctor should give you a list of these medicines.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using this medicine, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Check with your doctor if you have pain in the back, ribs, arms, or legs, or a decrease in your height.

This medicine may increase your risk of having hormone-sensitive cancer, including breast cancer. Check with your doctor right away if you have clear or bloody discharge from the nipple, an inverted nipple, dimpling of the breast skin, a lump in the breast or under the arm, crusting or scaling of the nipple, redness or swelling of the breast, or a sore on the skin of the breast that does not heal.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause changes in menstrual bleeding, which may decrease your ability to recognize pregnancy. Talk to your doctor if you have concerns.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 4 to 6 weeks before having surgery.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

bone loss

chest pain

dark urine

discouragement

dizziness

feeling sad or empty

general feeling of tiredness or weakness

headache

irritability

lack of appetite

light-colored stools

longer or heavier menstrual periods

loss of interest or pleasure

mood swings

nervousness

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

pounding in the ears

slow or fast heartbeat

stomach pain

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the calf

thoughts or attempts at killing oneself

trouble concentrating

trouble sleeping

vomiting

yellow eyes or skin

Rare

Anxiety

cough

fainting

trouble with breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

Less common

Chills

decreased interest in sexual intercourse

diarrhea

difficulty in moving

fever

full or bloated feeling

general feeling of discomfort or illness

increased weight

joint pain

loss in sexual ability, desire, drive, or performance

muscle pain or stiffness

nausea

pressure in the stomach

runny nose

shivering

sore throat

sweating

swelling of the stomach area

thinning or loss of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.